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Long-acting inhaled therapy (beta-agonists, anticholinergics and steroids) for COPD: a network meta-analysis

  1. Kayleigh M Kew1,*,
  2. Sofia Dias2,
  3. Christopher J Cates1

Editorial Group: Cochrane Airways Group

Published Online: 26 MAR 2014

Assessed as up-to-date: 5 SEP 2013

DOI: 10.1002/14651858.CD010844.pub2


How to Cite

Kew KM, Dias S, Cates CJ. Long-acting inhaled therapy (beta-agonists, anticholinergics and steroids) for COPD: a network meta-analysis. Cochrane Database of Systematic Reviews 2014, Issue 3. Art. No.: CD010844. DOI: 10.1002/14651858.CD010844.pub2.

Author Information

  1. 1

    St George's, University of London, Population Health Research Institute, London, UK

  2. 2

    University of Bristol, School of Social and Community Medicine, Bristol, UK

*Kayleigh M Kew, Population Health Research Institute, St George's, University of London, Cranmer Terrace, London, SW17 0RE, UK. kkew@sgul.ac.uk.

Publication History

  1. Publication Status: New
  2. Published Online: 26 MAR 2014

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References

References to studies included in this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to ongoing studies
  4. Additional references
Abrahams 2013 {published data only}
  • Abrahams R, Moroni-Zentgraf P, Ramsdell J, Schmidt H, Joseph E, Karpel J. Safety and efficacy of the once-daily anticholinergic BEA2180 compared with tiotropium in patients with COPD. Respiratory Medicine 2013;107(6):854-62.
  • Abrahams R, Ramsdell J, Moroni-Zentgraf P, Schmidt H, Joseph B, Karpel J. Comparison of BEA2180 to tiotropium and placebo via respimat in patients with chronic obstructive pulmonary disease (COPD) [Abstract]. Respirology 2012;17(Suppl 2):46 [292].
ACCLAIM 2009 {published data only}
  • Jones P, Agusti A, Chanez P, Magnussen H, Fabbri L, Maroni J, et al. Efficacy and safety of aclidinium bromide, a novel long-acting muscarinic antagonist, in patients with moderate to severe COPD [Abstract]. European Respiratory Society Annual Congress; Sep 12-16; Vienna. 2009:[P2022].
  • Jones PE, Chanez P, Agusti A, Magnussen H, Fabbri L, Caracta C, et al. A phase III study evaluating aclidinium bromide, a novel long-acting antimuscarinic, in patients with COPD: ACCLAIM/COPD I [Abstract]. Thorax 2009;64(Suppl IV):A168 [P213].
  • Jones PW, Agusti A, Chanez P, Magnussen H, Fabbri L, Maroni J, et al. A phase III study evaluating aclidinium bromide, a novel long-acting antimuscarinic, in patients with COPD: ACCLAIM/COPD 1 [Abstract]. American Thoracic Society International Conference; May 15-20; San Diego. 2009:A6180 [Poster #207].
ACCLAIM II 2009 {published data only}
  • Jones PW, Rennard SI, Agusti A, Chanez P, Magnussen H, Fabbri L, et al. Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease. Respiratory Research 2011;12:55.
  • Rennard S, Donohue J, Bateman E, Gross N, Garcia Gil E, Caracta C. ACCLaim/COPD ii: efficacy and safety of aclidinium bromide; a novel long-acting muscarinic antagonist in COPD patients, a phase III study [Abstract]. European Respiratory Society Annual Congress; Sep 12-16; Vienna. 2009:[E4351].
  • Rennard S, Donohue J, Bateman E, Gross N, Garcia Gil E, Caracta C. Efficacy and safety of the novel, long-acting antimuscarinic, aclidinium bromide, in COPD patients in a phase III study: ACCLAIM/COPD II [Abstract]. American Thoracic Society International Conference; May 15-20; San Diego. 2009:A6178 [Poster #205].
Anzueto 2009 {published data only}
  • Anzueto A, Ferguson G, Feldman G, Selbert A, Chinsky K, Emmett A, et al. A randomized, double-blind trial comparing the effect of fluticasone/salmeterol 250/50 with salmeterol on COPD exacerbations [Abstract]. American Thoracic Society International Conference; May 16-21; Toronto. 2008:Poster #D40.
  • Anzueto A, Ferguson GT, Feldman G, Chinsky K, Seibert A, Emmett A, et al. Effect of fluticasone propionate/salmeterol (250/50) on COPD exacerbations and impact on patient outcomes. COPD 2009;6(5):320-9.
  • Dalal AA, Blanchette CM, Petersen H, St. Charles M. Cost-effectiveness of fluticasone propionate/salmeterol (250/50mcg) compared to salmeterol (50mcg) in patients with chronic obstructive pulmonary disease: economic evaluation of study SCO100250 [Abstract]. American Thoracic Society International Conference; May 15-20; San Diego. 2009:A1502 [Poster #K54].
  • DiSantostefano RL, Li H, Rubin DB, Stempel DA. Which patients with chronic obstructive pulmonary disease benefit from the addition of an inhaled corticosteroid to their bronchodilator? A cluster analysis. BMJ Open 2013;3(4):1-9.
  • GlaxoSmithKline. A randomized, double-blind, parallel-group, 52-week study to compare the effect of fluticasone propionate/salmeterol DISKUS 250/50mcg BID with salmeterol DISKUS 50mcg BID on the annual rate of moderate/severe exacerbations in subjects with chronic obstructive pulmonary disease (COPD). http://www.gsk-clinicalstudyregister.com/ (accessed 3 March 2014).
ATTAIN 2011 {published data only}
  • Agusti A, Jones PW, Bateman E, Singh D, Lamarca R, de Miquel G, et al. Improvement in symptoms and rescue medication use with aclidinium bromide in patients with chronic obstructive pulmonary disease: results from ATTAIN [Abstract]. European Respiratory Journal 2011;38(55):149s [P874].
  • Bateman ED, Singh D, Jones PW, Agusti A, Lamarca R, de Miquel G, et al. The ATTAIN study: safety and tolerability of aclidinium bromide in chronic obstructive pulmonary disease [Abstract]. European Respiratory Journal 2011;38(55):730s [P4005].
  • Jones P, Agusti A, Bateman E, Singh D, Lamarca R, De Miquel G, et al. Aclidinium bromide in patients with chronic obstructive pulmonary disease (COPD): reduction in exacerbations as defined by health-care utilization and the EXACT diary card [Abstract]. Chest 2011;140(4):529A.
  • Jones P, Agusti A, Bateman E, Singh D, Lamarca R, de Miquel G, et al. Aclidinium bromide in patients with chronic obstructive pulmonary disease: improvement in symptoms and health status in the ATTAIN study [Abstract]. Chest 2011;140(4):547A.
  • Jones P, Bateman E, Singh D, Agusti A, Lamarca R, De Miquel G, et al. Attain: efficacy and safety of twice-daily aclidinium bromide in chronic obstructive pulmonary disease (COPD) [Abstract]. Chest 2011;140(4):975A.
  • Jones PW, Agusti A, Bateman ED, Singh D, Lamarca R, de Miquel G, et al. Aclidinium bromide in patients with chronic obstructive pulmonary disease: efficacy and safety results from ATTAIN [Abstract]. American Journal of Respiratory and Critical Care Medicine 2011;183:A6350.
  • Jones PW, Agusti A, Bateman ED, Singh D, Lamarca R, de Miquel G, et al. Aclidinium bromide in patients with chronic obstructive pulmonary disease: improvement in health status in ATTAIN [Abstract]. European Respiratory Journal 2011;38(55):150s [P877].
  • Jones PW, Chuecos F, Lamarca R, Singh D, Agusti A, Bateman ED, et al. Unreported exacerbations of chronic obstructive pulmonary disease are associated with a reduction in health status: results from the ATTAIN study. American Journal of Respiratory and Critical Care Medicine 2013;187:A6072.
  • Jones PW, Singh D, Agusti A, Bateman ED, Lamarca R, de Miquel G, et al. Aclidinium bromide reduces COPD exacerbations as defined by healthcare utilisation and EXACT: results from ATTAIN [Abstract]. European Respiratory Journal 2012;40(Suppl 56):9s [195].
  • Jones PW, Singh D, Bateman ED, Agusti A, Lamarca R, de Miquel G, et al. Efficacy and safety of twice-daily aclidinium bromide in COPD patients: the ATTAIN study. European Respiratory Journal 2012;40(4):830-6.
  • Singh D, Bateman ED, Jones PW, Agusti A, Lamarca R, de Miquel G, et al. The ATTAIN study: bronchodilatory effect of aclidinium bromide in chronic obstructive pulmonary disease (COPD) [Abstract]. European Respiratory Journal 2011;38(55):149s [P875].
  • Singh D, Jones PW, Bateman ED, Agusti A, Lamarca R, De Miquel G, et al. Attain: twice-daily aclidinium bromide in patients with moderate to severe chronic obstructive pulmonary disease [Abstract]. Thorax 2011;66(Suppl 4):A171 [P255].
Bateman 2010a {published data only}
Bateman 2010b {published data only}
  • Bateman E, Singh D, Smith D, Disse B, Towse L, Massey D, et al. Efficacy and safety of tiotropium Respimat SMI in COPD in two 1-year randomized studies. International Journal of Chronic Obstructive Pulmonary Disease 2010;5:197-208.
  • Hodder R, Pavia D, Lee A, Bateman E. Lack of paradoxical bronchoconstriction after administration of tiotropium via Respimat Soft Mist Inhaler in COPD. International Journal of Chronic Obstructive Pulmonary Disease 2011;6(1):245-51.
Bateman 2013 [SHINE] {published data only}
  • Barnes N, Bateman E, Gallagher N, Green Y, Horton R, Henley M, et al. QVA149 once daily provides superior bronchodilation versus indacaterol, glycopyrronium, tiotropium and placebo: the SHINE study [Abstract]. Thorax 2012;67(Suppl 2):A147 [P192].
  • Bateman E, Ferguson GT, Barnes N, Gallagher N, Green Y, Horton R, et al. Benefits of dual bronchodilation with QVA149 once daily versus placebo, indacaterol, NVA237 and tiotropium in patients with COPD: the SHINE study [Abstract]. European Respiratory Journal 2012;40(Suppl 56):509s [2810].
  • Bateman E, Hashimoto S, Gallagher N, Green Y, Horton R, Henley M, et al. Glycopyrronium once daily provides rapid and sustained bronchodilation and is well tolerated in patients with COPD: the SHINE study [Abstract]. Thorax 2012;67(Suppl 2):A148 [P193].
  • Bateman ED, Ferguson GT, Barnes N, Gallagher N, Green Y, Henley M, et al. Dual bronchodilation with QVA149 versus single bronchodilator therapy: the SHINE study. European Respiratory Journal 2013;42(6):1484-94.
  • Bateman ED, Welte T, Hashimoto S, Gallagher N, Green Y, Horton R, et al. Dual bronchodilation with once-daily QVA149 provides superior bronchodilation compared to its mono-components and tiotropium in all subgroups of patients with COPD: the SHINE study. American Journal of Respiratory and Critical Care Medicine 2013;187:A4263.
  • Frith P, Thompson P, Wark P, Lindstrom S, Bateman E. Benefits of dual bronchodilation with QVA149 once daily versus placebo, indacaterol, NVA237 and tiotropium in patients with COPD: the Shine study [Abstract]. Respirology 2013;18(Suppl 2):20 [O041].
  • Welte T, Barnes N, Nagase T, Gallagher N, Green Y, Horton R, et al. QVA149 once daily is safe and well tolerated in patients with COPD: the SHINE study. American Journal of Respiratory and Critical Care Medicine 2013;187:A1478.
  • Welte T, Gallagher N, Green Y, Henley M, Banerji D. Dual bronchodilation with once-daily QVA149 provides significantly improved clinical outcomes versus mono-bronchodilator therapy: the SHINE study. American Journal of Respiratory and Critical Care Medicine 2013;187:A4272.
Bourbeau 1998 {published data only}
  • Bourbeau J, Rouleau MY, Boucher S. Randomised controlled trial of inhaled corticosteroids in patients with chronic obstructive pulmonary disease. Thorax 1998;53(6):477-82.
Brusasco 2003 {published data only}
  • Bateman ED, Hodder R, Miravitlles M, Lee A, Towse L, Serby C. A comparative trial of tiotropium, salmeterol and placebo: health-related quality of life. European Respiratory Journal 2001;18(Suppl 33):26s.
  • Bateman ED, Jenkins C, Korducki L, Keston S. Tiotropium (TIO) improves health care resource utilization (HRU) and patient disability in patients with COPD. American Journal of Respiratory and Critical Care Medicine 2002;165(Suppl 8):A111.
  • Brusasco V, Hodder R, Miravitlles M, Korducki L, Towse L, Kesten S. Health outcomes following treatment for six months with once daily tiotropium compared with twice daily salmeterol in patients with COPD. Thorax 2003;58(5):399-404.
  • Brusasco V, Menjoge SS, Kesten S. Flow and volume responders following treatment with tiotropium and salmeterol in patients with COPD [abstract]. American Thoracic Society 99th International Conference; May 16-21; Seattle. 2003.
  • Brusasco V, Menjoge SS, Kesten S. Flow and volume responders over 12 hours following treatment with tiotropium or salmeterol in patients with COPD [Abstract]. Proceedings of the American Thoracic Society; May 19-24; San Diego. 2006:A110 [Poster J10].
  • Brusasco V, Thompson P, Vincken W, Lee A, Towse L, Witek TJ. Improvement of dyspnea following six months of treatment with tiotropium but not with salmeterol in patients with COPD. European Respiratory Journal 2001;18(Suppl 33):26s.
  • Donohue JF. Alterations in bronchodilator effectiveness over six months with tiotropium and salmeterol. American Journal of Respiratory and Critical Care Medicine 2002;165(Suppl 8):A227.
  • Donohue JF, Menjoge S, Kesten S. Tolerance to bronchodilating effects of salmeterol in COPD. Respiratory Medicine 2003;97(9):1014-20.
  • Donohue JF, van Noord JA, Bateman ED, Langley SJ, Lee A, Witek TJ, et al. A 6-month, placebo-controlled study comparing lung function and health status changes in COPD patients treated with tiotropium or salmeterol. Chest 2002;122(1):47-55. [: 0012-3692]
  • Donohue JF, van Noord JA, Langley SJ, Lee A, Kesten S, Towse LJ. Superior bronchodilation of once daily tiotropium compared to twice daily salmeterol in patients with COPD. European Respiratory Journal 2001;18(Suppl 33):26s.
  • Gunther K, Lee A, Kesten S, Towse L. Superior bronchodilation of once daily tiotropium compared with twice daily salmeterol in patients with COPD [Abstract]. International Primary Care Respiratory Group Congress; Jun 7-9; Amsterdam. 2002:p112.
  • Rutten-van Mölken MP, Oostenbrink JB, Miravitlles M, Monz BU. Modelling the 5-year cost effectiveness of tiotropium, salmeterol and ipratropium for the treatment of chronic obstructive pulmonary disease in Spain. The European Journal of Health Economics: Health Economics in Prevention and Care 2007;8(2):123-35.
Burge 2000 [ISOLDE] {published data only}
  • Bale G, Martinez-Camblor P, Burge PS, Soriano JB. Long-term mortality follow-up of the ISOLDE participants: causes of death during 13 years after trial completion. Respiratory Medicine 2008;102(10):1468-72.
  • Bale GA, Burge PS, Burge C, Moore VC. The Isolde study 11-13 years on: what were the causes of death? [Abstract]. American Thoracic Society International Conference; May 18-23; San Francisco. 2007:Poster #H42.
  • Briggs AH, Lozano-Ortega G, Spencer S, Bale G, Spencer MD, Burge PS. Estimating the cost-effectiveness of fluticasone propionate for treating chronic obstructive pulmonary disease in the presence of missing data. Value in Health 2006;9(4):227-35.
  • Burge PS, Calverley PM, Jones PW, Spencer S, Anderson JA. Prednisolone response in patients with chronic obstructive pulmonary disease: results from the ISOLDE study. Thorax 2003;58(8):654-8.
  • Burge PS, Calverley PM, Jones PW, Spencer S, Anderson JA, Maslen TK. Randomised, double blind, placebo controlled study of fluticasone propionate in patients with moderate to severe chronic obstructive pulmonary disease: the ISOLDE trial. BMJ 2000;320(7245):1297-303.
  • Burge S, Sondhi S, Williams MK, Wilson K, Efthimiou J. An economic evaluation of fluticasone propionate in patients with moderate to severe chronic obstructive pulmonary disease (COPD) from the isolde trial. American Journal of Respiratory and Critical Care Medicine 2000;161(3 Suppl):A491.
  • Calverley P, Spencer S, Willits L, Burge PS, Jones P. Inhaled corticosteroids prevent treatment failure in COPD. American Journal of Respiratory and Critical Care Medicine 2002;165(8 Suppl):A271.
  • Calverley PM, Burge PS, Spencer S, Anderson JA, Jones PW. Bronchodilator reversibility testing in chronic obstructive pulmonary disease. Thorax 2003;58(8):659-64.
  • Calverley PM, Spencer S, Willits L, Burge PS, Jones PW, Group IO. Withdrawal from treatment as an outcome in the ISOLDE study of COPD. Chest 2003;124(4):1350-6.
  • Calverley PMA, Spencer S, Willets L, Burge PS, Jones PW. Inhaled corticosteroids prevent treatment failure in COPD. American Journal of Respiratory and Critical Care Medicine 2002;165(Suppl 8):A271.
  • D'Urzo AD. Withdrawal of treatment in the ISOLDE study. Chest 2004;125(6):2368.
  • Jarad NA, Wedzicha JA, Burge PS, Calverley PM. An observational study of inhaled corticosteroid withdrawal in stable chronic obstructive pulmonary disease. ISOLDE Study Group. Respiratory Medicine 1999;93(3):161-6.
  • Jones PW, Willits LR, Burge PS, Calverley PM, Inhaled Steroids in Obstructive Lung Disease in Europe Study Investigators. Disease severity and the effect of fluticasone propionate on chronic obstructive pulmonary disease exacerbations. European Respiratory Journal 2003;21(1):68-73.
  • Scott PH, Bale GA, Burge PS. COPD rapid decliners have better FEV1 response to inhaled fluticasone propionate 500 �g bd than slower decliners [abstract]. American Journal of Respiratory and Critical Care Medicine 2000;161(3 Suppl):A581.
  • Scott PH, Bale GA, Burge PS. Inhaled fluticasone propionate in COPD: better response in those with more rapid FEV1 decline. European Respiratory Journal 2000;16(Suppl 31):276s.
  • Spencer S, Calverley PM, Burge PS, Jones PW. Impact of preventing exacerbations on deterioration of health status in COPD. European Respiratory Journal 2004;23(5):698-702.
  • Spencer S, Calverley PM, Sherwood Burge P, Jones PW, ISOLDE Study Group. Inhaled Steroids in Obstructive Lung Disease. Health status deterioration in patients with chronic obstructive pulmonary disease. American Journal of Respiratory and Critical Care Medicine 2001;163(1):122-8.
Calverley 2003 [TRISTAN] {published data only}
  • Calverley P, Pauwels R, Vestbo J. Erratum. Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial. Lancet 2003;361(9369):1660.
  • Calverley P, Pauwels R, Vestbo J, Jones P, Pride N, Gulsvik A, et al. Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial. Lancet 2003;361(9356):449-56.
  • Calverley P, Pauwels RA, Jones PW, Anderson JA, Vestbos J. The severity of airways obstruction as a determinant of treatment response in COPD. International Journal of COPD 2006;1(3):209-18.
  • Calverley PMA, Pauwels R, Vestbo J, Jones P, Pride NB, Gulsvik A, et al. Safety of salmeterol/fluticasone propionate combination in the treatment of chronic obstructive pulmonary disease (COPD) for one year [abstract]. European Respiratory Journal 2002;20(Suppl 38):242s [P1572].
  • Calverley PMA, Pauwels RA, Vestbo J, Jones PW, Pride NB, Gulsvik A, et al. Clinical improvements with salmeterol/fluticasone propionate combination in differing severities of COPD. American Thoracic Society 99th International Conference; May 16-21; Seattle. 2003:A035 Poster D50.
  • Calverley PMA, Pauwels RA, Vestbo J, Jones PW, Pride NB, Gulsvik A, et al. Salmeterol/fluticasone propionate combination for one year provides greater clinical benefit than its individual components in COPD. American Journal of Respiratory and Critical Care Medicine 2002;165(Suppl 8):A226.
  • Claverley PMA, Pauwels RA, Vestbo J, Jones PW, Pride NB, Gulsvik A, et al. Salmeterol/fluticasone propionate combination for one year provides greater clinical benefit than its individual components in COPD. American Journal of Respiratory and Critical Care Medicine 2002;165(8 Suppl):A226.
  • Edin HM, Price MJ, Wire P, Lee B, Chang C, Darken P, et al. Fluticasone propionate/salmeterol combination improves quality of life in patients with COPD. American Journal of Respiratory and Critical Care Medicine 2001;163(5 Suppl):A506.
  • GlaxoSmithKline. A multicentre, randomised, double-blind, parallel group, placebo-controlled study to compare the efficacy and safety of the salmeterol/FP combination product at a strength of 50/500mcg bd with salmeterol 50mcg bd alone and FP 500mcg bd alone, delivered via the DISKUS™/ACCUHALER™, in the treatment of subjects with chronic obstructive pulmonary disease (COPD) for 12 months. http://www.gsk-clinicalstudyregister.com/study/SFCB3024#rs (accessed 11 February 2014).
  • Hunjan MK, Chandler F. Numbers needed to treat (NNT) to avoid an exacerbation in patients with chronic obstructive pulmonary disease (COPD) using salmeterol/fluticasone propionate combination (SFC) and associated costs [Abstract]. American Thoracic Society 100th International Conference; May 21-26; Orlando. 2004:D22 [Poster 503].
  • Hunjan MK, Williams DT. Costs of avoiding exacerbations in patients with chronic obstructive pulmonary disease (COPD) treated with salmeterol/fluticasone propionate combination (seretide) and salmeterol [Abstract]. European Respiratory Journal 2004;24(Suppl 48):291s.
  • Hunjan MK, Williams DT. Salmeterol/fluticasone propionate combination is clinically effective in avoiding exacerbations in patients with moderate/severe COPD [Abstract]. European Respiratory Journal 2004;24(Suppl 48):513s.
  • Jones PW, Edin HM, Anderson J. Salmeterol/fluticasone propionate combination improves health status in COPD patients. American Journal of Respiratory and Critical Care Medicine 2002;165(Suppl 8):A111.
  • Khamis RYRRK, Khamis RY, Rajakulasingam RK. Combined salmeterol and fluticasone for COPD. Lancet 2003;361(9369):1652; author reply 1652-3.
  • Nitschmann S. Inhalational combination therapy in chronic obstructive lung disease. Tristan study. German Internist 2004;45(6):727-8.
  • Pauwels RA, Calverley PMA, Vestbo J, Jones P, Pride NB, Gulsvik A, et al. Reduction of exacerbations with salmeterol/fluticasone combination 50/500mcg bd in the treatment of chronic obstructive pulmonary disease (COPD) [abstract]. European Respiratory Journal 2002;20 Suppl 38:240 [P1569].
  • Pauwels RA, Vestbo J, Calverley PA, Jones PW, Pride NB, Gulsvik A, et al. Characterization of exacerbations in the TRISTAN study of salmeterol/fluticasone propionate (SFC) combination in moderate to severe COPD [abstract]. American Thoracic Society 99th International Conference; May 16-21; Seattle. 2003:D092 Poster 215.
  • Spencer MD, Karia N, Anderson J. The clinical significance of treatment benefits with the salmeterol/fluticasone propionate 50/500mcg combination in COPD [Abstract]. European Respiratory Journal 2004;24(Suppl 48):290s.
  • Vestbo J, Calverley PMA, Pauwels R, Jones P, Pride NB, Gulsvik A, et al. Absence of JOURder susceptibility to the combination of salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease [abstract]. European Respiratory Journal 2002;20 Suppl 38:240 [P1570].
  • Vestbo J, Pauwels R, Anderson JA, Jones P, Calverley P, TRISTAN Study Group. Early onset of effect of salmeterol and fluticasone propionate in chronic obstructive pulmonary disease. Thorax 2005;60(4):301-4.
  • Vestbo J, Pauwels RA, Calverley PA, Jones PW, Pride NB, Gulsvik A, et al. Salmeterol/fluticasone propionate combination produces improvement in lung function detectable within 24 hours in moderate to severe COPD [abstract]. American Thoracic Society 99thInternational Conference; May 16-21; Seattle. 2003:A035 Poster D48.
  • Vestbo J, Soriano JB, Anderson JA, Calverley P, Pauwels R, Jones P, et al. Gender does not influence the response to the combination of salmeterol and fluticasone propionate in COPD. Respiratory Medicine 2004;98(11):1045-50.
Calverley 2003a {published data only}
  • AstraZeneca SD. A placebo-controlled 12-month efficacy study of the fixed combination budesonide/formoterol compared to budesonide and formoterol as monotherapies in patients with chronic obstructive pulmonary disease (COPD). http://www.astrazenecaclinicaltrials.com/ (accessed 6 March 2014).
  • Borgstrom L, Asking L, Olsson H, Peterson S. Lack of interaction between disease severity and therapeutic response with budesonide/formoterol in a single inhaler [Abstract]. American Thoracic Society 100th International Conference; May 21-26; Orlando. 2004:C22 [Poster 505].
  • Calverley PM, Boonsawat W, Cseke Z, Zhong N, Peterson S, Olsson H, et al. Maintenance therapy with budesonide and formoterol in chronic obstructive pulmonary disease. European Respiratory Journal 2003;22(6):912-9.
  • Calverley PM, Szafranski W, Calverley PMA, Andersson A. Budesonide/formoterol is a well-tolerated long term maintenance therapy for COPD [Abstract]. European Respiratory Journal 2005;26(Suppl 49):Abstract No. 1917.
  • Calverley PMA. Effect of Budesonide/Formoterol on severe exacerbations and lung function in moderate to severe COPD. Thorax 2002;57(Suppl III):iii44.
  • Calverley PMA, Olsson H, the Symbicort International CSG, Symbicort International CSG, Calverley PA, Symbicort International CG. Budesonide/formoterol in a single inhaler sustains improvements in lung function over 12 months compared with monocomponents and placebo in patients with COPD [abstract]. American Thoracic Society 99th International Conference; May 16-21; Seattle. 2003:B024 [Poster 418].
  • Calverley PMA, Peterson S. Combining budesonide/formoterol in a single inhaler reduces exacerbation frequency in COPD [abstract]. American Thoracic Society 99th International Conference; May 16-21; Seattle. 2003:D092 [Poster 211].
  • Calverley PMA, Sthal E, Jones PW, Ståhl E. Budesonide/formoterol improves the general health status of patients with COPD [Abstract]. American Thoracic Society International Conference; May 20-25; San Diego. 2005:B93 [Poster 303].
  • Calverley PMA, Thompson NC, Olsson H. Budesonide/formoterol in a single inhaler sustains lung function improvements in COPD [Abstract]. European Respiratory Journal 2003;22(Suppl 45):P435.
  • Calverly PMA, Cseke Z, Peterson S, Calverley PMA. Budesonide/formoterol reduces the use of oral corticosteroids in the treatment of COPD [Abstract]. European Respiratory Journal 2003;22 Suppl 45:Abstract No: [P436].
  • Calverly PMA, Kuna P, Olsson H, Calverley PMA. COPD exacerbations are reduced by budesonide/formoterol in a single inhaler [Abstract]. European Respiratory Journal 2003;22(Suppl 45):P1587.
  • Halpin D, Stahl E, Lundback B, Anderson F, Peterson S. Treatment costs and number needed to treat (NNT) with budesonide/formoterol to avoid one exacerbation of COPD [Abstract]. American Thoracic Society 100th International conference, May 21-26, 2004, Orlando. 2004:D22 [Poster 525].
  • Halpin DMG, Larsson T, Calverley PMA. How many patients with COPD must be treated with budesonide/formoterol compared with formoterol alone to avoid 1 day of oral steroid use? [Abstract]. American Thoracic Society 2005 International Conference; May 20-25; San Diego. 2005:[B93] [Poster: 314].
  • Jones PW, Stahl E. Budesonide/formoterol in a single inhaler improves health status in patients with COPD [abstract]. American Thoracic Society 99th International Conference; May 16-21, 2003; Orlando. 2003:B024 [Poster 419].
  • Jones PWSE, Jones PW, Ståhl E, Stahl E. Budesonide /formoterol sustains clinically relevant improvements in health status in COPD [Abstract]. European Respiratory Journal 2005;26(Suppl 49):Abstract No. 1352.
  • Lofdahl CG. Reducing the impact of COPD exacerbations: clinical efficacy of budesonide/formoterol. European Respiratory Review 2004;13(88):14-21.
  • Lofdahl CG, Andreasson E, Svensson K, Ericsson A. Budesonide/formoterol in a single inhaler improves overall health status in patients with COPD without increasing healthcare costs [abstract]. American Thoracic Society 99th International Conference; May 16-21; Seattle. 2003:A035 Poster D46.
  • Lofdahl CG, Andreassson E, Svensson K, Ericsson A, Andreasson E. Budesonide/formoterol in a single inhaler improves health status in patients with COPD without increasing healthcare costs [Abstract]. European Respiratory Journal 2003;22(Suppl 45):P433.
  • Lofdahl CG, Ericsson A, Svensson K, Andreasson E. Cost effectiveness of budesonide/formoterol in a single inhaler for COPD compared with each monocomponent used alone. PharmacoEconomics 2005;23(4):365-75.
Calverley 2003b {published data only}
  • Calverley P, Pauwels R, Nieminem M, Stryszak P, Staudinger H, Lee T. Once daily mometasone furoate dry powder inhaler preserves lung function, reduces symptoms and delays exacerbations in patients with COPD previously maintained on ICS [Abstract]. European Respiratory Journal 2003;22(Suppl 45):Abstract No: [155].
Calverley 2007 [TORCH] {published data only}
  • Allegra L. TORCH study: an invitation to clinical considerations. Giornale Italiano delle Malattie del Torace 2007;61(1):15-23.
  • Briggs AH, Glick HA, Lozano-Ortega G, Spencer M, Calverley PM, Jones PW, et al. Is treatment with ICS and LABA cost-effective for COPD? Multinational economic analysis of the TORCH study. European Respiratory Journal 2010;35(3):532-9.
  • Briggs AH, Lozano-Ortega G, Spencer S, Bale G, Spencer MD, Burge PS. Estimating the cost-effectiveness of fluticasone propionate for treating chronic obstructive pulmonary disease in the presence of missing data. Value in Health 2006;9(4):227-35. [CRS-ID: 4900100000020068]
  • Calverley P, Celli B, Anderson J, Ferguson G, Jenkins C, Jones P, et al. Salmeterol/fluticasone propionate combination (SFC) improves survival in COPD over three years: on-treatment analysis from the TORCH study [Abstract]. American Thoracic Society International Conference; May 15-20; San Diego. 2009:A6191[Poster #219].
  • Calverley P, Celli B, Anderson JA, Ferguson GT, Jenkins C, Jones PW, et al. The TOwards a Revolution in COPD Health (TORCH) study: salmeterol/fluticasone propionate improves survival in COPD over three years [Abstract]. Respirology 2006;11(Suppll 5):A149 [PS-3-8].
  • Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW, et al. Cardiovascular events in patients with chronic obstructive pulmonary disease: TORCH study results. Thorax 2010;65(8):719-25.
  • Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW, et al. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. New England Journal of Medicine 2007;356(8):775-89.
  • Calverley PM, Celli B, Anderson JA, Ferguson GT, Jenkins C, Jones PW, et al. The towards a revolution in COPD health (TORCH) study: fluticasone propionate/salmeterol improves survival in COPD over three years [Abstract]. Chest 2006;130(4):122s.
  • Calverley PMA, Celli B, Andersen JA, Ferguson GT, Jenkins C, Jones PW, et al. The TORCH (towards a revolution in COPD health) study: salmeterol/fluticasone propionate (SFC) improves health status reduces exacerbations and improves lung function over three years [Abstract]. European Respiratory Journal 2006;28(Suppl 50):34s [E311].
  • Calverley PMA, Celli B, Ferguson G, Jenkins C, Jones P, Pride NB, et al. Baseline characteristics of the first 5,000 COPD patients enrolled in the TORCH survival study. European Respiratory Journal 2003;22(Suppl 45):578s. [CRS-ID: 4900100000023124]
  • Celli B, Calverley PM, Anderson JA, Ferguson GT, Jenkins C, Jones P, et al. The TOwards a Revolution in COPD HEalth (TORCH) study: salmeterol/fluticasone propionate reduces the rate of exacerbations over three years [Abstract]. Respirology 2006;11(Suppl 5):A140 [O-9-2].
  • Celli B, Calverley PM, Anderson JA, Ferguson GT, Jenkins C, Jones PW, et al. The towards a revolution in COPD health (TORCH) study: fluticasone propionate/salmeterol reduces the rate of exacerbations over 3 years [Abstract]. Chest 2006;130(4):177s.
  • Celli B, Calverley PMA, Anderson JA, Ferguson GT, Jenkins C, Jones PW, et al. The TORCH (towards a revolution in COPD health) study: salmeterol/fluticasone propionate (SFC) improves health status, reduces exacerbations and improves lung function over three years [Abstract]. European Respiratory Journal 2006;28(Suppl 50):34s [E312].
  • Celli B, Emmett A, Crater G, Kalberg C. Fluticasone propionate/salmeterol (FSC) improves the inspiratory to total lung capacity ratio (IC/TLC) and exercise endurance time in patients with COPD [Abstract]. American Thoracic Society International Conference; May 19-21; San Diego. 2006:A320 [Poster 323].
  • Celli B, Emmett A, Crater G, Kalberg C, Celli D. Salmeterol/fluticasone propionate (SFC) improves the inspiratory to total lung capacity ratio (IC/TLC) and exercise endurance time in patients with COPD [Abstract]. European Respiratory Journal 2006;28(Suppl 50):764s [4395].
  • Celli B, Ferguson GT, Anderson JA, Jenkins CR, Jones PW, Vestbo J, et al. Salmeterol/fluticasone propionate (SFC) improves lung function and reduces the rate of decline over three years in the TORCH survival study [Abstract]. American Thoracic Society International Conference; May 18-23; San Francisco. San Francisco, California, USA, 2007:[A763].
  • Celli B, Vestbo J, Jenkins CR, Jones PW, Ferguson GT, Calverley PM, et al. Sex differences in mortality and clinical expressions of patients with chronic obstructive pulmonary disease. The TORCH experience. American Journal of Respiratory and Critical Care Medicine 2011;183(3):317-22.
  • Celli BR, Thomas NE, Anderson JA, Ferguson GT, Jenkins CR, Jones PW, et al. Effect of pharmacotherapy on rate of decline of lung function in chronic obstructive pulmonary disease: results from the TORCH study. American Journal of Respiratory and Critical Care Medicine 2008;178(4):332-8.
  • Corhay JL, Louis R. [Clinical study of the month: the TORCH study (TOwards a Revolution in COPD Health)]. [French]. Revue Medicale de Liege 2007;62(4):230-4.
  • Crim C, Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, et al. Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results. European Respiratory Journal 2009;34(3):641-7.
  • Ferguson GT, Calverley PM, Anderson JA, Celli B, Jenkins C, Jones PW, et al. The towards a revolution in COPD health (TORCH) study: fluticasone propionate/salmeterol is well tolerated in patients with COPD over 3 years [Abstract]. Chest 2006;130(4):178s.
  • Ferguson GT, Calverley PM, Anderson JA, Celli B, Jenkins CR, Jones PW, et al. Effect of salmeterol/fluticasone propionate (SFC) on bone mineral density (BMD) and eye disorders over three years in the TORCH trial [Abstract]. American Thoracic Society International Conference, May 18-23, San Francisco. San Francisco, California, USA, 2007:[A763].
  • Ferguson GT, Calverley PM, Anderson JA, Jenkins CR, Jones PW, Willits LR, et al. Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study. Chest 2009;136(6):1456-65.
  • GlaxoSmithKline. A multi-centre, randomised, double-blind, parallel group study to investigate the efficacy and safety of the salmeterol/fluticasone propionate combination at a strength of 50/500 µg BD, compared with placebo via Accuhaler, added to usual chronic obstructive pulmonary disease (COPD) therapy, in subjects with COPD for 24 weeks [SCO100540]. http://www.gsk-clinicalstudyregister.com/study/100540?study_ids=SCO100540#rs (accessed 3 March 2014).
  • GlaxoSmithKline. A multicentre, randomised, double-blind, parallel group, placebo-controlled study to compare the efficacy and safety of the salmeterol/FP combination product at a strength of 50/500mcg bd with salmeterol 50mcg bd alone and FP 500mcg bd alone, delivered via the DISKUS Accuhaler, in the treatment of subjects with chronic obstructive pulmonary disease (COPD) for 12 months. SFCB3024. http://www.gsk-clinicalstudyregister.com/ (accessed 3 March 2014). [CRS-ID: 4900100000078008]
  • GlaxoSmithKline. A multicentre, randomised, double-blind, parallel group, placebo-controlled study to investigate the long-term effects of salmeterol/fluticasone propionate (SERETIDE®/VIANI®/ADVAIR®) 50/500 mcg bd, salmeterol 50 mcg bd and fluticasone propionate 500 mcg bd, all delivered via the DISKUS®/ACCUHALER® inhaler, on the survival of subjects with chronic obstructive pulmonary disease (COPD) over 3 years of treatment. http://www.gsk-clinicalstudyregister.com/ (accessed 3 March 2014).
  • Glick H, Briggs A, Lozano-Ortega G, Spencer M, Vestbo J, Calverley P. Is treatment with ICS/LABA combination good value for money in COPD? Evidence from the TORCH study [Abstract]. American Thoracic Society International Conference; May 18-23; San Francisco. 2007:[C97].
  • Houghton CM, Lawson N, Borrill ZL, Wixon CL, Yoxall S, Langley SJ, et al. Comparison of the effects of salmeterol/fluticasone propionate with fluticasone propionate on airway physiology in adults with mild persistent asthma. Respiratory Research 2007;8:52. [CRS-ID: 4900102000000754]
  • Jenkins C, Celli B, Anderson J, Ferguson G, Calverley P, Jones P, et al. Salmeterol/fluticasone propionate (SFC) is efficacious in GOLD stage II COPD patients: analysis from the TORCH study [Abstract]. American Thoracic Society International Conference; May 15-20; San Diego. 2009:A6186 [Poster #213].
  • Jenkins CR, Calverley PMA, Celli B, Ferguson G, Jones PW, Pride N, et al. Seasonal patterns of exacerbation rates in the TORCH survival study [Abstract]. American Thoracic Society International Conference; May 19-24; San Diego. 2006:A839 [Poster 603]. [CRS-ID: 4900100000020491]
  • Jenkins CR, Celli B, Anderson JA, Ferguson GT, Jones PW, Vestbo J, et al. Seasonality and determinants of moderate and severe COPD exacerbations in the TORCH study. European Respiratory Journal 2012;39(1):38-45.
  • Jenkins CR, Celli B, Anderson JA, Ferguson GT, Jones PW, Vestbo J, et al. The TORCH survival study: consistent efficacy results seen in geographic regions in a multi-national study [Abstract]. American Thoracic Society International Conference; May 18-23; San Francisco. 2007:[C97].
  • Jenkins CR, Jones PW, Calverley PM, Celli B, Anderson JA, Ferguson GT, et al. Efficacy of salmeterol/fluticasone propionate by GOLD stage of chronic obstructive pulmonary disease: analysis from the randomised, placebo-controlled TORCH study. Respiratory Research 2009;10:59.
  • Johnson M, Agusti AG, Barnes NC. Reflections on TORCH: potential mechanisms for the survival benefit of salmeterol/fluticasone propionate in COPD patients. COPD 2008;5(6):369-75.
  • Jones P, Calverley P, Celli B, Ferguson G, Jenkins C, Pride N, et al. Trans-regional validity of the SGRQ in the TORCH survival study [Abstract]. American Thoracic Society International Conference; May 19-21; San Diego. 2006:A122 [Poster J79]. [CRS-ID: 4900100000020810]
  • Jones PW, Anderson JA, Calverley PM, Celli BR, Ferguson GT, Jenkins C, et al. Health status in the TORCH study of COPD: treatment efficacy and other determinants of change. Respiratory Research 2011;12:71.
  • Jones PW, Calverley P, Celli B, Ferguson G, Jenkins C, Pride N. Trans-regional validity of the SGRQ in the TORCH survival study. American Thoracic Society International Conference; May 19-24; San Diego. 2006:A122, Poster J79. [CRS-ID: 4900100000061615]
  • Jones PW, Calverley PM, Celli B, Anderson JA, Ferguson GT, Jenkins C, et al. The towards study a revolution in COPD health (TORCH) study: fluticasone propionate/salmeterol improves and sustains health status in COPD over 3 years [Abstract]. Chest 2006;130(4):177s.
  • Jones PW, Vestbo J, Anderson JACB, Ferguson GT, Jenkins CR, Yates JC, et al. Informative withdrawal in a COPD study. An example from the TORCH Study [Abstract]. American Thoracic Society International Conference; May 18-23; San Francisco. 2007:[C97].
  • Keene ON, Vestbo J, Anderson JA, Calverley PMA, Celli B, Ferguson GT, et al. Methods for therapeutic trials in COPD: lessons from the TORCH trial. European Respiratory Journal 2009;34(5):1018-23.
  • McDonough C, Blanchard AR. TORCH study results: pharmacotherapy reduces lung function decline in patients with chronic obstructive pulmonary disease. Hospital Practice (1995) 2010;38(2):92-3.
  • McGarvey LP, John M, Anderson JA, Zvarich M, Wise RA, Committee TCE, et al. Ascertainment of cause-specific mortality in COPD: operations of the TORCH Clinical Endpoint Committee. Thorax 2007;62(5):411-5.
  • Mehta RS, Kathman SJ, Daley-Yates PT, Cahn T, Beerahee M, Kunka RL, et al. Pharmacokinetics and pharmacodynamics in COPD patients following long-term twice-daily treatment with salmeterol/fluticasone propionate (SFC) 50/500mg and the individual components [Abstract]. American Thoracic Society International Conference; May 18-23; San Francisco. San Francisco, California, USA, 2007:Poster #A41.
  • NCT. A multicenter, randomized, double-blind, parallel group, placebo controlled study to investigate the effects of salmeterol/fluticasone 50/500mcg bd, salmeterol 50mcg bd, and fluticasone 500mcg bd, all delivered via the DISKUS/ACCUHALER inhaler, on the survival of subjects with chronic obstructive pulmonary disease over 3 years of treatment. ClinicalTrials.gov 2000.
  • NCT00268216. Survival of subjects with chronic obstructive pulmonary disease (COPD). http://clinicaltrials.gov/show/NCT00268216 (accessed 3 March 2014). [CRS-ID: 4900100000080627]
  • SCO30003. A multicentre, randomised, double-blind, parallel group, placebo-controlled study to investigate the long-term effects of salmeterol/fluticasone propionate (SERETIDE ADVAIR®) 50/500mcg bd, salmeterol 50mcg bd and fluticasone propionate 500mcg bd, all delivered via the DISKUS®/ACCUHALER® inhaler, on the survival of subjects with chronic obstructive pulmonary disease (COPD) over 3 years of treatment. http://www.gsk-clinicalstudyregister.com/study/SCO30003#ps (accessed 3 March 2014). [CRS-ID: 4900100000033585]
  • Sacchetta A. Long term therapy and outcome of chronic obstructive pulmonary disease with or without co-morbidity: the TORCH study. Italian Journal of Medicine 2008;2(3):11-5.
  • Vestbo J, Anderson JA, Calverley PM, Celli B, Ferguson GT, Jenkins C, et al. Adherence to inhaled therapy, mortality and hospital admission in COPD. Thorax 2009;64(11):939-43.
  • Vestbo J, Anderson JA, Calverley PMA, Celli B, Ferguson GT, Jenkins C, et al. Bias due to withdrawal in long-term randomised trials in COPD: evidence from the TORCH study. Clinical Respiratory Journal 2011;5(1):44-9.
  • Vestbo J, TORCH SG, Calverley P, Celli B, Ferguson G, Jenkins C, et al. The TORCH (towards a revolution in COPD health) survival study protocol. European Respiratory Journal 2004;24(2):206-10. [CRS-ID: 4900100000017206]
  • Wise RA, McGarvey LP, John M, Anderson JA, Zvarich MT. Reliability of cause-specific mortality adjudication in a COPD clinical trial. American Thoracic Society International Conference; May 18-23; San Francisco. 2007:A120. [CRS-ID: 4900100000080628]
  • Wise RA, McGarvey LP, John M, Anderson JA, Zvarich MT, Anderson JA, et al. Reliability of cause specific mortality adjudication in a COPD clinical trial [Abstract]. American Thoracic Society International Conference; May 19-21; San Diego. 2006:A120 [Poster J68]. [CRS-ID: 4900100000020230]
Calverley 2008 {published data only}
  • Calverley PM, Rennard S, Nelson HS, Karpel JP, Abbate EH, Stryszak P, et al. One-year treatment with mometasone furoate in chronic obstructive pulmonary disease. Respiratory Research 2008;9:73.
  • Nelson H, Karpel JP, Staudinger H, Busse WW. Mometasone furoate dry powder inhaler (MF-DPI) improves FEV1, symptoms, and quality of life and reduces exacerbations in patients with COPD [Abstract]. Chest 2004;126(4 Suppl):709S-c, 710.
Calverley 2010 {published data only}
  • Calverley PMA, Kuna P, Monsó E, Costantini M, Petruzzelli S, Sergio F, et al. Beclomethasone/formoterol in the management of COPD: a randomised controlled trial. Respiratory Medicine 2010;104(12):1858-68.
Campbell 2005 {published data only}
  • AstraZeneca. A 6-month study to compare the efficacy and safety of 9microg formoterol (Oxis) Turbuhaler b.i.d. with placebo b.i.d. in patients with chronic obstructive pulmonary disease (COPD). Furthermore to compare formoterol 4.5microg as needed with terbutaline 0.5 mg as needed. SD-037-0709. http://www.astrazenecaclinicaltrials.com/ (accessed 12 December 2012).
  • Bogdan M, Eliraz A, McKinnon C, Nihlen U, Radeczky E, Soliman S, et al. Formoterol turbuhaler is an effective maintenance and maintenance plus reliever therapy in patients with chronic obstructive pulmonary disease (COPD) irrespective of the level of lung function impairment and reversibility [abstract]. European Respiratory Society 12th Annual Congress; Sep 14-18; Stockholm. 2002:abstract nr: P1578.
  • Campbell M, Eliraz A, Johansson G, Tornling G, Nihlén U, Bengtsson T, et al. Formoterol for maintenance and as-needed treatment of chronic obstructive pulmonary disease. Respiratory Medicine 2005;99(12):1511-20.
  • Campbell M, Rabe KF, Andersson A. Formoterol turbuhaler for maintenance and as-needed use is effective and well tolerated in patients with COPD [abstract]. American Thoracic Society 99th International Conference; May 16-21; Seattle. 2003:B024 Poster 417.
  • Eliraz A, Bengtsson T, Bogdan M, Coenen PDM, Johanson G, Osmanilev D, et al. Formoterol turbuhaler is effective and safe as maintenance or maintenance plus reliever therapy in patients with chronic obstructive pulmonary disease (COPD) [abstract]. European Respiratory Society 12th Annual Congress; Sep 14-18; Stockholm. 2002:abstract nr: P1580.
Casaburi 2002 {published data only}
  • Adams SG, Anzueto A, Briggs DD, Menjoge SS, Kesten S. Tiotropium in COPD patients not previously receiving maintenance respiratory medications. Respiratory Medicine 2006;100(9):1495-503.
  • Anzueto A, Kesten S. Effects of tiotropium in COPD patients only treated with PRN albuterol [Abstract]. American Thoracic Society 100th International Conference; May 21-26; Orlando. 2004:C47 Poster F81.
  • Anzueto A, Tashkin D, Menjoge S, Kesten S. One-year analysis of longitudinal changes in spirometry in patients with COPD receiving tiotropium. Pulmonary Pharmacology & Therapeutics 2005;18(2):75-81.
  • Casaburi R, Mahler DA, Jones PW, Wanner A, San PG, ZuWallack RL, et al. A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. European Respiratory Journal 2002;19(2):217-24.
  • Friedman M, Bell T, Menjoge SS, Anton S, Koch P. Cost consequences of tiotropium plus existing therapy versus existing therapy alone following one year of treatment in patients with COPD. European Respiratory Journal 2001;18(Suppl 33):5s.
  • Kesten S, Menjoge S. Can patient demographics be used to predict future choices for antibiotics, steroids, or both for exacerbations of COPD? [Abstract]. National COPD conference; November 14-15; Arlington, Virginia. 2003:Abstract no: 1189.
  • Mahler DA, Montner P, Brazinsky SA, Goodwin B, Menjoge SS, Witek TJ. Tiotropium (Spiriva), a new long-acting anticholinergic bronchodilator, improves dyspnea in patients with COPD [abstract]. American Journal of Respiratory and Critical Care Medicine 2000;161(3 Suppl):A892.
  • Rutten-van Mölken MP, Oostenbrink JB, Miravitlles M, Monz BU. Modelling the 5-year cost effectiveness of tiotropium, salmeterol and ipratropium for the treatment of chronic obstructive pulmonary disease in Spain. European Journal of Health Economics 2007;8(2):123-35.
  • Serby CW. Impact of tiotropium on COPD exacerbations: 1-Yr studies versus placebo or ipratropium. European Respiratory Review 2002;12(82):16-7.
  • Spencer S. Decline in health status over one year is eliminated by tiotropium. American Journal of Respiratory and Critical Care Medicine 2002;165(Suppl 8):A228.
  • Spencer SJPW, Spencer S, Jones PW. Short-term changes in health status with tiotropium predict long-term changes in health status [abstract]. European Respiratory Society 12th Annual Congress; Sep 14-18; Stockholm. 2002:abstract nr: P1611.
  • Tashkin D, Kesten S. Long-term treatment benefits with tiotropium in COPD patients with and without short-term bronchodilator responses. Chest 2003;123(5):1441-9.
  • Zu Wallack R, Jones PW, Kotch A, Goodwin B, Menjoge SS, Serby CW, et al. Tiotropium (Spiriva) improves health status in patients with COPD [abstract]. American Journal of Respiratory and Critical Care Medicine 2000;161(3 Suppl):A892.
Chan 2007 {published data only}
  • Chan CK, Maltais F, Sigouin C, Haddon JM, Ford GT, Group SS, et al. A randomized controlled trial to assess the efficacy of tiotropium in Canadian patients with chronic obstructive pulmonary disease. Canadian Respiratory Journal [Revue canadienne de pneumologie] 2007;14(8):465-72.
Cooper 2010 {published data only}
  • Cooper CB, Abrazado M, Legg D, Kesten S. Development and implementation of treadmill exercise testing protocols in COPD. International Journal of Chronic Obstructive Pulmonary Disease 2010;5:375-85.
  • Cooper CB, Celli B, Wise RA, Jardim JR, Legg D, Guo J, et al. 'Treadmill endurance during 2 years' treatment with tiotropium in patients with COPD [Abstract]. American Journal of Respiratory and Critical Care Medicine 2011;183(Meeting Abstracts):A4586.
  • Cooper CB, Celli BR, Wise R, de Brito Jardim JR, Guo J, et al. Relationship between quality of life and exercise endurance in a long-term study of tiotropium in COPD patients [Abstract]. American Journal of Respiratory and Critical Care Medicine 2012;185(Meeting Abstracts):A1534.
Dahl 2010 {published data only}
  • Buhl R, Pieters W, Jack D, Owen R, Kramer B, Higgins M. Indacaterol once-daily improves dyspnoea and BODE index in COPD patients: a 52-week study [Abstract]. European Respiratory Society Annual Congress; Sep 12-15; Vienna. 2009:[P2026].
  • Buhl R, Pieters W, Jack D, Owen R, Kramer B, Higgins M. Indacaterol once-daily reduces COPD exacerbations over 52 weeks of treatment [Abstract]. American Thoracic Society International Conference; May 15-20; San Diego. 2009:A6185 [Poster #212].
  • Chung F, Kornmann O, Jack D, Owen R, Kramer B, Higgins M. Safety and tolerability of indacaterol over 52 weeks of treatment in COPD [Abstract]. European Respiratory Society 19th Annual Congress; Sep 12-15; Vienna. 2009:[E4359].
  • Chung KF, Kornmann O, Jack D, Owen R, Kramer B, Higgins M, et al. Safety and tolerability of indacaterol over 52 weeks of treatment in COPD [Abstract]. European Respiratory Society 19th Annual Congress; Sep 12-15; Vienna. 2009:A4546 [Poster #J56].
  • Dahl R, Chung KF, Buhl R, Magnussen H, Nonikov V, Jack D, et al. Efficacy of a new once-daily long-acting inhaled beta2-agonist indacaterol versus twice-daily formoterol in COPD. Thorax 2010;65(6):473-9.
  • Dahl R, Kolman P, Jack D, Bleasdale P, Owen R, Higgins M, et al. Bronchodilator therapy with indacaterol once-daily in COPD: a 52-week comparison with formoterol [Abstract]. European Respiratory Society 19th Annual Congress; Sep 12-15; Vienna. 2009:[E4350].
  • Dahl R, Kolman P, Jack D, Owen R, Kramer B, Higgins M. Indacaterol once-daily provides sustained 24-h bronchodilation over 52 weeks of treatment in COPD [Abstract]. American Thoracic Society International Conference; May 15-20; San Diego. 2009:A4545 [Poster #J55].
  • Magnussen H, Paggiaro P, Jack D, Owen R, Higgins M, Kramer B, et al. Bronchodilator treatment with indacaterol once-daily vs formoterol twice-daily in COPD: a 52-week study [Abstract]. American Thoracic Society International Conference; May 15-20 San Diego. 2009:A6184 [Poster #211].
  • Magnussen H, Verkindre C, Jack D, Jadayel D, Owen R, Higgins M, et al. Indacaterol once-daily is equally effective dosed either in the evening or morning in COPD patients [Abstract]. European Respiratory Society 19th Annual Congress; Sep 12-15; Vienna. 2009:[E4361].
  • Nonikov V, Verkindre C, Jack D, Bleasdale P, Owen R, Kramer B, et al. Indacaterol once-daily improves symptom control in COPD patients: a 52-week evaluation vs placebo (pbo) and formoterol (for) [Abstract]. European Respiratory Society 19th Annual Congress; Sep 12-15; Vienna. 2009:[P2024].
  • Nonikov V, Verkindre C, Jack D, Owen R, Higgins M, Kramer B. Indacaterol once-daily reduces days of poor control in COPD over 52 weeks of treatment [Abstract]. American Thoracic Society International Conference; May 15-20 San Diego. 2009:A6190 [Poster #218].
Dal Negro 2003 {published data only}
  • Dal Negro R, Micheletto C, Trevison F, Tognells S, Pomari C, Spencer S, et al. Salmeterol & fluticasone 50 µg/250 µg bid vs salmeterol 50 µg bid and vs placebo in the long-term treatment of COPD. American Journal of Respiratory and Critical Care Medicine 2002;165(Suppl 8):A228.
  • Dal Negro RW, Pomari C, Tognella S, Micheletto C, Dal Negro R. Salmeterol & fluticasone 50 microg/250 microg bid in combination provides a better long-term control than salmeterol 50 microg bid alone and placebo in COPD patients already treated with theophylline. Pulmonary Pharmacology and Therapeutics 2003;16(4):241-6.
Doherty 2012 {published data only}
  • Doherty D, Tashkin D, Kerwin E, Eduardo Matiz-Bueno C, Shekar T, Banerjee S, et al. Efficacy and safety of mometasone furoate/formoterol in subjects with moderate to very severe chronic obstructive pulmonary disease: results from two phase three 26-week trials [Abstract]. Chest 2011;140(4):535A.
  • Doherty DE, Kerwin E, Tashkin DP, Matiz-Bueno CE, Shekar T, Banerjee S, et al. Combined mometasone furoate and formoterol in patients with moderate to very severe chronic obstructive pulmonary disease (COPD): phase 3 efficacy and safety study [Abstract]. Journal of Allergy and Clinical Immunology 2012;129(2 Suppl):AB75 [283].
  • Doherty DE, Tashkin DP, Kerwin E, Knorr BA, Shekar T, Banerjee S, et al. Effects of mometasone furoate/formoterol fumarate fixed-dose combination formulation on chronic obstructive pulmonary disease (COPD): results from a 52-week Phase III trial in subjects with moderate-to-very severe COPD. International Journal of Chronic Obstructive Pulmonary Disease 2012;7:57-71.
  • Kerwin E, Tashkin D, Matiz-Bueno CE, Doherty D, Shekar T, Banerjee S, et al. Quality of life following 26 weeks of mometasone furoate/formoterol therapy: results from two phase three trials in subjects with moderate to very severe chronic obstructive pulmonary disease [Abstract]. Chest 2011;140(4):558A.
  • Matiz-Bueno CE, Doherty D, Kerwin E, Tashkin D, Shekar T, Banerjee S, et al. The long-term safety characteristics of mometasone furoate/formoterol for the treatment of moderate to very severe chronic obstructive pulmonary disease: pooled findings from two 1-year multicenter clinical trials [Abstract]. Chest 2011;140(4):548A.
  • Tashkin D, Doherty D, Kerwin E, Matiz-Bueno CE, Shekar T, Banerjee S, et al. The effect of mometasone furoate/formoterol combination therapy on chronic obstructive pulmonary disease (COPD) exacerbations: results from two phase three trials in subjects with moderate to very severe COPD [Abstract]. Chest 2011;140(4):549A.
  • Tashkin DP, Doherty DE, Kerwin E, Matiz-Bueno CE, Knorr B, Shekar T, et al. Efficacy and safety characteristics of mometasone furoate/formoterol fumarate fixed-dose combination in subjects with moderate to very severe COPD: findings from pooled analysis of two randomized, 52-week placebo-controlled trials. International Journal of COPD 2012;7:73-86.
Donohue 2010 [INHANCE] {published data only}
  • Barnes PJ, Pocock SJ, Magnussen H, Iqbal A, Kramer B, Higgins M, et al. Indacaterol dose selection: utilising an adaptive seamless design in a clinical study in COPD [Abstract]. European Respiratory Society 19th Annual Congress; Sep 12-15; Vienna. 2009:[E4358].
  • Barnes PJ, Pocock SJ, Magnussen H, Iqbal A, Kramer B, Higgins M, et al. Integrating indacaterol dose selection in a clinical study in COPD using an adaptive seamless design. Pulmonary Pharmacology and Therapeutics 2010;23(3):165-71.
  • Barnes PJ, Pocock SJ, Magnussen H, Iqbal A, Lawrence D, Kramer B, et al. Integrating indacaterol dose selection in a clinical study in COPD using an adaptive seamless design [Abstract]. American Thoracic Society International conference, May 15-20, San Diego. 2009:A4543 [Poster #J53].
  • Chapman KR, Rennard SI, Dogra A, Owen R, Lassen C, Kramer B. Long-term safety and efficacy of indacaterol, a long-acting beta2-agonist, in subjects with COPD: a randomized, placebo-controlled study. Chest 2011;140(1):68-75.
  • Donohue JF, Fogarty C, Lotvall J, Mahler DA, Worth H, Yorgancioglu A, et al. Once-daily bronchodilators for chronic obstructive pulmonary disease: indacaterol versus tiotropium. American Journal of Respiratory and Critical Care Medicine 2010;182(2):155-62.
  • Fogarty C, Hebert J, Iqbal A, Owen R, Higgins M, Kramer B. Indacaterol once-daily provides effective 24-h bronchodilation in COPD patients: a 26-week evaluation vs placebo and tiotropium [Abstract]. European Respiratory Society 19th Annual Congress; Sep 12-15; Vienna. 2009:[P2025].
  • Fogarty C, Worth H, Herbert J, Iqbal A, Owen R, Higgins M, et al. Sustained 24-h bronchodilation with indacaterol once-daily in COPD: a 26-week efficacy and safety study [Abstract]. American Thoracic Society International Conference; May 15-20 San Diego. 2009:A4547 [Poster #J57].
  • Jones PW, Mahler DA, Gale R, Owen R, Kramer B. Profiling the effects of indacaterol on dyspnoea and health status in patients with COPD. Respiratory Medicine 2011;105(6):892-9.
  • Lotvall J, Cosio BG, Iqbal A, Swales J, Owen R, Kramer B, et al. Indacaterol once-daily improves day and night-time symptom control in COPD patients: a 26-week study versus placebo and tiotropium [Abstract]. European Respiratory Society 19th Annual Congress; Sep 12-15; Vienna. 2009:[P2029].
  • Mahler D, Palange P, Iqbal A, Owen R, Higgins M, Kramer B. Indacaterol once-daily improves dyspnoea in COPD patients: a 26-week placebo-controlled study with open-label tiotropium comparison [Abstract]. European Respiratory Society 19th Annual Congress; Sep 12-15; Vienna. 2009:[E4360].
  • Rennard S, Bantje T, Centanni S, Chanez P, Chuchalin A, D'Urzo A, et al. A dose-ranging study of indacaterol in obstructive airways disease, with a tiotropium comparison. Respiratory Medicine 2008;102(7):1033-44.
  • Rennard SI, Chapman KR, Luthra A, Swales J, Lassen C, Owen R, et al. Once-daily indacaterol provides effective bronchodilation over 1 year of treatment in patients with chronic obstructive pulmonary disease (COPD) [Abstract]. Chest 2009;136(4):4S-f.
  • Worth H, Kleerup E, Iqbal A, Owen R, Kramer B, Higgins M. Safety and tolerability of indacaterol once-daily in COPD patients versus placebo and tiotropium: a 26-week study [Abstract]. European Respiratory Society 19th Annual Congress; Sep 12-15; Vienna. 2009:[P2030].
  • Yorgancioglu A, Mahler D, Iqbal A, Owen R, Higgins M, Kramer B. Indacaterol once-daily improves health-related quality of life in COPD patients: a 26 -week comparison with placebo and tiotropium [Abstract]. European Respiratory Society 19th Annual Congress; Sep 12-15; Vienna. 2009:[P2028].
Dusser 2006 {published data only}
  • Dusser D, Bravo ML, Iacono P, Lacono P. The effect of tiotropium on exacerbations and airflow in patients with COPD. European Respiratory Journal 2006;27(3):547-55.
  • Dusser D, Bravo ML, Iacono P, Lacono P. Tiotropium reduces health resource utilization associated with COPD exacerbations [Abstract]. European Respiratory Journal 2004;24(Suppl 48):513s.
  • Dusser D, Bravo ML, Ianono P, Lanono P. Tiotropium COPD exacerbations the MISTRAL study [Abstract]. European Respiratory Journal 2004;24(Suppl 48):513s.
  • Dusser D, Viel K, Bravo ML, Iacono P. Tiotropium reduces moderate-to-severe exacerbations in COPD patients irrespective of concomitant use of inhaled corticosteroids (ICS) [Abstract]. American Thoracic Society International Conference; May 19-21; San Diego. 2006:A603 [Poster H6].
  • Dusser D, Viel K, Rouyrre N, Iancono P. Tiotropium reduces COPD exacerbations requiring treatment with systemic corticosteroids, antibiotics, or hospitalizations [Abstract]. American Thoracic Society International Conference; May 19-21; San Diego. 2006:A603 [Poster H5].
Fang 2008 {published data only}
  • Fang LZ, Liang X, Zhang JQ, Liu L, Fu WP, Zhao ZH, et al. Combination of inhaled salmeterol/fluticasone and tiotropium in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial. Chung-Hua Chieh Ho Ho Hu Hsi Tsa Chih Chinese Journal of Tuberculosis & Respiratory Diseases 2008;31(11):811-4.
Ferguson 2008 {published data only}
  • Dalal AA, Blanchette CM, Petersen H, Manavi K, St. Charles M. Cost-effectiveness of fluticasone propionate/salmeterol (250/50 mcg) compared to salmeterol (50 mcg) in patients with COPD: economic evaluation of a randomized, double-blind, parallel-group, multicenter trial (Study SCO40043) [Abstract]. Chest 2008;134(4):106003s.
  • Dalal AA, St Charles M, Petersen HV, Roberts MH, Blanchette CM, Manavi-Zieverink K. Cost-effectiveness of combination fluticasone propionate-salmeterol 250/50 microg versus salmeterol in severe COPD patients. International Journal of Chronic Obstructive Pulmonary Disease 2010;5:179-87.
  • Ferguson G, Anzueto A, Fei R, Emmett A, Crater G, Knobil K, et al. A randomized, double-blind trial comparing the effect of fluticasone/salmeterol 250/50 to salmeterol on COPD exacerbations in patients with COPD. Chest 2007;132(4):530b-531.
  • Ferguson GT, Anzueto A, Fei R, Emmett A, Knobil K, Kalberg C. Effect of fluticasone propionate/salmeterol (250/50 microg) or salmeterol (50 microg) on COPD exacerbations. Respiratory Medicine 2008;102(8):1099-108.
  • SCO40043 G. A randomized, double-blind, parallel-group, 52-week study to compare the effect of fluticasone propionate/salmeterol DISKUS ® 250/50mcg bid with salmeterol DISKUS ® 50mcg bid on the annual rate of moderate/severe exacerbations in subjects with chronic obstructive pulmonary disease (COPD). http://www.gsk-clinicalstudyregister.com/study/SCO40043#ps (accessed 3 March 2014). [CRS-ID: 4900100000033604]
FLTA3025 {published data only}
  • Eden HM, Price MJ, Jenkins R, Darken P, Horstman D. Fluticasone propionate improves quality of life in patients with COPD. American Journal of Respiratory and Critical Care Medicine 2001;163(5 Suppl):A643.
  • Rennard S, Bailey W, Tashkin D, Abrahams R, Horstman D, Ho S, et al. Improvements in airflow & dyspnea in COPD patients following BID treatment with fluticasone propionate (FP) 250mcg & 500mcg for 24 weeks via the diskus(r) inhaler [abstract]. American Journal of Respiratory and Critical Care Medicine 2001;163(5 Suppl):A279.
Gelb 2012 {published data only}
  • Gelb A, Tashkin D, Make B, Zhong X, Garcia Gil E, Caracta C. Long-term safety of twice-daily aclidinium bromide in COPD patients: a one-year, double-blind study [Abstract]. European Respiratory Society 22nd Annual Congress; Sep 1-5; Vienna. 2012; Vol. 40, issue Suppl 56:376s [P2118].
  • Gelb AF, Make BJ, Tashkin DP, Zhong X, Garcia GE, Caracta C. Long-term efficacy and safety of twice-daily aclidinium bromide in COPD patients: a one-year study [Abstract]. American Journal of Respiratory and Critical Care Medicine 2012;185(Meeting Abstracts):A2256.
  • Tashkin D, Gelb A, Make B, Zhong X, Garcia Gil E, Caracta C. Long-term efficacy of twice-daily aclidinium bromide in COPD patients: a one-year study [Abstract]. European Respiratory Society 22nd Annual Congress; Sep 1-5; Vienna. 2012; Vol. 40, issue Suppl 56:528s [P2893].
GLOW1 2011 {published data only}
  • D'Urzo A, Ferguson GT, van Noord JA, Hirata K, Martin C, Horton R, et al. Efficacy and safety of once-daily NVA237 in patients with moderate-to-severe COPD: the GLOW1 trial. Respiratory Research 2011;12:156.
  • D'Urzo A, Van Noord JA, Martin C, Horton R, Banerji D, Lu Y, et al. Once-daily NVA237 improves symptoms, and reduces COPD exacerbations and associated hospitalisations: the GLOW1 trial [Abstract]. Thorax 2011;66(Suppl 4):P252.
  • D'Urzo T, Ferguson G, Martin C, Alagappan VKT, Banerji D, Lu Y, et al. NVA237 once daily offers rapid and clinically meaningful bronchodilation in COPD patients that is maintained for 24 h: the GLOW1 trial [Abstract]. Thorax 2011;66(Suppl 4):P253.
  • D’Urzo A, Ferguson G, Kato M, Atis S, Martin C, Alagappan VKT, et al. NVA237 once daily provides rapid, clinically meaningful and sustained 24-h bronchodilation in patients with COPD: the GLOW1 trial [Abstract]. European Respiratory Society 21st Annual Congress; Sep 24-28; Amsterdam. 2011; Vol. 38, issue 55:147s [P866]. [GLOW1: NCT01005901]
  • D’Urzo A, Ferguson G, Martin C, Alagappan VKT, Banerji D, Lu Y, et al. NVA237 once daily offers rapid and clinically meaningful bronchodilation in COPD patients that is maintained for 24-hours: the GLOW1 trial [Abstract]. 6th IPCRG World Conference; Apr 25-28; Edinburgh. 2012:Abstract 133.
  • D’Urzo A, Ferguson G, Martin C, Lu Y, Banerji D, Overend T. NVA237 once daily reduces the percentage of patients with exacerbations of COPD and associated hospitalizations: the GLOW1 trial [Abstract]. European Respiratory Society 21st Annual Congress; Sep 24-28; Amsterdam. 2011; Vol. 38, issue 55:608s [3427].
  • D’Urzo A, van Noord JA, Martin C, Horton R, Banerji D, Lu Y, et al. Once-daily NVA237 improves symptoms, and reduces COPD exacerbations and associated hospitalisations: the GLOW1 trial [Abstract]. 6th IPCRG World Conference; Apr 25-28; Edinburgh. 2012:Abstract 134.
  • Kato M, D'Urzo A, Martin C, Banerji D, Lu Y, Overend T. NVA237 once daily improves symptoms and reduces exacerbations of COPD and associated hospitalizations: the GLOW1 trial [Abstract]. Respirology (Carlton, Vic.) 2011;16(Suppl 2):105 [634].
  • van Noord JA, Hirata K, D’Urzo A, Martin C, Horton R, Lu Y, et al. NVA237 once daily improves dyspnea and health-related quality of life (HRQoL) in patients with COPD: the GLOW1 trial [Abstract]. European Respiratory Society 21st Annual Congress; Sep 24-28; Amsterdam. 2011; Vol. 38, issue 55:148s [P867].
GLOW2 2012 {published data only}
  • Kerwin EM, Hebert J, Pedinoff A, Gallagher N, Martin C, Banerji D. NVA237 once daily provides rapid and sustained bronchodilation in COPD patients, with efficacy similar to tiotropium: the GLOW2 trial [Abstract]. American Journal of Respiratory and Critical Care Medicine 2012;185(Meeting Abstracts):A2920.
  • Kerwin EM, Pedinoff A, Casale TB, Gallagher N, Martin C, Banerji D. NVA237 once daily reduces COPD exacerbations with similar rates to tiotropium: the GLOW2 trial [Abstract]. American Journal of Respiratory and Critical Care Medicine 2012;185(Meeting Abstracts):A2255.
  • Korenblat PE, Hebert J, Gallagher N, Martin C, Banerji D, Lu Y. NVA237 once daily improves dyspnea and health-related quality of life in patients with COPD: the GLOW2 trial [Abstract]. American Journal of Respiratory and Critical Care Medicine 2012;185(Meeting Abstracts):A2254.
Hanania 2003 {published data only}
  • GlaxoSmithKline. A randomized, double-blind, placebo-controlled, parallel-group trial evaluating the safety and efficacy of the DISKUS formulations of salmeterol (SAL) 50mcg BID and fluticasone propionate (FP) 500mcg BID individually and in combination as salmeterol 50mcg/fluticasone propionate 500mcg BID (SFC 50/500) compared to placebo in COPD subjects. http://www.gsk-clinicalstudyregister.com/ (accessed 3 March 2014).
  • Hanania NA. Inhaled salmeterol/fluticasone propionate combination in chronic obstructive pulmonary disease. American Journal of Respiratory Medicine 2002;1(4):284.
  • Hanania NA, Darken P, Horstman D, Reisner C, Lee B, Davis S, et al. The efficacy and safety of fluticasone propionate (250 microg)/salmeterol (50 microg) combined in the Diskus inhaler for the treatment of COPD. Chest 2003;124(3):834-43.
  • Hanania NA, Knobil K, Watkins M, Wire P, Yates J, Darken P, et al. Salmeterol and fluticasone propionate therapy administered by a single diskus in patients with COPD. [Abstract]. 68th Annual Chest Meeting; Nov 2–7; San Diego. 2002:S129.
  • Hanania NA, Ramsdell J, Payne K, Davis S, Horstman D, Lee B, et al. Improvements in airflow and dyspnea in COPD patients following 24 weeks treatment with salmeterol 50mcg and fluticasone propionate 250mcg alone or in combination via the diskus. American Journal of Respiratory and Critical Care Medicine 2001;163(5 Suppl):A279.
  • Horstman D, Darken P, Davis S, Lee B. Improvements in FEV1 and symptoms in poorly reversible COPD patients following treatment with salmeterol 50mcg/fluticasone propionate 250mcg combination[Abstract]. European Respiratory Journal 2003;22(Suppl 45):Abstract No: [P434].
  • Knobil K, Yates J, Horstman D, Darken P, Wire P. Combination of fluticasone and salmeterol (Advair Diskus®) improves cough in patients with chronic obstructive pulmonary disease. [Abstract]. 68th Annual Chest Meeting; Nov 2-7; San Diego. 2002:P288.
  • Mahler DA, Darken P, Brown CP, Knobil K. Predicting lung function responses to combination therapy in chronic obstructive pulmonary disease (COPD) [Abstract]. National COPD conference; Nov 14-15; Arlington. 2003:Abstract no: 1081.
  • Mahler DA, Darken P, Brown CP, Knobil K. Predicting lung function responses to salmeterol/fluticasone propionate combination therapy in COPD [Abstract]. European Respiratory Journal 2003;22(Suppl 45):Abstract No: [P429].
  • Mahler DA, Wire P, Horstman D, Chang CN, Yates J, Fischer T, et al. Effectiveness of fluticasone propionate and salmeterol combination delivered via the diskus device in the treatment of chronic obstructive pulmonary disease. American Journal of Respiratory and Critical Care Medicine 2002;166(8):1084-91.
  • Spencer M, Wire P, Lee B, Chang C, Darken P, Hortsman D, et al. Patients with COPD using salmeterol/fluticasone propionate combination therapy experience improved quality of life [Abstract]. European Respiratory Journal 2003;22 Suppl 45:Abstract No: [P438].
  • Spencer MD, Anderson JA. Salmeterol/fluticasone combination produces clinically important benefits in dyspnea and fatigue [Abstract]. American Thoracic Society International Conference; May 20-25; San Diego. 2005:[B93] [Poster: 308].
Kardos 2007 {published data only}
  • GlaxoSmithKline. A multicentre, randomised, double-blind, parallel group, placebo-controlled study to compare the efficacy and safety of inhaled salmeterol/fluticasone propionate combination product 25/250 µg two puffs bd and fluticasone propionate 250µg two puffs bd alone, all administered via metered dose inhalers (MDI), in the treatment of subjects with chronic obstructive pulmonary disease (COPD) for 52 weeks. http://www.gsk-clinicalstudyregister.com/ (accessed 3 March 2014).
  • Kardos P, Wencker M. Combination therapy with salmeterol and fluticasone propionate (SFC) is more effective than salmeterol (SAL) alone in reducing exacerbations of COPD [Abstract]. European Respiratory Journal 2005;26(Suppl 49):Abstract No. 1944.
  • Kardos P, Wencker M, Glaab T, Vogelmeier C. Impact of salmeterol/fluticasone propionate versus salmeterol on exacerbations in severe chronic obstructive pulmonary disease. American Journal of Respiratory and Critical Care Medicine 2007;175(2):144-9.
  • Vogelmeier C, Wencker M, Glaab T, Kardos P. Combination therapy with salmeterol and fluticasone propionate (SFC) improves quality of life (QOL) more than salmeterol (SAL) alone in COPD [Abstract]. Norwegian Thoracic Society 42nd Nordic Lung Conference; June 9-11; Trondheim. 2005; Vol. 15, issue Suppl 22.
  • Vogelmeier CF, Wencker M, Glaab TH, Kardos P. Number needed to treat (NNT) to reduce exacerbations in severe COPD comparing salmeterol/fluticasone propionate (SFC) with salmeterol (SAL) treatment [Abstract]. American Thoracic Society International Conference; May 19-21; San Diego. 2006:A110 [Poster J8].
Kornmann 2011 {published data only}
  • Kornmann O, Dahl R, Centanni S, Dogra A, Owen R, Lassen C, et al. Once-daily indacaterol versus twice-daily salmeterol for COPD: a placebo-controlled comparison. European Respiratory Journal 2011;37(2):273-9.
  • Kornmann O, Luthra A, Owen R, Lassen C, Kramer B. Once-daily indacaterol provides superior bronchodilation, health status and clinical outcomes compared with salmeterol in patients with chronic obstructive COPD: a 26-week placebo-controlled study [Abstract]. Chest 2009;136(4):152S.
Lapperre 2009 {published data only}
  • Gosman MME, Lapperre TS, Snoeck-Stroband JB, Jansen DF, Kerstjens HAM, Hiemstra PS, et al. Effect of 6 months therapy with inhaled fluticasone propionate (FP) with or without salmeterol (S) on bronchial inflammation in COPD [Abstract]. American Thoracic Society International Conference; May 19-21; San Diego. 2006:A111 [Poster J15].
  • Kunz LIZ, Strebus J, Budulac SE, Lapperre TS, Sterk PJ, Postma DS, et al. Inhaled steroids modulate extracellular matrix composition in bronchial biopsies of COPD patients: a randomized, controlled trial. PLoS One 2013;8(5):e63430.
  • Lapperre TS, Snoeck-Stroband JB, Gosman MM, Jansen DF, van Schadewijk A, Thiadens HA, et al. Effect of fluticasone with and without salmeterol on pulmonary outcomes in chronic obstructive pulmonary disease: a randomized trial. Annals of Internal Medicine 2009;151(8):517-27.
  • Lapperre TS, Snoeck-Stroband JB, Gosman MM, Sont JK, Jansen DF, Rabe KF, et al. Effects of 30 vs 6 months treatment with inhaled fluticasone (FP) with or without salmeterol (S) on bronchial inflammation in COPD [Abstract]. American Thoracic Society International Conference; May 18-23; San Francisco. 2007:Poster #A39.
  • Snoeck-Stroband JB, Kerstjens HAM, Lapperre TS, Boezen HM, Thiadens HA, ten Hacken NHT, et al. Smoking, sputum cell counts, diffusion capacity and hyperinflation predict beneficial effects of long-term inhaled corticosteroids (ICS) on FEV1-decline in patients with mild-to-moderate COPD [Abstract]. European Respiratory Society 20th Annual Congress; Sep 18-22; Barcelona. 2010:[P4015].
  • Snoeck-Stroband JB, Lapperre TS, Boezen HM, Sont JK, Thiadens HA, Timens W, et al. Predicting the benefits by inhaled steroids on the accelerated decline of FEV1 in COD [Abstract]. American Thoracic Society International Conference; May 16-21; Toronto. 2008:A519[#705].
  • Snoeck-Stroband JB, Lapperre TS, Gosman MME, Assendelft WJJ, Boezen HM, ten Hacken NHT, et al. Patient-reported clinical control and peak-flow:effects of 30 versus 6 month treatment with inhaled corticosteroids (ICS) with/without long-acting B2-agonists (LABA) in moderately severe COPD [Abstract]. American Thoracic Society International Conference; May 15-20 San Diego. 2009:A2923 [Poster #G37].
  • Snoek-Stroband JB, Lapperre TS, Gosman MM, Sont JK, Jansen DF, Stolk J, et al. Effects of 30 vs 6 months treatment with inhaled fluticasone propionate (FP) with or without salmeterol (S) on FEV1 PC20 and health status in COPD [Abstract]. American Thoracic Society International Conference; May 18-23; San Francisco. 2007:Poster #A38.
Laptseva 2002 {published data only}
  • Laptseva IM, Laptseva EA, Borshchevsky VV, Gurevich G, Kalechits O. Inhaled budesonide in the management of chronic obstructive pulmonary diseases [abstract]. European Respiratory Society 12th Annual Congress; Sep 14-18; Stockholm. 2002:abstract nr: P1584.
Mahler 2002 {published data only}
  • Ferguson G, Funck-Brentano C, Fischer T, Darken P, Troy S, Compton C, et al. Cardiovascular safety of salmeterol in patients with COPD. American Journal of Respiratory and Critical Care Medicine 2002;165(Suppl 8):A228.
  • Ferguson GT, Funck-Brentano C, Fischer T, Darken P, Reisner C. Cardiovascular safety of salmeterol in COPD. Chest 2003;123(6):1817-24.
  • GlaxoSmithKline. A randomized, double-blind, placebo-controlled, parallel-group trial evaluating the safety and efficacy of the DISKUS formulations of salmeterol (SAL) 50mcg BID and fluticasone propionate (FP) 250mcg BID individually and in combination as salmeterol 50mcg/fluticasone propionate 250mcg BID (SFC 50/250) compared to placebo in COPD subjects. http://www.gsk-clinicalstudyregister.com/ (accessed 3 March 2014).
  • Littner M, Yates J, Fischer T, Horstman D, Wire P. Improvements in FEV1 and symptoms in poorly-reversible COPD patients following 24 weeks of treatment with the salmeterol/fluticasone propionate combination 50/500 BID via the Diskus™ inhaler. European Respiratory Journal 2001;18(Suppl 33):176s.
  • Mahler DA, Wire P, Horstman D, Chang CN, Yates J, Fischer T, et al. Effectiveness of fluticasone propionate and salmeterol combination delivered via the Diskus device in the treatment of chronic obstructive pulmonary disease. American Journal of Respiratory and Critical Care Medicine 2002;166(8):1084-91.
  • Mahler DA, Wong E, Giessel G, Clifford D, Chang C, Yates J, et al. Improvements in FEV1 and symptoms in COPD patients following 24 weeks of twice daily treatment with salmeterol 50/ fluticasone propionate 500 combination. American Journal of Respiratory and Critical Care Medicine 2001;163(5 Suppl):A279.
  • Spencer M, Wire P, Lee B, Chang C, Darken P, Hortsman D. Patients with COPD using salmeterol/fluticasone propionate combination therapy experience improved quality of life [Abstract]. European Respiratory Journal 2003;22(Suppl 45):Abstract P438.
  • Spencer MD, Anderson JA. Salmeterol/fluticasone combination produces clinically important benefits in dyspnea and fatigue [Abstract]. American Thoracic Society International Conference; May 20-25; San Diego. 2005.
  • Spencer MD, Karia N, Anderson J. The clinical significance of treatment benefits with the salmeterol/fluticasone propionate 50/500mcg combination in COPD [Abstract]. European Respiratory Journal 2004;24(Suppl 48):290s.
Mahmud 2007 {published data only}
  • Mahmud AM, Gupta DK, Khan AS, Hassan R, Hossain A, Rahman M, et al. Comparison of once daily tiotropium with twice daily salmeterol in Bangladeshi patients with moderate COPD [Abstract]. Respirology (Carlton, Vic.) 2007;12(Suppl 4):A211.
Niewoehner 2005 {published data only}
  • Anonymous. Tiotropium reduces exacerbations in COPD. Pharmaceutical Journal 2004;272(7302):696.
  • Kesten S, Plautz M, Piquette CA, Habib MP, Niewoehner DE. Premature discontinuation of patients: a potential bias in COPD clinical trials. European Respiratory Journal 2007;30(5):898-906.
  • Niewoehner D, Gonzalez-Rothi R, Shigeoka J, Korducki L, Cassino C, Kesten S, et al. Reduced COPD exacerbations in patients without first-dose peak FEV increases 15% with tiotropium [Abstract]. American Thoracic Society International Conference; May 20-25; San Diego. 2005:[B93] [Poster: 319].
  • Niewoehner D, Rice K, Cote C, Korducki L, Cassino C, Kesten S. Characteristics of COPD and response to once-daily tiotropium in African Americans in the VA medical system [Abstract]. American Thoracic Society International Conference; May 20-25; San Diego. 2005:[A43] [Poster: F41].
  • Niewoehner D, Rice K, Cote C, Paulson D, Cooper JA, Korducki L, et al. Reduced COPD exacerbations and associated health care utilization with once-daily tiotropium (TIO) in the VA medical system [Abstract]. American Thoracic Society 100th International Conference, May 21-26, Orlando. 2004:A84.
  • Niewoehner DE, Lokhnygina Y, Rice K, Kuschner WG, Sharafkhaneh A, Sarosi GA, et al. Risk indexes for exacerbations and hospitalizations due to COPD. Chest 2007;131(1):20-8.
  • Niewoehner DE, Rice K, Cassino C, Leimer I, Kesten S. Reductions in COPD exacerbations with tiotropium in African Americans in the VA medical system [Abstract]. American Thoracic Society International Conference; May 18-23; San Francisco. 2007:Poster #A51.
  • Niewoehner DE, Rice K, Cote C, Paulson D, Cooper JAD Jr, Korducki L, et al. Prevention of exacerbations of chronic obstructive pulmonary disease with tiotropium, a once-daily inhaled anticholinergic bronchodilator: a randomized trial. Annals of Internal Medicine 2005;143(5):317-26.
  • Rice KL, Leimer I, Kesten S, Niewoehner DE. Responses to tiotropium in African-American and Caucasian patients with chronic obstructive pulmonary disease. Translational Research 2008;152(2):88-94.
Ohar 2013 {published data only}
  • Ohar JA, Crater G, Emmett A, Ferro T, Morris A, Raphiou I, et al. Effects of fluticasone propionate/salmeterol combination 250/50mcg bid (advair diskus) vs. salmeterol 50mcg bid (serevent diskus) on chronic obstructive pulmonary disease (COPD) exacerbation rate, following acute exacerbation or hospitalization. American Journal of Respiratory and Critical Care Medicine 2013;187(Meeting Abstracts):A2439.
Ozol 2005 {published data only}
  • Ozol D, Aysan T, Aytemur Z, Veral A, Sebik F. The effect of inhaled corticosteroids on bronchoalveolar lavage interleukin-8 levels and cell percentage in stable chronic obstructive pulmonary disease patients. European Respiratory Journal 2001;18(Suppl 33):212s.
  • Ozol D, Aysan T, Solak ZA, Mogulkoc N, Veral A, Sebik F. The effect of inhaled corticosteroids on bronchoalveolar lavage cells and IL-8 levels in stable COPD patients. Respiratory Medicine 2005;99(12):1494-500.
Paggiaro 1998 {published data only}
  • GlaxoSmithKline. A multi-centre, randomised, double-blind, parallel group study of the efficacy and safety of inhaled fluticasone propionate 1000 mcg daily with placebo in chronic obstructive pulmonary disease. http://www.gsk-clinicalstudyregister.com/ (accessed 3 March 2014). [GSK: FLIT97]
  • GlaxoSmithKline. A multicentre, double-blind, placebo-controlled, parallel group study of the efficacy and tolerability of long-term inhaled fluticasone propionate 500 mcg twice daily via a Volumatic Spacer device in patients with non-asthmatic chronic obstructive pulmonary disease, including an acute oral corticosteroid trial. http://www.gsk-clinicalstudyregister.com/ (accessed 6 March 2014). [GSK: FLTB3054]
  • Paggiaro PL, Dahle R, Bakran I, Frith L, Hollingworth K, Efthimiou J. Multicentre randomised placebo-controlled trial of inhaled fluticasone propionate in patients with chronic obstructive pulmonary disease. International COPD Study Group. Lancet 1998;351(9105):773-80.
  • Paggiaro PL, Dahle R, Bakran I, Hollingworth K, Efthimiou J. A multicentre double-blind, placebo-controlled study investigating the effect of inhaled fluticasone propionate in patients with chronic obstructive pulmonary disease. European Respiratory Journal 1997;10 Suppl 25:427S.
  • Paggiaro PL, Dahle R, Bakran I, Hollingworth K, Efthimiou J. A multicentre, randomised, double-blind, placebo-controlled trial of inhaled fluticasone propionate (FP) in patients with chronic obstructive pulmonary disease. American Journal of Respiratory and Critical Care Medicine 1998;157(3 Suppl):A799.
Pauwels 1999 {published data only}
  • Johnell O, Pauwels R, Löfdahl CG, Laitinen LA, Postma DS, Pride NB, et al. Bone mineral density in patients with chronic obstructive pulmonary disease treated with budesonide Turbuhaler(R). European Respiratory Journal 2002;19(6):1058-63.
  • Liesker JJ, van der Velde V, Meysman M, Vinckek W, Wollmer P, Hansson L, et al. The effects of formoterol on exercise capacity in COPD. European Respiratory Society 9th Annual Congress; Oct 9-13; Madrid. 1999:[P2511].
  • Löfdahl CG, Postma DS, Laitinen LA, Ohlsson SV, Pauwels RA, Pride NB. The European Respiratory Society study on chronic obstructive pulmonary disease (EUROSCOP): recruitment methods and strategies. Respiratory Medicine 1998;92(3):467-72.
  • Noppen M, Vincken W. Effects of high-dose inhaled fluticasone propionate (FP) on cellular and solute composition in bronchial (Brl) and bronchoalveolar (BAL) lavage fluid in COPD: a placebo controlled, double-blind study. American Journal of Respiratory and Critical Care Medicine 1998;157(3 Suppl):A803.
  • Pauwels RA, Löfdahl CG, Laitinen LA, Schouten JP, Postma DS, Pride NB, et al. Long-term treatment with inhaled budesonide in persons with mild chronic obstructive pulmonary disease who continue smoking. European Respiratory Society Study on Chronic Obstructive Pulmonary Disease.[see comment]. New England Journal of Medicine 1999;340(25):1948-53.
  • Pauwels RA, Löfdahl CG, Pride NB, Postma DS, Laitinen LA, Ohlsson SV. European Respiratory Society study on chronic obstructive pulmonary disease (EUROSCOP): hypothesis and design. European Respiratory Journal 1992;5(10):1254-61.
Powrie 2007 {published data only}
  • Powrie D, Wilkinson T, Donaldson G, Viel K, Jones P, Scrine K, et al. The effect of tiotropium on diary based exacerbation frequency in COPD [Abstract]. American Thoracic Society International Conference; May 19-21; San Diego. 2006:A604 [Poster H11].
  • Powrie DJ, Donaldson GC, Wilkinson TM, Jones P, Viel K, Kesten S, et al. Tiotropium reduces exacerbations and common colds in patients with COPD [Abstract]. American Thoracic Society International Conference; May 18-23; San Francisco. 2007:Poster #A50.
  • Powrie DJ, Wilkinson TMA, Donaldson GC, Jones P, Scrine K, Viel K, et al. Effect of tiotropium on sputum and serum inflammatory markers and exacerbations in COPD. European Respiratory Journal 2007;30(3):472-8.
  • Powrie j, Wilkinson M, Donaldson C, Wedzicha A. Tiotropium reduces subjectively reported sputum production in COPD. European Respiratory Journal 2006;28(Suppl 50):661s [P3839].
Renkema 1996 {published data only}
  • Renkema TE, Kerstjens HA, Schouten JP, Vonk JM, Koëter GH, Postma DS. The importance of serum IgE for level and longitudinal change in airways hyperresponsiveness in COPD. Clinical and Experimental Allergy 1998;28(10):1210-8.
  • Renkema TE, Schouten JP, Koëter GH, Postma DS. Effects of long-term treatment with corticosteroids in COPD. Chest 1996;109(5):1156-62.
Rennard 2009 {published data only}
  • Bleecker ER, Meyers DA, Bailey WC, Sims AM, Bujac SR, Goldman M, et al. ADRB2 polymorphisms and budesonide/formoterol responses in COPD. Chest 2012;142(2):320-8.
  • Celli BR, Tashkin DP, Rennard SI, McElhattan J, Martin UJ. Bronchodilator responsiveness and onset of effect with budesonide/formoterol pMDI in COPD. Respiratory Medicine 2011;105(8):1176-88.
  • Laties A, Rennard SI, Tashkin DP, Suchower LJ, Martin UJ. Effect of budesonide/formoterol pressurized metered-dose inhaler (bud/fm pmdi) on ophthalmologic assessments in moderate to very severe chronic obstructive pulmonary disease (COPD) patients: results from a 1-year, randomized, controlled clinical trial [Abstract]. Chest 2010;138(4):468A.
  • Nelson HS, Tashkin DP, Rennard SI, Martin P, Goldman M, Silkoff PE. Onset of bronchodilation with budesonide and formoterol administered in one pressurized metered-dose inhaler in patients with moderate to very severe chronic obstructive pulmonary disease [Abstract]. Chest 2008;134(4):105002s.
  • Rennard SI, Tashkin DP, Martin P, Goldman M, Martin UJ. Effect of budesonide/formoterol pressurized metered-dose inhaler (pMDI) on exacerbations in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) [Abstract]. American Thoracic Society International Conference; May 15-20 San Diego. 2009:A1513 [Poster #K65].
  • Rennard SI, Tashkin DP, McElhattan J, Goldman M, Ramachandran S, Martin UJ, et al. Efficacy and tolerability of budesonide/formoterol in one hydrofluoroalkane pressurized metered-dose inhaler in patients with chronic obstructive pulmonary disease: results from a 1-year randomized controlled clinical trial. Drugs 2009;69(5):549-65.
  • Rennard SI, Tashkin DP, McElhattan J, Goldman M, Silkoff PE. Long-term efficacy of budesonide/formoterol administered via one pressurized metered-dose inhaler in patients with moderate to very severe chronic obstructive pulmonary disease [Abstract]. Chest 2008;134(4):103001s.
  • Rennard SI, Tashkin DP, McElhattan J, Goldman M, Silkoff PE. Long-term tolerability of budesonide and formoterol administered in one pressurized metered-dose inhaler in patients with moderate to very severe chronic obstructive pulmonary disease [Abstract]. Chest 2008;134(4):103003s.
  • Rennard SI, Tashkin DP, Suchower LJ, Martin UJ. Effect of budesonide/formoterol pressurized metered-dose inhaler (BUD/FM pMDI) on bone mineral density (BMD) in moderate to very severe chronic obstructive pulmonary disease (COPD) patients: results from a 1-year, randomized, controlled clinical trial [Abstract]. Chest 2010;138(4):863A.
Rossi 2002 {published data only}
  • Amgott TR, Kristufek P, Levine B, Byrne A, Till D. Effect of inhaled formoterol and oral slow-release theophylline on peak expiratory flow and symptoms in patients with COPD. American Journal of Respiratory and Critical Care Medicine 2000;161(3 Suppl):A582.
  • Kristufek P, Amgott TR, Levine B, Byrne A, Colacchio C. Comparison of the efficacy and safety of inhaled formoterol dry powder and oral slow-release theophylline in patients with COPD. American Journal of Respiratory and Critical Care Medicine 2000;161(Suppl 3):A489.
  • Kristufek P, Levine B, Della Cioppa G, Byrne A, Till D. Bronchodilatory effects of formoterol in patients with chronic obstructive pulmonary disease (COPD) are not influenced by concomitant corticosteroid use. European Respiratory Journal 2001;18(Suppl 33):514s.
  • Kristufek P, Levine B, Till D, Byrne A. Inhaled formoterol (foradil(r)) improves lung function in patients with both reversible and poorly reversible COPD [abstract]. American Journal of Respiratory and Critical Care Medicine 2001;163(5 Suppl):A280.
  • Rossi A, Kristufek P, Levine BE, Thomson MH, Till D, Kottakis J, et al. Comparison of the efficacy, tolerability, and safety of formoterol dry powder and oral, slow-release theophylline in the treatment of COPD. Chest 2002;121(4):1058-69.
Schermer 2009 {published data only}
  • Chavannes N, Schermer T, Woulters EFM, Folgering H, Akkermans R, Metsemakers J, et al. Demographic and clinical determinants of response to N-acetylcysteine versus fluticasone in mild to moderate COPD in primary care: the COOPT study [Abstract]. European Respiratory Journal 2005;26(Suppl 49):Abstract No. 1356.
  • Chavannes NH, Schermer TR, Wouters EF, Akkermans RP, Dekhuijzen RP, Muris JW, et al. Predictive value and utility of oral steroid testing for treatment of COPD in primary care: the COOPT study. International Journal of Chronic Obstructive Pulmonary Disease 2009;4:431-6.
  • Chavannes NH, Schermer TRJ, Wouters EFM, van Weel C, van Schayck CP. Treatment of COPD in general practice: the COOPT study. European Respiratory Journal 2001;18(Suppl 33):348s.
  • Schermer T, Chavannes N, Dekhuijzen R, Wouters E, Muris J, Akkermans R, et al. Fluticasone and N-acetylcysteine in primary care patients with COPD or chronic bronchitis. Respiratory Medicine 2009;103(4):542-51.
  • Van Weel C, Schermer T. Quality of life is not an indicator of COPD severity. Huisarts en Wetenschap 2011;54(6):294-7.
SCO100470 {published data only}
  • GlaxoSmithKline. A multicentre, randomised, double-blind, parallel group, 24-week study to compare the effect of the salmeterol/fluticasone propionate combination product 50/250 mcg, with salmeterol 50 mcg both delivered twice daily via the DISKUS/ACCUHALER inhaler on lung function and dyspnoea in subjects with chronic obstructive pulmonary disease (COPD). http://www.gsk-clinicalstudyregister.com/ (accessed 6 March 2014).
SCO30002 {published data only}
  • GlaxoSmithKline. A multicentre, randomised, double-blind, parallel group, placebo-controlled study to compare the efficacy and safety of inhaled salmeterol/fluticasone propionate combination product 25/250 µg two puffs Bd and fluticasone propionate 250 µg two puffs Bd alone, all administered via metered dose inhalers (MDI), in the treatment of subjects with chronic obstructive pulmonary disease (COPD) for 52 weeks. http://www.gsk-clinicalstudyregister.com/ (accessed 6 March 2014).
SCO40041 {published data only}
  • ZuWallack R, Fogarty C, Giessel G, McClung, Locantore N, Raphiou I, et al. Effect of fluticasone propionate/salmeterol combination on change in bone mineral density in subjects with COPD [Abstract]. Chest 2008;134(4):104002s.
Senderovitz 1999 {published data only}
  • Senderovitz T, Maltbaek N, Pedersen B, Norgaard M, Nielsen C, Vestbo J, et al. Prednisolone followed by inhaled budesonide vs placebo in chronic obstructive pulmonary disease. European Respiratory Journal 1997;10(Suppl 25):257S.
  • Senderovitz T, Vestbo J, Frandsen J, Maltbaek N, Norgaard M, Nielsen C, et al. Steroid reversibility test followed by inhaled budesonide or placebo in outpatients with stable chronic obstructive pulmonary disease. The Danish Society of Respiratory Medicine. Respiratory Medicine 1999;93(10):715-8.
Shaker 2009 {published data only}
  • Shaker SB, Dirksen A, Ulrik CS, Hestad M, Stavngaard T, Laursen LC, et al. The effect of inhaled corticosteroids on the development of emphysema in smokers assessed by annual computed tomography. COPD 2009;6(2):104-11.
  • Shaker SB, Stavngaard T, Laursen LC, Stoel BC, Dirksen A. Rapid fall in lung density following smoking cessation in COPD. COPD 2011;8(1):2-7.
  • Shaker SB, Stavngaard T, Stoel B, Dirksen A. The effect of inhaled corticosteroids on CT-lung density in current smokers with COPD [Abstract]. American Thoracic Society International Conference; May 20-25; San Diego. 2005:[A92] [Poster: 814].
Sharafkhaneh 2012 {published data only}
  • Sharafkhaneh A, Southard J, Goldman M, Uryniak T, Martin UJ. Long-term effect of budesonide/formoterol pressurized metered-dose inhaler on exacerbations and pulmonary function in patients with chronic obstructive pulmonary disease [Abstract]. American Journal of Respiratory and Critical Care Medicine 2011;183(Meeting Abstracts):A1599.
  • Sharafkhaneh A, Southard JG, Goldman M, Uryniak T, Martin UJ. Effect of budesonide/formoterol pMDI on COPD exacerbations: a double-blind, randomized study. Respiratory Medicine 2012;106(2):257-68.
  • Sharafkhaneh A, Uryniak T, Martin U. Long-term effects of budesonide/formoterol pressurized metered-dose inhaler on chronic obstructive pulmonary disease (COPD) symptoms and health status in patients with COPD [Abstract]. Chest 2011;140(4):528A.
  • Southard JG, Sharafkhaneh A, Goldman M, Uryniak T, Martin UJ. Long-term tolerability of budesonide/formoterol pressurized metered-dose inhaler in patients with chronic obstructive pulmonary disease and a history of exacerbations [Abstract]. American Journal of Respiratory and Critical Care Medicine 2011;183(Meeting Abstracts):A1597.
SLMF4010 {published data only}
  • GlaxoSmithKline. Multicentre, randomised, parallel group, placebo-controlled, double-blind study, stratified on tobacco status at enrolment, evaluating during 6 months the efficacy of salmeterol powder for inhalation, 50 µg two times per day for the reduction of thoracic distension in subjects with chronic obstructive pulmonary disease (COPD). http://www.gsk-clinicalstudyregister.com/ (accessed 6 March 2014).
SPARK 2013 {published data only}
  • Decramer M, Wedzicha JA, Ficker J, Fowler Taylor A, D'Andrea P, Arrasate C, et al. Once-daily QVA149 improves health-related quality of life in patients with severe to very severe COPD: the SPARK study. American Journal of Respiratory and Critical Care Medicine 2013;187(Meeting Abstracts):A4257.
  • Decramer M, Wedzicha JA, Sandstrom T, Niewoehner D, Fowler Taylor A, D'Andrea P, et al. Safety and tolerability of QVA149, glycopyrronium and tiotropium in patients with severe to very severe COPD: the SPARK study. American Journal of Respiratory and Critical Care Medicine 2013;187(Meeting Abstracts):A1479.
  • Wedzicha JA, Decramer M, Ficker J, Fowler Taylor A, D'Andrea P, Arrasate C, et al. Dual bronchodilation with QVA149 reduces COPD exacerbations: the SPARK study. American Journal of Respiratory and Critical Care Medicine 2013;187(Meeting Abstracts):A2428.
  • Wedzicha JA, Decramer M, Ficker J, Niewoehner DE, Sandstrom T, Fowler Taylor A. Efficacy and safety of QVA149 versus glycopyrronium and tiotropium in severe to very severe COPD: the SPARK study. American Journal of Respiratory and Critical Care Medicine 2013;187(Meeting Abstracts):A2429.
  • Wedzicha JA, Decramer M, Ficker JH, Niewoehner DE, Sandstrom T, Taylor AF, et al. Analysis of chronic obstructive pulmonary disease exacerbations with the dual bronchodilator QVA149 compared with glycopyrronium and tiotropium (SPARK): a randomised, double-blind, parallel-group study. The Lancet Respiratory Medicine 2013;1(3):199-209.
Szafranski 2003 {published data only}
  • Anderson P. Budesonide/formoterol in a single inhaler (Symbicort) provides early and sustained improvement in lung function in moderate to severe COPD [Abstract]. Thorax 2002;57(Suppl III):iii43.
  • AstraZeneca. A placebo-controlled 12 month efficacy study of the fixed combination budesonide/formoterol compared with budesonide and formoterol as monotherapies in patients with chronic obstructive pulmonary disease (COPD). http://www.astrazenecaclinicaltrials.com/ (accessed 6 March 2014). [AstraZeneca: SD-039-0629]
  • Borgstrom L, Asking L, Olsson H, Peterson S. Lack of interaction between disease severity and therapeutic response with budesonide/formoterol in a single inhaler [Abstract]. American Thoracic Society 100th international conference; May 21-26; Orlando. 2004:C22 [Poster 505]. [CRS-ID: 4900126000002246]
  • Calverley P, Pauwels Dagger R, Lofdahl CG, Svensson K, Hi JT, Carlsson LG, et al. Relationship between respiratory symptoms and medical treatment in exacerbations of COPD. European Respiratory Journal 2005;26(3):406-13.
  • Calverley PM, Szafranski W, Calverley PMA, Andersson A. Budesonide/formoterol is a well-tolerated long term maintenance therapy for COPD [Abstract]. European Respiratory Journal 2005;26(Suppl 49):Abstract No. 1917. [CRS-ID: 4900100000023248]
  • Calverley PMA (on behalf of the Symbicort® study group). Effect of budesonide/formoterol on severe exacerbations and lung function in moderate to severe COPD. Thorax 2002;57(Suppl III):iii44. [CRS-ID: 4900100000013852]
  • Calverley PMA, Thompson NC, Olsson H. Budesonide/formoterol in a single inhaler sustains lung function improvements in COPD [Abstract]. European Respiratory Journal 2003;22(Suppl 45):P435. [CRS-ID: 4900100000016773]
  • Campbell LMSW, Campell LW, Szafranski W, Campbell L, Campbell LM. Budesonide/formoterol in a single inhaler (symbicort(r)) reduces severe exacerbations in patients with moderate to severe COPD [Abstract]. Thorax 2002;57(Suppl III):iii43.
  • Dahl R, Cukier A, Olsson H. Budesonide/formoterol in a single inhaler reduces severe and mild exacerbations in patients with moderate to severe COPD [abstract]. European Respiratory Society 12th Annual Congress; Sep 14-18; Stockholm. 2002:abstract nr: P1575.
  • Egede FMG, Egede F, Menga G. Budesonide/formoterol in a single inhaler provides sustained relief from symptoms and night-time awakenings in moderate to severe COPD: results from a 1-year study [abstract]. European Respiratory Society 12th Annual Congress; Sep 14-18; Stockholm. 2002:abstract nr: P1574.
  • Halpin D, Stahl E, Lundback B, Anderson F, Peterson S. Treatment costs and number needed to treat (NNT) with budesonide/formoterol to avoid one exacerbation of COPD [Abstract]. American Thoracic Society 100th international conference; May 21-26; Orlando. 2004:D22 [Poster 525]. [CRS-ID: 4900100000017391]
  • Jones PW, Stahl E, Svensson K. Improvement in health status in patients with moderate to severe COPD after treatment with budesonide/formoterol in a single inhaler [abstract]. European Respiratory Society 12th Annual Congress; Sep 14-18; Stockholm. 2002:abstract nr: P1613.
  • Korsgaard JSR, Korsgaard J, Sansores R. Budesonide/formoterol (single inhaler) provides sustained relief from shortness of breath and chest tightness in a 1-year study of patients with moderate to severe COPD [abstract]. European Respiratory Society 12th Annual Congress; Sep 14-18; Stockholm. 2002:abstract nr: P1577.
  • Lange PSC, Lange P, Saenz C. Budesonide/formoterol in a single inhaler is well tolerated in patients with moderate to severe COPD: results of a 1-year study [abstract]. European Respiratory Society 12th Annual Congress; Sep 14-18; Stockholm. 2002:abstract nr: P1573.
  • Lofdahl C G, Lofdahl CG. Reducing the impact of COPD exacerbations: clinical efficacy of budesonide/formoterol. European Respiratory Review 2004;13(88):14-21. [CRS-ID: 4900100000060705]
  • Milanowski JNS, Milanowski J, Nahabedian S. Budesonide/formoterol in a single inhaler acts rapidly to improve lung function and relieve symptoms in patients with moderate to severe COPD [abstract]. European Respiratory Society 12th Annual Congress; Sep 14-18; Stockholm. 2002:abstract nr: P1576.
  • Szafranski W, Cukier A, Ramirez A, Menga G, Sansores R, Nahabedian S, et al. Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease. European Respiratory Journal 2003;21(1):74-81.
  • Szafranski W, Ramirez A, Peterson S. Budesonide/formoterol in a single inhaler provides sustained improvements in lung function in patients with moderate to severe COPD [abstract]. European Respiratory Society 12th Annual Congress; Sep 14-18; Stockholm. 2002:abstract nr: P2453.
Tashkin 2008 [SHINE] {published data only}
  • AstraZeneca. A 6-month double-blind, double-dummy, randomized, parallel group, multicenter efficacy & safety study of SYMBICORT® pMDI 2 x 160/4.5 mcg & 80/4.5 mcg bid compared to formoterol TBH, budesonide pMDI (& the combination) & placebo in COPD patients. http://www.astrazenecaclinicaltrials.com/ (accessed 6 March 2014).
  • Bleecker ER, Meyers DA, Bailey WC, Sims AM, Bujac SR, Goldman M, et al. ADRB2 polymorphisms and budesonide/formoterol responses in COPD. Chest 2012;142(2):320-8. [CRS-ID: 4900100000063501]
  • Bleecker ER, Meyers DA, Bailey WC, Sims AM, Bujac SR, Goldman M, et al. Effect of beta2-adrenergic receptor gene polymorphism gly16arg on response to budesonide/formoterol pressurized metered-dose inhaler in chronic obstructive pulmonary disease [Abstract]. American Journal of Respiratory and Critical Care Medicine 2011;183(Meeting Abstracts):A4086. [CRS-ID: 4900100000043833]
  • Celli BR, Tashkin DP, Rennard SI, McElhattan J, Martin UJ. Bronchodilator responsiveness and onset of effect with budesonide/formoterol pMDI in COPD. Respiratory Medicine 2011;105(8):1176-88. [CRS-ID: 4900100000026611]
  • Nelson HS, Tashkin DP, Rennard SI, Martin P, Goldman M, Silkoff PE. Onset of bronchodilation with budesonide and formoterol administered in one pressurized metered-dose inhaler in patients with moderate to very severe chronic obstructive pulmonary disease [Abstract]. Chest 2008;134(4):105002s. [CRS-ID: 4900100000024197]
  • Tashkin DP, Rennard SI, Martin P, Goldman M, Silkoff PE. Efficacy of budesonide/formoterol administered via one pressurized metered-dose inhaler over 6 months in patients with chronic obstructive pulmonary disease [Abstract]. Chest 2008;134(4):105001s.
  • Tashkin DP, Rennard SI, Martin P, Ramachandran S, Martin UJ, Silkoff PE, et al. Efficacy and safety of budesonide and formoterol in one pressurized metered-dose inhaler in patients with moderate to very severe chronic obstructive pulmonary disease: results of a 6-month randomized clinical trial. Drugs 2008;68:1975-2000.
Tashkin 2008a [UPLIFT] {published data only}
  • Antoniu SA. UPLIFT study: the effects of long-term therapy with inhaled tiotropium in chronic obstructive pulmonary disease. Expert Opinion on Pharmacotherapy 2009;10(4):719-22.
  • Boehringer Ingelheim. A randomized, double-blind, placebo-controlled, parallel group trial assessing the rate of decline of lung function with tiotropium 18 mcg inhalation capsule once daily in patients with chronic obstructive pulmonary disease (COPD). www.trials.boehringer-ingelheim.com (accessed 3 March 2014). [CRS-ID: 4900100000042876]
  • Braido F. UPLIFT study: the results and their implications. Multidisciplinary Respiratory Medicine 2009;4(Suppl 1):6s-12s.
  • Buhl R, Welte T, Vogelmeier C, Gillissen A, Voshaar T, Kogler H, et al. Early treatment of COPD with tiotropium. [German]. Pneumologie (Stuttgart, Germany) 2012;66(10):589-95.
  • Celli B, Decramer M, Kesten S, Liu D, Mehra S, Tashkin DP, et al. Mortality in the 4-year trial of tiotropium (UPLIFT) in patients with chronic obstructive pulmonary disease. American Journal of Respiratory and Critical Care Medicine 2009;180(10):948-55.
  • Celli B, Decramer M, Tashkin D, Cassino C, Burkhart D, Kesten S. Frequency of acute flow and volume responses to bronchodilator administration in patients with COPD [Abstract]. European Respiratory Journal 2007;30(Suppl 51):525s [3163].
  • Celli B, Decramer M, Tashkin DP, Bukhart D, Kesten S, Cassino C. Differences in baseline FEV1 and tobacco use in COPD patients from different racial subgroups [Abstract]. American Thoracic Society International Conference; May 18-23; San Francisco. 2007:Poster #923.
  • Celli B, Kesten S, Lystig T, Tashkin DP, Decramer M. Long-term changes in inspiratory capacity: an analysis from the UPLIFT(R) trial [Abstract]. American Journal of Respiratory and Critical Care Medicine 2010;181(Meeting Abstracts):A4482. [CRS-ID: 4900100000025219]
  • Celli B, Tashkin D, Decramer M, Burkhart D, Cassino C, Kesten S. Acute bronchodilator responsiveness in a global respiratory trial (UPLIFT) following maximal inhaled bronchodilators. European Respiratory Journal 2005;26(Suppl 49):716s. [CRS-ID: 4900100000035643]
  • Celli BR, Decramer M, Lystig T, Kesten S, Tashkin DP. Longitudinal inspiratory capacity changes in chronic obstructive pulmonary disease. Respiratory Research 2012;13:66.
  • Corhay JL, Louis R. The UPLIFT study (Understanding Potential Long-term Impacts on Function with Tiotropium). Revue Medicale de Liege 2009;64(1):52-7.
  • Decramer M, Celli B, Burkhart D, Kesten S, Mehra S, Liu D, et al. The effect of tiotropium on COPD GOLD stage II during the four-year UPLIFT trial [Abstract]. American Thoracic Society International Conference; May 16-21; Toronto. 2008:A2466.
  • Decramer M, Celli B, Kesten S, Liu D, Menjoge S, Senn S, et al. Statistical approaches to analysis of exacerbations in the UPLIFT(R) trial [Abstract]. American Journal of Respiratory and Critical Care Medicine 2010;181(Meeting Abstracts):A1527.
  • Decramer M, Celli B, Kesten S, Lystig T, Mehra S, Tashkin DP, et al. Effect of tiotropium on outcomes in patients with moderate chronic obstructive pulmonary disease (UPLIFT): a prespecified subgroup analysis of a randomised controlled trial. [see comment]. Lancet 2009;374(9696):1171-8.
  • Decramer M, Celli B, Tashkin DP, Burkhart D, Kesten S, Cassino C. Regional differences in the treatment of patients with moderate COPD enrolled in a global clinical trial. European Respiratory Journal 2006;28(Suppl 50):526s. [CRS-ID: 4900100000035644]
  • Decramer M, Celli B, Tashkin DP, Pauwels RA, Burkhart D, Cassino C, et al. Clinical trial design considerations in assessing long-term functional impacts of tiotropium in COPD: the UPLIFT trial. Journal of Chronic Obstructive Pulmonary Disease 2004;1(2):303-12.
  • Decramer M, Kesten S, Celli B, Tashkin DP. How much lift to the UPLIFT study? - Authors' reply. Lancet 2010;375(9710):198.
  • Decramer M, Molenberghs G, Liu D, Celli B, Kesten S, Lystig T, et al. Premature discontinuation during the UPLIFT study. Respiratory Medicine 2011;105(10):1523-30.
  • Decramer M, Pauwels R, Celli B, Tashkin D, Burkhart D, Cassino C, et al. Effectiveness of a spirometric quality assurance program in a large-scale global COPD trial (UPLIFT). European Respiratory Journal 2004;24(Suppl 48):32s. [CRS-ID: 4900100000035646]
  • Decramer M, Tashkin D, Celli B, Franceschina J, Fiori L. Use of regular feedback on spirometry testing in a long-term multinational COPD trial [Abstract]. American Thoracic Society International Conference; May 16-21; Toronto. 2008:Poster #D79. [CRS-ID: 4900100000023039]
  • Fernandez L, Kesten S, Liu D, Decramer M, Tashkin D, Celli B, et al. Efficacy of tiotropium in COPD patients from Asia: a subgroup analysis from the UPLIFT trial [Abstract]. Congress of the Asian Pacific Society of Respirology; Nov 22-25; Manila. 2010.
  • Fukuchi Y, Fernandez L, Kuo HP, Mahayiddin A, Celli B, Decramer M, et al. Efficacy of tiotropium in COPD patients from Asia: a subgroup analysis from the UPLIFT trial. Respirology (Carlton, Vic.) 2011;16(5):825-35.
  • Halpin D, Decramer M, Celli B, Martin A, Leimer I, Metzdorf N, et al. Effectiveness of tiotropium in low-risk patients according to new GOLD severity grading [Abstract]. European Respiratory Journal 2012;40(Suppl 56):392s [P2190].
  • Halpin DG, Decramer M, Celli B, Kesten S, Liu D, Tashkin DP. Exacerbation frequency and course of COPD. International Journal of Chronic Obstructive Pulmonary Disease 2012;7:653-61.
  • Halpin DM, Decramer M, Celli B, Kesten S, Leimer I, Tashkin DP. Risk of nonlower respiratory serious adverse events following COPD exacerbations in the 4-year UPLIFT trial. Lung 2011;189(4):261-8.
  • Hanania N, Kesten S, Celli B, Decramer M, Sharafkhaneh A, Lystig T, et al. Acute bronchodilator response does not predict health outcomes in patients with COPD treated with tiotropium [Abstract]. European Respiratory Society 19th Annual Congress; Sep 12-15; Vienna. 2009:[E4353]. [CRS-ID: 4900100000024978]
  • Hanania NA, Sharafkhaneh A, Celli B, Decramer M, Lystig T, Kesten S, et al. Acute bronchodilator responsiveness and health outcomes in COPD patients in the UPLIFT trial. Respiratory Research 2011;12(1):6.
  • Hettle R, Wouters H, Ayres J, Gani R, Kelly S, Lion M, et al. Cost-utility analysis of tiotropium versus usual care in patients with COPD in the UK and Belgium. Respiratory Medicine 2012;106(12):1722-33.
  • Inoue H, Asai Y. UPLIFT (Understanding Potential Long-term Impacts on Function with Tiotropium) study. Respiration and Circulation 2009;57(8):813-8.
  • Janssens W, Liu D, Kesten S, Tashkin DP, Celli BR, Decramer M. Spirometry in UPLIFT®: quality and reproducibility over time [Abstract]. European Respiratory Society 21st Annual Congress; Sep 24-28; Amsterdam. 2011; Vol. 38, issue 55:638s [P3567]. [CRS-ID: 4900100000054049]
  • Janssens W, Liu Y, Liu D, Kesten S, Tashkin DP, Celli BR, et al. Quality and reproducibility of spirometry in COPD patients in a randomized trial (UPLIFT). Respiratory Medicine 2013;107(9):1409-16. [CRS-ID: 4900100000088355]
  • Kesten S, Celli B, Decramer M, Liu D, Tashkin D. Adverse health consequences in COPD patients with rapid decline in FEV1—evidence from the UPLIFT trial. Respiratory Research 2011;12:129.
  • McGarvey L, Magder SA, Liu D, Kesten S, Manuel R, Niewoehner DE. A comparison of the classification of cause of death between site investigators and a mortality adjudication committee in the UPLIFT(R) trial [Abstract]. American Journal of Respiratory and Critical Care Medicine 2010;181(Meeting Abstracts):A5916.
  • McGarvey LP, Magder S, Burkhart D, Kesten S, Liu D, Manuel RC, et al. Cause-specific mortality adjudication in the UPLIFT COPD trial: findings and recommendations. Respiratory Medicine 2012;106(4):515-21.
  • Morice AH, Celli B, Kesten S, Lystig T, Tashkin D, Decramer M. COPD in young patients: a pre-specified analysis of the four-year trial of tiotropium (UPLIFT). Respiratory Medicine 2010;104(11):1659-67.
  • Morice AH, Celli B, Kesten S, Lystig T, Tashkin D, Decramer M. COPD patients under 50 years of age: 4-year follow-up in the UPLIFT trial [Abstract]. Primary Care Respiratory Journal 2010;19(2):A12 [46]. [CRS-ID: 4900100000025536]
  • Osztovits J, Feher J. Safety of tiotropium therapy in chronic obstructive lung diseases (COPD). [Hungarian]. Orvosi Hetilap 2010;151(18):749-50.
  • Paggiaro P, Rossi A. 'Prince Charming'? Some considerations about the decline of FEV1 and on data from UPLIFT study. Rassegna di Patologia dell'Apparato Respiratorio 2009;24(5):278-86.
  • Rodriguez Gonzalez-Moro JM, Lucero S, de Lucas Ramos P. The UPLIFT study: future perspectives. [Spanish]. Archivos de Bronconeumologia 2008;44(Suppl 2):39-48.
  • Rutten-van Molken M, Oostenbrink J, Monz B. EQ-5D discriminates between COPD patients of different severity. European Respiratory Journal 2005;26(Suppl 49):470s. [CRS-ID: 4900100000035648]
  • Rutten-van Mölken MP, Oostenbrink JB, Tashkin DP, Burkhart D, Monz BU. Does quality of life of COPD patients as measured by the JOUReric EuroQol five-dimension questionnaire differentiate between COPD severity stages?. Chest 2006;130(4):1117-28.
  • Tashkin D, Celli B, Decramer M, Burkhart D, Kesten S, Cassino C. Comorbid conditions reported in patients with COPD recruited into a global clinical trial (UPLIFT) [Abstract]. European Respiratory Journal 2005;26(Suppl 49):Abstract No. 4203.
  • Tashkin D, Celli B, Decramer M, Paulwels R, Burkhart D, Kesten S. Regional patterns in the characteristics of patients recruited into a long-term global clinical trial in COPD (UPLIFT) [Abstract]. American Thoracic Society International Conference; May 20-25; San Diego. 2005:[B46] [Poster: J126]. [CRS-ID: 4900100000018885]
  • Tashkin D, Celli B, Kesten S, Lystig T, Decramer M. Effect of tiotropium in men and women with COPD: results of the 4-year UPLIFT trial. Respiratory Medicine 2010;104(10):1495-504.
  • Tashkin D, Celli B, Lystig T, Kesten S, Decramer M. Efficacy of tiotropium in COPD patients with FEV1: 60% participating in the UPLIFT trial [Abstract]. European Respiratory Society Annual Congress, Barcelona, Spain, September 18-22. 2010:[P1186].
  • Tashkin D, Celli B, Senn S, Burkhart D, Kesten S, Menjoge S, et al. A 4-year trial of tiotropium in chronic obstructive pulmonary disease (UPLIFT trial). Revista Portuguesa de Pneumologia 2009;15(1):137-40.
  • Tashkin DP. Impact of tiotropium on the course of moderate-to-very severe chronic obstructive pulmonary disease: the UPLIFT trial. [Review] [51 refs]. Expert Review of Respiratory Medicine 2010;4(3):279-89. [CRS-ID: 4900100000025628]
  • Tashkin DP, Celli B, Burkhart D, Kesten S, Liu D, Mehra S, et al. Long-term efficacy of tiotropium in continuing smokers vs sustained ex-smokers in the UPLIFT trial [Abstract]. American Thoracic Society International JOURerence, May 15-20, San Diego. 2009:A6175 [Poster #201].
  • Tashkin DP, Celli B, Decramer M, Liu D, Burkhart D, Cassino C, et al. Bronchodilator responsiveness in patients with COPD. European Respiratory Journal 2008;31(4):742-50.
  • Tashkin DP, Celli B, Kesten S, Liu D, Decramer M. Reduced reporting of respiratory failure in the UPLIFT(R) trial [Abstract]. American Journal of Respiratory and Critical Care Medicine 2010;181(Meeting Abstracts):A4483.
  • Tashkin DP, Celli B, Kesten S, Lystig T, Mehra S, Decramer M. Long-term efficacy of tiotropium in relation to smoking status in the UPLIFT trial. European Respiratory Journal 2010;35(2):287-94. [CRS-ID: 4900100000025372]
  • Tashkin DP, Celli B, Senn S, Burkhart D, Kesten S, Menjoge S, et al. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. New England Journal of Medicine 2008;359(15):1543-54. [CRS-ID: 4900100000022535]
  • Tashkin DP, Celli BR, Decramer M, Lystig T, Liu D, Kesten S. Efficacy of tiotropium in COPD patients with FEV1 ≥ 60% participating in the UPLIFT® trial. COPD 2012;9(3):289-96.
  • Tashkin DP, Celli BR, Kesten S, Liu D, Decramer M. Cardiovascular adverse events according to GOLD stage in the UPLIFT trial [Abstract]. Chest 2009;136(4):52S-g.
  • Tashkin DP, Celli BR, Kesten S, Lystig T, Mehra S, Decramer M. Efficacy of tiotropium in men and women: 4-year follow-up in the uplift trial [Abstract]. Chest 2009;136(4):24S-h, 25.
  • Tashkin DP, Decramer M, Celli B, Burkhart D, Cassino C, Kesten S. Baseline characteristics according to JOURder in a global respiratory trial [Abstract]. American Thoracic Society International Conference; May 18-23; San Francisco. 2007:Poster #924.
  • Troosters T, Celli B, Kesten S, Liu D, Mehra S, Tashkin D, et al. Effectiveness of combination therapy with tiotropium in COPD. A secondary analysis of the UPLIFT trial [Abstract]. European Respiratory Society 19th Annual Congress; Sep 12-15; Vienna. 2009:[P3808]. [CRS-ID: 4900100000025093]
  • Troosters T, Celli B, Kesten S, Liu D, Tashkin D, Decramer M. Effectiveness of combination therapy with tiotropium in COPD. A secondary analysis of the UPLIFT trial [Abstract]. Primary Care Respiratory Journal 2010;19(2):A13 [49].
  • Troosters T, Celli B, Lystig T, Kesten S, Mehra S, Tashkin DP, et al. Tiotropium as a first maintenance drug in COPD: secondary analysis of the UPLIFT trial. European Respiratory Journal 2010;36(1):65-73.
  • Troosters T, Kesten S, Burkhart D, Celli B, Liu D, Mehra S, et al. Effectiveness of tiotropium as first maintenance drug in patients with COPD. Secondary analysis of the UPLIFT Trial [Abstract]. American Thoracic Society International Conference; May 15-20 San Diego. 2009:A2467.
  • Zaniolo O, Iannazzo S, Pradelli L, Miravitlles M. Pharmacoeconomic evaluation of tiotropium bromide in the long-term treatment of chronic obstructive pulmonary disease (COPD) in Italy. European Journal of Health Economics 2012;13(1):71-80.
Tashkin 2012 {published data only}
  • Doherty D, Tashkin D, Kerwin E, Eduardo Matiz-Bueno C, Shekar T, Banerjee S, et al. Efficacy and safety of mometasone furoate/formoterol in subjects with moderate to very severe chronic obstructive pulmonary disease: results from two phase three 26-week trials [Abstract]. Chest 2011;140(4):535A.
  • Kerwin E, Tashkin D, Matiz-Bueno CE, Doherty D, Shekar T, Banerjee S, et al. Quality of life following 26 weeks of mometasone furoate/formoterol therapy: results from two phase three trials in subjects with moderate to very severe chronic obstructive pulmonary disease [Abstract]. Chest 2011;140(4):558A.
  • Matiz-Bueno CE, Doherty D, Kerwin E, Tashkin D, Shekar T, Banerjee S, et al. The long-term safety characteristics of mometasone furoate/formoterol for the treatment of moderate to very severe chronic obstructive pulmonary disease: pooled findings from two 1-year multicenter clinical trials [Abstract]. Chest 2011;140(4):548A.
  • Tashkin D, Doherty D, Kerwin E, Matiz-Bueno CE, Shekar T, Banerjee S, et al. The effect of mometasone furoate/formoterol combination therapy on chronic obstructive pulmonary disease (COPD) exacerbations: results from two phase three trials in subjects with moderate to very severe COPD [Abstract]. Chest 2011;140(4):549A.
  • Tashkin DP, Doherty DE, Kerwin E, Matiz-Bueno CE, Knorr B, Shekar T, et al. Efficacy and safety characteristics of mometasone furoate/formoterol fumarate fixed-dose combination in subjects with moderate to very severe COPD: findings from pooled analysis of two randomized, 52-week placebo-controlled trials. International Journal of Chronic Obstructive Pulmonary Disease 2012;7:73-86.
  • Tashkin DP, Doherty DE, Kerwin E, Matiz-Bueno CE, Knorr B, Shekar T, et al. Efficacy and safety of a fixed-dose combination of mometasone furoate and formoterol fumarate in subjects with moderate to very severe COPD: results from a 52-week Phase III trial. International Journal of Chronic Obstructive Pulmonary Disease 2012;7:43-55.
To 2011 {published data only}
  • To Y, Nishimura M, Fukuchi Y, Kitawaki T, Okino N, Lassen C, et al. Long-term safety and tolerability of indacaterol versus salmeterol in Japanese COPD patients: a 52-week open-labeled study [Abstract]. Respirology (Carlton, Vic.) 2011;16(Suppl 2):96 [240].
Tonnel 2008 [TIPHON] {published data only}
  • Tonnei AB, Bravo ML, Brun M, Tonnel AB. Clinically significant improvements of health status of COPD patients after 9 months treatment with tiotropium bromide: the TIPHON study [Abstract]. American Thoracic Society International Conference; May 20-25; San Diego. 2005:[B93] [Poster: 302].
  • Tonnei AB, Perez T, Grosbois JM, Bravo ML, Brun M, Tonnel AB. Improvement in HRQoL of COPD patients after 9 months treatment with tiotropium bromide: use of a new scale for daily medical practice [Abstract]. European Respiratory Journal 2005;26(Suppl 49):Abstract No. 1934.
  • Tonnel AB, Perez T, Grosbois JM, Verkindre C, Bravo ML, Brun M. Effect of tiotropium on health-related quality of life as a primary efficacy endpoint in COPD. International Journal of Chronic Obstructive Pulmonary Disease 2008;3(2):301-10.
Trooster 2011 {published data only}
  • Sciurba FC, Siafakas N, Troosters T, Klioze SS, Sutradhar S, Weisman I, et al. The efficacy and safety of tiotropium handihaler, 18 µg, once daily plus PRN salbutamol versus placebo plus PRN salbutamol in COPD subjects naive to maintenance therapy [Abstract]. American Journal of Respiratory and Critical Care Medicine 2011;183(Meeting Abstracts):A1589.
Verhoeven 2002 {published data only}
  • Verhoeven GT, Garrelds IM, Hoogsteden HC, Zijlstra FJ. Effects of fluticasone propionate inhalation on levels of arachidonic acid metabolites in patients with chronic obstructive pulmonary disease. Mediators of Inflammation 2001;10(1):21-6.
  • Verhoeven GT, Hegmans J, Hoogsteden HC, Prins JB. Inhaled fluticasone propionate (FP) reduces the number of inflammatory cells in bronchial biopsies of COPD patients with bronchial hyperresponsiveness (BHR). American Journal of Respiratory and Critical Care Medicine 1998;157(3 Suppl):A798.
  • Verhoeven GT, Hegmans JP, Mulder PG, Bogaard JM, Hoogsteden HC, Prins JB. Effects of fluticasone propionate in COPD patients with bronchial hyperresponsiveness. Thorax 2002;57(8):694-700.
  • Verhoeven GT, Mulder PGH, Bogaard JM, Hoogsteden HC. Inhaled fluticasone propionate (FP) has a significant effect on FEV1 of COPD patients with bronchial hyperresponsiveness (BHR). American Journal of Respiratory and Critical Care Medicine 1998;157(3 Suppl):A799.
  • Verhoeven GT, Wijkhuijs AJ, Hooijkaas H, Hoogsteden HC, Sluiter W. Effect of an inhaled glucocorticoid on reactive oxyJOUR species production by bronchoalveolar lavage cells from smoking COPD patients. Mediators of Inflammation 2000;9(2):109-13.
Vestbo 1999 {published data only}
  • Vestbo J, Sorensen T, Lange P, Brix A, Torre P, Viskum K. Long-term effect of inhaled budesonide in mild and moderate chronic obstructive pulmonary disease: a randomised controlled trial. Lancet 1999;353(9167):1819-23.
  • Vestbo J, Sorensen T, Lange P, Brix A, Torre P, Viskum K. Long-term effect of inhaled budesonide in patients with mild to moderate chronic obstructive lung disease. The Osterbro Study. Ugeskrift for Laeger 2000;162(4):493-7.
Vogelmeier 2008 {published data only}
  • Arievich H, Potena A, Fonay K, Vogelmeier CF, Overend T, Smith J, et al. Formoterol given either alone or together with tiotropium reduces the rate of exacerbations in stable COPD patients [Abstract]. European Respiratory Journal 2006;28(Suppl 50):440s [P2514].
  • Vogelmeier C, Kardos P, Harari S, Gans SJ, Stenglein S, Thirlwell J. Formoterol mono- and combination therapy with tiotropium in patients with COPD: a 6-month study. Respiratory Medicine 2008;102(11):1511-20.
  • Vogelmeier CF, Harari SA, Fonay K, Beier J, Overend T, Till D, et al. Formoterol and tiotropium both improve lung function in stable COPD patients with some additional benefit when given together [Abstract]. European Respiratory Journal 2006;28(Suppl 50):429s [P2506].
Vogelmeier 2011 [POET] {published data only}
  • Beeh KM, Hederer B, Glaab T, Müller A, Rutten-van Moelken M, Kesten S, et al. Study design considerations in a large COPD trial comparing effects of tiotropium with salmeterol on exacerbations. International Journal of Chronic Obstructive Pulmonary Disease 2009;4(1):119-25.
  • Beeh KM, Vogelmeier C, Rutten-van Mölken M, Rabe KF, Glaab T, et al. Tiotropium vs salmeterol in GOLD II and maintenance-naive COPD patients: subgroup analyses of POET-COPD™ trial [Abstract]. European Respiratory Society 21st Annual Congress; Sep 24-28; Amsterdam. 2011; Vol. 38, issue 55:20s [P251].
  • Fabbri LM, Vogelmeier C, Rutten-van Mölken MPMH, Rabe KF, Glaab T, Ruhmkorf F, et al. Baseline characteristics of patients with frequent exacerbations in the POET-COPD trial [Abstract]. European Respiratory Society 21st Annual Congress; Sep 24-28; Amsterdam. 2011; Vol. 38, issue 55:49s [405]. [CRS-ID: 4900100000053958]
  • Glaab T, Vogelmeier C, Schmidt H, Rutten-van Mölken M, Beeh KM, Rabe K, et al. Seasonal distribution of exacerbations in the POET-COPD study [Abstract]. American Journal of Respiratory and Critical Care Medicine 2011;183(Meeting Abstracts):A3726. [CRS-ID: 4900100000053911]
  • Hoogendoorn M, Al MJ, Beeh KM, Bowles D, Graf von der Schulenburg JM, Lungershausen J, et al. Cost-effectiveness of tiotropium versus salmeterol: the POET-COPD trial. European Respiratory Journal 2013;41(3):556-64. [CRS-ID: 4900100000076226]
  • Rabe KF, Fabbri LM, Vogelmeier C, Kögler H, Schmidt H, Beeh KM, et al. Seasonal distribution of COPD exacerbations in the prevention of exacerbations with tiotropium in COPD trial. Chest 2013;143(3):711-9.
  • Rutten-van Mölken MPMH, Fabbri LM, Rabe KF, Kögler H, Glaab T, Schmidt H, et al. Do exacerbation outcomes in the POET-COPD trial differ between regions? [Abstract]. European Respiratory Society 21st Annual Congress; Sep 24-28; Amsterdam. 2011; Vol. 38, issue 55:82s [P559]. [CRS-ID: 4900100000053963]
  • Vogelmeier C, Fabbri LM, Rabe KF, Beeh KM, Schmidt H, Metzdorf N, et al. Effect of tiotropium vs. salmeterol on exacerbations: GOLD II and maintenance therapy naive patients. Respiratory Medicine 2013;107(1):75-83.
  • Vogelmeier C, Hederer B, Glaab T, Schmidt H, Rutten-van Mölken MP, Beeh KM, et al. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. New England Journal of Medicine 2011;364(12):1093-103.
  • Vogelmeier C, Rabe K, Beeh KM, Glaab T, Schmidt H, Rutten-van Molken M, et al. Tiotropium reduces exacerbations versus salmeterol irrespective of baseline ICS treatment in the POET-COPD study [Abstract]. American Journal of Respiratory and Critical Care Medicine 2011;183(Meeting Abstracts):A1600.
  • Vogelmeier CF, Beeh KM, Rutten-van Molken M, Glaab T, Schmidt H, Hederer B. Baseline characteristics according to gender in a large exacerbations trial [Abstract]. American Journal of Respiratory and Critical Care Medicine 2010;181(Meeting Abstracts):A4495.
Wedzicha 2008 [INSPIRE] {published data only}
  • Calverley P, Stockley R, Seemungal T, Hagan G, Wedzicha J. Adverse events and mortality in the INSPIRE study (investigating new standards for prophylaxis in reduction of exacerbations) [Abstract]. European Respiratory Journal 2007;30(Suppl 51):125s [P847].
  • Calverley PM, Stockley RA, Seemungal TA, Hagan G, Willits LR, Riley JH, et al. Reported pneumonia in patients with COPD: findings from the INSPIRE study. Chest 2011;139(3):505-12.
  • GlaxoSmithKline. Multicentre, randomised, double-blind, double dummy, parallel group, 104-week study to compare the effect of the salmeterol/fluticasone propionate combination product (SERETIDE*) 50/500mcg delivered twice daily via the DISKUS*/ACCUHALER* inhaler with tiotropium bromide 18 mcg delivered once daily via the HandiHaler inhalation device on the rate of health care utilisation exacerbations in subjects with severe chronic obstructive pulmonary disease (COPD). http://www.gsk-clinicalstudyregister.com/ (accessed 6 March 2014).
  • Seemungal T, Stockley R, Calverley P, Hagan G, Wedzicha J. Effect of salmeterol/fluticasone propionate versus tiotropium bromide on exacerbations: the INSPIRE study (investigating new standards for prophylaxis in reduction of exacerbations) [Abstract]. European Respiratory Journal 2007;30(Suppl 51):688s [E4055].
  • Seemungal T, Stockley R, Calverley P, Hagan G, Wedzicha JA. Investigating new standards for prophylaxis in reduction of exacerbations—the INSPIRE study methodology. Journal of Chronic Obstructive Pulmonary Disease 2007;4(3):177-83.
  • Stockley R, Calverley P, Seemungal T, Hagan G, Wedzicha J. Effect of salmeterol/fluticasone propionate versus tiotropium bromide on withdrawal rate, health status, lung function and mortality INSPIRE (investigating new standards for prophylaxis in reduction of exacerbations study) [Abstract]. European Respiratory Journal 2007;30(Suppl 51):34s [388].
  • Wedzicha J, Stockley R, Seemungal T, Hagan G, Calverley P. The INSPIRE study: effect of salmeterol/fluticasone propionate versus tiotropium bromide on COPD exacerbations [Abstract]. Respirology (Carlton, Vic.) 2007;12(Suppl 4):A112.
  • Wedzicha JA, Calverley PM, Seemungal TA, Hagan G, Ansari Z, Stockley RA, et al. The prevention of chronic obstructive pulmonary disease exacerbations by salmeterol/fluticasone propionate or tiotropium bromide. American Journal of Respiratory and Critical Care Medicine 2008;177(1):19-26.
Zheng 2006 {published data only}
  • GlaxoSmithKline. A multi-centre, randomised, double-blind, parallel group study to investigate the efficacy and safety of the salmeterol/fluticasone propionate combination at a strength of 50/500 µg BD, compared with placebo via Accuhaler, added to usual chronic obstructive pulmonary disease (COPD) therapy, in subjects with COPD for 24 weeks. http://www.gsk-clinicalstudyregister.com (accessed 6 March 2014).
  • Zheng J, Zhong N, Yang L, Wu Y, Chen P, Wen Z, et al. The efficacy and safety of fluticasone propionate 500 mg/salmeterol 50 mg combined via diskus/accuhaler in Chinese patients with chronic obstructive pulmonary disease (COPD) [Abstract]. Chest 2006;130(4 Suppl):182s.
  • Zheng JP, Yang L, Wu YM, Chen P, Wen ZG, Huang WJ, et al. The efficacy and safety of combination salmeterol (50 microg)/fluticasone propionate (500 microg) inhalation twice daily via accuhaler in Chinese patients with COPD. Chest 2007;132(6):1756-63.
  • Zhong N, Zheng J, Yang L, Wu Y, Chen P, Wen Z, et al. The efficacy and safety of salmeterol 50 µg/fluticasone propionate 500 µg combined via accuhaler in Chinese patients with chronic obstructive pulmonary disease [Abstract]. Respirology (Carlton, Vic.) 2006;11(Suppl 5):A150 [PS-3-9].
Zhong 2012 {published data only}
  • Zhong N, Zheng J, Wen F, Yang L, Chen P, Xiu Q, et al. Efficacy and safety of budesonide/formoterol via a dry powder inhaler in Chinese patients with chronic obstructive pulmonary disease. Current Medical Research and Opinion 2012;28(2):257-65.
  • Zhong N, Zheng J, Wen F, Yang L, Chen P, Xiu Q, et al. Efficacy and safety of inhalation of budesonide/formoterol via turbuhaler in Chinese patients with chronic obstructive pulmonary disease [Abstract]. Chest 2011;140(4):5225A.

References to studies excluded from this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to ongoing studies
  4. Additional references
Aalbers 2002 {published data only}
  • Aalbers R, Ayres J, Backer V, Decramer M, Lier PA, Magyar P, et al. Formoterol in patients with chronic obstructive pulmonary disease: a randomized, controlled, 3-month trial. European Respiratory Journal 2002;19(5):936-43. [: 0903-1936]
  • Sybrecht GW. Inhaled formoterol was an effective and safe treatment in COPD patients. European Respiratory Society 9th Annual Congress; Oct 9-13; Madrid. 1999:2510.
ACCORD II 2012 {published data only}
  • D'Urzo A, Kerwin E, Donohue J, Rennard S, Gelb A, Lakkis H, et al. Effects of twice-daily aclidinium bromide in COPD patients: a long-term extension of ACCORD-COPD I [Abstract]. European Respiratory Society 22nd Annual Congress; Sep 1-5; Vienna. 2012; Vol. 40, issue Suppl 56:528s [P2890]. [ACCORD: COPD II]
  • D'Urzo A, Kerwin E, Rennard S, He T, Garcia Gil E, Caracta C. Improvements in lung function with twice-daily aclidinium bromide: results of a long-term, phase 3 trial in patients with chronic obstructive pulmonary disease [Abstract]. Chest 2012;142(4):740A. [ACCORD-COPD: 1 SID - NCT00891462]
  • D'Urzo AD, Kerwin EM, Donohue JF, Rennard SI, Gelb AF, Lakkis H. Long-term extension study of ACCORD COPD I: effects of two doses of twice-daily aclidinium bromide in COPD patients [Abstract]. American Journal of Respiratory and Critical Care Medicine 2012;185(Meeting Abstracts):A2913. [ACCORD: COPD II]
  • Kerwin EM, D'Urzo AD, Gelb AF, Lakkis H, Garcia Gil E, Caracta CF, et al. Efficacy and safety of a 12-week treatment with twice-daily aclidinium bromide in COPD patients (ACCORD COPD I). COPD 2012;9(2):90-101. [ACCORD-COPD: 1 SID - NCT00891462]
Ambrosino 2008 {published data only}
  • Ambrosino N, Foglio K, Balzano G, Paggiaro PL, Lessi P, Kesten S. Tiotropium and exercise training in COPD patients: effects on dyspnea and exercise tolerance. International Journal of Chronic Obstructive Pulmonary Disease 2008;3(4):771-80.
Auffarth 1991 {published data only}
  • Auffarth B, Postma DS, de Monchy JG, van der Mark TW, Boorsma M, Koeter GH. Effects of inhaled budesonide on spirometric values, reversibility, airway responsiveness, and cough threshold in smokers with chronic obstructive lung disease. Thorax 1991;46(5):372-7.
Barnes 2006 {published data only}
  • Barnes NC, Qiu Y, Pavord I, Parker D, Johnson M, Thompson M, et al. Salmeterol/fluticasone propionate (SFC): anti-inflammatory effects in COPD [Abstract]. American Thoracic Society International Conference; May 20-25; San Diego. 2005:B93 [Poster 320].
  • Barnes NC, Qiu Y-S, Pavord ID, Parker D, Davis PA, Zhu J, et al. Antiinflammatory effects of salmeterol/fluticasone propionate in chronic obstructive lung disease. American Journal of Respiratory and Critical Care Medicine 2006;173(7):736-43.
  • GlaxoSmithKline. A 13-week, double-blind, parallel-group, multicentre study to compare the bronchial anti-inflammatory activity of the combination of salmeterol/fluticasone propionate (SERETIDE™/ADVAIR™/VIANI™) 50/500 mcg twice daily compared with placebo twice daily in patients with chronic obstructive pulmonary disease. http://www.gsk-clinicalstudyregister.com/ (accessed 10 June 2013). [GSK: SCO30005]
  • Qiu Y, Parker D, Barnes NC, Johnson M, Pavord L, et al. The effect of salmeterol/fluticasone propionate (SFC) on eosinophils and mast cells in COPD [Abstract]. American Thoracic Society International Conference; May 20-25; San Diego. 2005:A43 [Poster F36].
  • Qiu YS, Davis P, Zhu J, Peachey L, Barnes NC, Pavord I, et al. Anti-inflammatory effects of salmeterol/fluticasone propionate (SFC) on airway T-lymphocyte populations in COPD. European Respiratory Journal 2005;26 Suppl 49:203s.
  • Qiu YS, Davis P, Zhu J, Peachey L, Barnes NC, Pavord I, et al. Effects of salmeterol/fluticasone propionate (SFC) on airway inflammation in COPD: a placebo-controlled study of endobronchial biopsies. European Respiratory Journal 2005;26 Suppl 49:203s.
  • Zhu J, Qiu Y, Barnes NC, Johnson M, Pavord I, Jeffery PK. The effect of salmeterol/fluticasone propionate (SFC) on pro-inflammatory gene expression in COPD [Abstract]. American Thoracic Society International Conference; May 20-25; San Diego. 2005:A43 [Poster F6].
Beeh 2006 {published data only}
  • Beeh KM, Beier J, Buhl R, Gerken FMN. Efficacy of tiotropium (Spiriva) in patients with COPD switched from previous treatment with short-acting anticholinergics [Abstract]. American Thoracic Society International Conference; May 19-21; San Diego. 2006:A113 [Poster J27].
  • Beeh KM, Beier J, Buhl R, Stark-Lorenzen P, Gerken F, Metzdorf N, et al. Efficacy of tiotropium bromide (Spiriva) in patients with chronic-obstructive pulmonary disease (COPD) of different severities [Wirksamkeit von Tiotropiumbromid (Spiriva) bei verschiedenen Schweregraden derchronisch−obstruktiven Lungenerkrankung (COPD)]. Pneumologie 2006;60(6):341-6. [CTG: NCT00274573]
  • Beeh KM, Beier J, Buhl R, Strak-Lorenzen P, Gerken F, Metzdorf N. Efficacy of tiotropium in patients with mild to moderate COPD [Abstract]. American Thoracic Society 100th international conference; May 21-26; Orlando. 2004:P513.
  • Boehringer Ingelheim. Acute and long-term effects of once daily oral inhalation of tiotropium 18 mcg dry powder inhalation capsules in a placebo controlled parallel group design study in patients with chronic obstructive pulmonary disease (COPD) of different severity. www.trials.boehringer-ingelheim.com (accessed 6 March 2014). [trial number: 205.257]
Bogdan 2011 {published data only}
  • Bogdan M, Aizawa H, Fukuchi Y, Mishima M, Nishimura M, Ichinose M. Efficacy and safety of inhaled formoterol 4.5 and 9 microg twice daily in Japanese and European COPD patients: phase III study results. BMC Pulmonary Medicine 2011;11(1):51. [: 1471-2466]
  • Bogdan MA, Kudo T, Umemiya M. Efficacy and safety of inhaled formoterol 4.5 and 9 mcg twice daily in Japanese and European patients with COPD: results of a Phase III study [Abstract]. American Journal of Respiratory and Critical Care Medicine 2010;181:A4494.
  • Ichinose M, Aizawa H, Fukuchi Y, Mishima M, Nishimura M, Bogdan M. Patient-reported outcomes (PROs) and reliever use in Japanese and European patients with chronic obstructive pulmonary disease receiving formoterol 4.5 and 9 microg twice daily: results of the OCEAN phase III study [Abstract]. European Respiratory Society 20th Annual Congress; Sep 18-22; Barcelona. 2010.
Bourbeau 2007 {published data only}
  • Bourbeau J, Christodoulopoulos P, Maltais F, Yamauchi Y, Olivenstein R, Hamid Q. Effect of salmeterol/fluticasone propionate on airway inflammation in COPD: a randomised controlled trial. Thorax 2007;62(11):938-43.
Briggs 2005 {published data only}
  • Briggs D Jr, Covelli H, Lapidus R, Bhattacharya S, Kesten S, Cassino C. Improved daytime spirometric efficacy of tiotropium compared to salmeterol in COPD patients [Abstract]. American Thoracic Society 100th international conference; May 21-26; Orlando. 2004:C22 Poster 511.
  • Briggs DD Jr, Covelli H, Lapidus R, Bhattycharya S, Kesten S, Cassino C. Improved daytime spirometric efficacy of tiotropium compared with salmeterol in patients with COPD. Pulmonary Pharmacology and Therapeutics 2005;18(6):397-404.
  • Brusasco V, Menjoge SS, Kesten S. Flow and volume responders over 12 hours following treatment with tiotropium or salmeterol in patients with COPD [Abstract]. American Thoracic Society International Conference; May 19-21; San Diego. 2006:A110 [Poster J10].
  • Langley J, Briggs D Jr, Bhattacharya S, Kesten S, Cassino C. Spirometric outcomes of COPD patients with tiotropium compared with salmeterol according to previous maintenance long acting beta-agonist use [Abstract]. European Respiratory Journal 2004;24(Suppl 48):289s.
Brightling 2005 {published data only}
  • Brightling CE, McKenna S, Hargadon B, Birring S, Green R, Siva R, et al. Sputum eosinophilia and the short term response to inhaled mometasone in chronic obstructive pulmonary disease. Thorax 2005;60(3):193-8.
Burl 2011 {published data only}
  • Buhl R, Dunn LJ, Disdier C, Lassen C, Amos C, Henley M, et al. Blinded 12-week comparison of once-daily indacaterol and tiotropium in COPD. European Respiratory Journal 2011;38:797-803.
  • Dunn LJ, Buhl R, Lassen C, Henley M, Kramer B. Blinded 12-week comparison of once-daily indacaterol and tiotropium in COPD [Abstract]. Chest 2010;138:719A.
Cazzola 2007 {published data only}
  • Cazzola M, Ando F, Santus P, Ruggeri P, Di Marco F, Sanduzzi A, et al. A pilot study to assess the effects of combining fluticasone propionate/salmeterol and tiotropium on the airflow obstruction of patients with severe-to-very severe COPD. Pulmonary Pharmacology and Therapeutics 2007;20(5):556-61.
  • D'Amato M, Ando F, Santus P, Ruggeri P, Di Marco F, Cazzola M. Clinical effects of adding fluticasone propionate/salmeterol (FSC) and tiotropium (TIO) in severe-to-very severe COPD [Abstract]. European Respiratory Journal 2005;26(Suppl 49):Abstract No. 218.
Choudhury 2005 {published data only}
  • Choudhury AB, Dawson CM, Kilvington HE, Eldridge HE, James WY, Wedzicha JA, et al. Withdrawal of inhaled corticosteroids in people with chronic obstructive pulmonary disease (COPD) in primary care—a randomised controlled trial [Abstract]. European Respiratory Journal 2005;26(Suppl 49):Abstract No. 1328.
Covelli 2005 {published data only}
  • Boehringer Ingelheim. Efficacy and safety (including 24-hour holter monitoring) of tiotropium inhalation capsules in patients with chronic obstructive pulmonary disease (a 12-week, parallel group, randomized, placebo-controlled, double-blind study). www.trials.boehringer-ingelheim.com (accessed 6 March 2014). [trial number: 205.284]
  • Covelli H, Bhattacharya S, Cassino C, Conoscenti C, Kesten S. Absence of electrocardiographic findings and improved function with once-daily tiotropium in patients with chronic obstructive pulmonary disease. Pharmacotherapy 2005;25(12):1708-18. [CTG: NCT00239460]
  • Kesten S, Cassino C, Conoscenti C. Absence of electrocardiographic findings with daily tiotropium in patients with chronic obstructive pulmonary disease [Abstract]. Chest 2004;126(4 Suppl):837S.
Culpitt 1999 {published data only}
  • Culpitt SV, Maziak W, Loukidis S, Nightingale JA, Matthews JL, Barnes PJ. Effect of high dose inhaled steroid on cells, cytokines, and proteases in induced sputum in chronic obstructive pulmonary disease. American Journal of Respiratory and Critical Care Medicine 1999;160(5 Pt 1):1635-9.
Dahl 2001 {published data only}
  • Dahl R, Greefhorst AP, Byrne AM. Onset of inhaled formoterol compared to ipratropium bromide in patients with COPD. European Respiratory Journal 2000;16(Suppl 31):5s.
  • Dahl R, Greefhorst APM, Nowak D, Nonikov V, Byrne A, Colacchio C, et al. Comparison of the efficacy and safety of inhaled formoterol and ipratropium bromide in patients with COPD. American Journal of Respiratory and Critical Care Medicine 2000;161(Suppl 3):A489.
  • Dahl R, Greefhorst APM, Thomson MH, Till D. Formoterol (Foradil®) improves lung function and quality of life (QOL) parameters in patients with reversible or poorly reversible COPD. American Journal of Respiratory and Critical Care Medicine 2001;163(Suppl 5):A280.
  • Dahl R, Greefhorst LA, Nowak D, Nonikov V, Byrne AM, Thomson MH, et al. Inhaled formoterol dry powder versus ipratropium bromide in chronic obstructive pulmonary disease. American Journal of Respiratory and Critical Care Medicine 2001;164(5):778-84. [: 1073-449X]
  • Dahl R, Kristufek P, Greefhorst APM, Amgott TR, Della Cioppa G, Thompson MH. The cardiac safety profile of formoterol dry powder is similar to placebo in patients with COPD. European Respiratory Journal 2000;16(Suppl 31):51s.
  • Greefhorst APM, Dahl R, Nowak D, Nonikov V, Byrne A, Colacchio C, et al. Effect of inhaled formoterol and ipratropium bromide on quality of life, "bad days" and exacerbations in patients with COPD. American Journal of Respiratory and Critical Care Medicine 2000;161(Suppl 3):A490.
  • Greefhorst APM, Dahl R, Nowak D, Nonikov V, Colacchio C, Byme AM. Formoterol dry powder improves the quality of life of patients with COPD whereas the effect of ipratropium bromide is similar to placebo. European Respiratory Journal 2000;16(Suppl 31):51s.
  • Greefhorst APM, Thomson MH, Byrne A, Till D. The efficacy of formoterol in patients with chronic obstructive pulmonary disease (COPD) is not influenced by concomitant corticosteroid use. European Respiratory Journal 2001;18(Suppl 33):515s.
  • Hogan TJ, Geddes R, Gonzalez ER. An economic assessment of inhaled formoterol dry powder versus ipratropium bromide pressurized metered dose inhaler in the treatment of chronic obstructive pulmonary disease. Clinical Therapeutics 2003;25(1):285-97. [: 0149-2918]
Dahl 2013 [BEACON] {published data only}
  • Dahl R, Jadayel D, Alagappan VKT, Chen H, Banerji D. Efficacy and safety of QVA149 compared to the concurrent administration of its monocomponents indacaterol and glycopyrronium: the BEACON study. International Journal of Chronic Obstructive Pulmonary Disease 2013;8:501-8.
Dawber 2005 {published data only}
  • Dawber F, Tandy D, Haussermann S, Betz R. Efficacy of salmeterol/fluticasone propionate 50/500mcg bd versus tiotropium on lung function and mucociliary clearance in COPD patients [Abstract]. Respirology (Carlton, Vic.) 2005;10(Suppl 3):A99.
Derenne 1995 {published data only}
  • Derenne JP. Effects of high dose inhaled beclomethasone on the rate of decline in FEV1 in patients with chronic obstructive pulmonary disease: results of a 2 years prospective multicentre study. American Journal of Respiratory and Critical Care Medicine 1995;151(4):A463. [CRS-ID: 4900100000023687]
Dransfield 2013 {published data only}
  • Dransfield MT, Bourbeau J, Jones PW, Hanania NA, Mahler DA, Vestbo J, et al. Once-daily inhaled fluticasone furoate and vilanterol versus vilanterol only for prevention of exacerbations of COPD: two replicate double-blind, parallel-group, randomised controlled trials. The Lancet Respiratory Medicine 2013;1(3):210-23.
FCO30002 {published data only}
  • GlaxoSmithKline. A multicentre, randomised, placebo-controlled, double-blind comparison with 3 parallel groups to investigate the efficacy and safety of inhaled glucocorticoid fluticasone (500 μg bd via Diskus™) vs. oral glucocorticoid therapy vs. placebo in subjects with chronic obstructive airway disease (COPD) under therapy with Salmeterol (50 μg bd). http://www.gsk-clinicalstudyregister.com/ (accessed 6 March 2014). [GSK: FCO30002]
Ferreira 2001 {published data only}
  • Ferreira IM, Hazari MS, Gutierrez C, Zamel N, Chapman KR. Exhaled nitric oxide and hydrogen peroxide in patients with chronic obstructive pulmonary disease: effects of inhaled beclomethasone. American Journal of Respiratory and Critical Care Medicine 2001;164(6):1012-5.
Ferreira 2003 {published data only}
  • Ferreira IM, Sandrini A, Zamel N, Balter M, Chapman KR. Effects of inhaled fluticasone propionate (FP) on exhaled nitric oxide (ENO), functional exercise capacity and quality of life in stable patients with COPD. American Thoracic Society 99th International Conference; May 16-21; Seattle. 2003:B024 Poster 404.
Freeman 2007 {published data only}
  • Freeman D. A randomised, double-blind, parallel group, 12 week study, comparing the effect of once daily tiotropium lactose capsule with placebo in patients with chronic obstructive pulmonary disease (COPD), naive to anticholinergic agents in addition to receiving their usual COPD care. www.trials.boehringer-ingelheim.com (accessed 6 March 2014). [trial number: 205.276]
  • Freeman D, Lee A, Price D. Efficacy and safety of tiotropium in COPD patients in primary care—the SPiRiva Usual CarE (SPRUCE) study. Respiratory Research 2007;8:45. [CTG: NCT00274079]
  • Freeman D, Sarno M, White L, Lee A, Price D. Spruce: tiotropium in UK primary care [Abstract]. Thorax 2004;59(Suppl II):ii100.
  • Price D, Sarno M, Lee A, Freeman D. SPiRiva usual carE—SPRUCE—tiotropium in a UK primary care COPD population other regular inhaled treatment [Abstract]. American Thoracic Society International Conference; May 20-25; San Diego. 2005:[A43] [Poster: F26].
Fukuchi 2013 {published data only}
Guenette 2011 {published data only}
  • Guenette JA, Raghavan N, Harris-McAllister V, Preston ME, Webb KA, O'Donnell DE. Effect of adjunct fluticasone propionate on airway physiology during rest and exercise in COPD. Respiratory Medicine 2011;105(12):1836-45. [1532-3064: (Electronic)]
Hanrahan 2008 {published data only}
  • Baumgartner RA, Hanania NA, Calhoun WJ, Sahn SA, Sciarappa K, Hanrahan JP. Nebulized arformoterol in patients with COPD: a 12-week, multicenter, randomized, double-blind, double-dummy, placebo- and active-controlled trial. Clinical Therapeutics 2007;29(2):261-78.
  • Grogan DR, Hanrahan JP, Morganroth J, Cheng H, Baumgartner RA. Arrhythmias in COPD: Holter monitoring results from 2 arformoterol pivotal trials [Abstract]. American Thoracic Society International Conference; May 18-23; San Francisco. 2007:Poster 413.
  • Hanrahan JP, Grogan DR, Baumgartner RA, Wilson A, Cheng H, Zimetbaum PJ, et al. Arrhythmias in patients with chronic obstructive pulmonary disease (COPD): occurrence frequency and the effect of treatment with the inhaled long-acting beta2-agonists arformoterol and salmeterol. Medicine 2008;87(6):319-28.
  • Hanrahan JP, Hanania NA, Calhoun WJ, Sahn SA, Sciarappa K, Baumgartner RA. Effect of nebulized arformoterol on airway function in COPD: results from two randomized trials. Journal of Chronic Obstructive Pulmonary Disease 2008;5(1):25-34.
  • Hanrahan JP, Kerwin E, Cheng H, Grogan DR, Baumgartner RA. Arformoterol in COPD safety results from two pooled phase 3 trials [Abstract]. European Respiratory Journal 2006;28(Suppl 50):428s [P2500].
  • Hanrahan JP, Sahn SA, Busse WW, Sciarappa K, Baumgartner RA. Efficacy of nebulized arformoterol: a long acting B2 adrenergic bronchodilator in patients with COPD [abstract]. European Respiratory Journal 2006;28(Suppl 50):215s [P1276].
  • Hanrahan JP, Sahn SA, Fogarty CM, Sciarappa K, Baumgartner RA. Efficacy and safety of arformoterol in COPD: a prospective phase 3 clinical trial [Abstract]. American Thoracic Society International Conference; May 19-21; San Diego. 2006:A847 Poster 509.
  • Hanrahan JP, Smith WB, Sciarappa K, McVicar WK, Baumgartner RA. Efficacy and safety of nebulized arformoterol in COPD: a prospective, phase III clinical trial [Abstract]. Chest 2006;130(4):181s.
  • Sciurba FC, Baumgartner RA, Sciarappa K, Benzo RP, Hanrahan JP. Degree of exercise limitation in COPD: impact on 6 minute walk in response to long acting beta agonist (LABA) treatment [Abstract]. European Respiratory Journal 2007;30(Suppl 51):76s [P596].
  • Sepracor. A double-blind, double-dummy, randomized, placebo- and active-controlled, multicenter, parallel group study of (R,R)-formoterol in the treatment of subjects with chronic obstructive pulmonary disease. www.clinicaltrials.gov (accessed 20 November 2012). [clinicaltrials.gov: NCT00064402; clinicaltrials.gov: NCT00064415]
Hattotuwa 2002 {published data only}
  • Gizycki MJ, Hattotuwa KL, Barnes N, Jeffery PK. Effects of fluticasone propionate on inflammatory cells in COPD: an ultrastructural examination of endobronchial biopsy tissue. Thorax 2002;57(9):799-803.
  • Hattotuwa KL, Gizycki MJ, Ansari TW, Jeffery PK, Barnes NC. The effects of inhaled fluticasone on airway inflammation in chronic obstructive pulmonary disease. American Journal of Respiratory and Critical Care Medicine 2002;165(12):1592-9.
Johansson 2008 {published data only}
  • Johansson G. A 12-week, double-blind, randomised, parallel-group, multi-centre study evaluating the efficacy of tiotropium versus placebo in patients with mild COPD according to Swedish guidelines (SPIRIMILD). www.trials.boehringer-ingelheim.com (accessed 6 March 2014). [trial number: 205.281]
  • Johansson G, Lindberg A, Romberg K, Nordstrom L, Gerken F, Roquet A. Bronchodilator efficacy of tiotropium in patients with mild COPD [Abstract]. European Respiratory Journal 2006;28(Suppl 50):616s [E3614].
  • Johansson G, Lindberg A, Romberg K, Nordstrom L, Gerken F, Roquet A. Bronchodilator efficacy of tiotropium in patients with mild to moderate COPD. Primary Care Respiratory Journal 2008; Vol. 17, issue 3:169-75. [CTG: NCT00144196]
John 2005 {published data only}
  • John M, Bosse S, Oltmanns U, Schumacher A, Witt C. Effects of inhaled HFA beclomethasone on pulmonary function and symptoms in patients with chronic obstructive pulmonary disease. Respiratory Medicine 2005;99(11):1418-24.
  • John M, Bosse S, Schumacher A, Oltmanns U, Witt C. Effects of inhaled beclomethasone HFA 134 (qvar/ventoiair) on health related quality of life in patients with chronic obstructive pulmonary disease [Abstract]. American Thoracic Society International Conference; May 20-25; San Diego. 2005:Poster A43.
Kerstjens 1992 {published data only}
  • Kaptein AA, Brand PL, Dekker FW, Kerstjens HA, Postma DS, Sluiter HJ. Quality-of-life in a long-term multicentre trial in chronic nonspecific lung disease: assessment at baseline. The Dutch CNSLD Study Group. European Respiratory Journal 1993;6(10):1479-84.
  • Kerstjens HA, Brand PL, Quanjer PH, van der Bruggen-Bogaarts BA, Koeter GH, Postma DS. Variability of bronchodilator response and effects of inhaled corticosteroid treatment in obstructive airways disease. Dutch CNSLD Study Group. Thorax 1993;48(7):722-9.
  • Kerstjens HA, Brand PL, de Jong PM, Koeter GH, Postma DS. Influence of treatment on peak expiratory flow and its relation to airway hyperresponsiveness and symptoms. The Dutch CNSLD Study Group. Thorax 1994;49(11):1109-15.
  • Kerstjens HA, Overbeek SE, Schouten JP, Brand PL, Postma DS. Airways hyperresponsivenes, bronchodilator response, allergy and smoking predict improvement in FEV1 during long-term inhaled corticosteroid treatment. Dutch CNSLD Study Group. European Respiratory Journal 1993;6(6):868-76.
  • Kerstjens HA, Postma DS, van Doormaal JJ, van Zanten AK, Brand PL, Dekhuijzen PN, et al. Effects of short-term and long-term treatment with inhaled corticosteroids on bone metabolism in patients with airways obstruction. Dutch CNSLD Study Group. Thorax 1994;49(7):652-6.
  • Kerstjens HA, Schouten JP, Brand PL, Schoonbrood DF, Sterk PJ, Postma DS. Importance of total serum IgE for improvement in airways hyperresponsiveness with inhaled corticosteroids in asthma and chronic obstructive pulmonary disease. The Dutch CNSLD Study Group. American Journal of Respiratory and Critical Care Medicine 1995;151(2 Pt 1):360-8.
  • Kerstjens HAM, Brand PLP, Hughes MD, Robinson NJ, Postma DS, Sluiter HJ, et al. A comparison of bronchodilator therapy with or without inhaled corticosteroid therapy for obstructive airways disease. New England Journal of Medicine 1992;327(20):1413-9.
  • Overbeek SE, Kerstjens HA, Bogaard JM, Mulder PG, Postma DS. Is delayed introduction of inhaled corticosteroids harmful in patients with obstructive airways disease (asthma and COPD)? The Dutch CNSLD Study Group. The Dutch Chronic Nonspecific Lung Disease Study Groups. Chest 1996;110(1):35-41.
  • Rutten-van Molken MP, Van Doorslaer EK, Jansen MC, Kerstjens HA, Rutten FF. Costs and effects of inhaled corticosteroids and bronchodilators in asthma and chronic obstructive pulmonary disease. American Journal of Respiratory and Critical Care Medicine 1995;151(4):975-82.
  • van Grunsven PM, van Schayck CP, Derenne JP, Kerstjens HA, Renkema TE, Postma DS, et al. Long term effects of inhaled corticosteroids in chronic obstructive pulmonary disease: a meta-analysis. Thorax 1999;54(1):7-14.
Kerwin 2013 {published data only}
  • Kerwin EM, Scott-Wilson C, Sanford L, Rennard S, Agusti A, Barnes N, et al. A randomised trial of fluticasone furoate/vilanterol (50/25 mug; 100/25 mug) on lung function in COPD. Respiratory Medicine 2013;107(4):560-9.
Llewellyn-Jones 1996 {published data only}
  • Llewellyn-Jones CG, Harris TA, Stockley RA. Effect of fluticasone propionate on sputum of patients with chronic bronchitis and emphysema. American Journal of Respiratory and Critical Care Medicine 1996;153(2):616-21.
Loppow 2001 {published data only}
  • Loppow D, Schleiss MB, Kanniess F, Taube C, Jorres RA, Magnussen H. In patients with chronic bronchitis a four week trial with inhaled steroids does not attenuate airway inflammation. Respiratory Medicine 2001;95(2):115-21.
Lung Health Study 2000 {published data only}
  • Anthonisen NR, Connett JC, Murray RP. Smoking and lung function of Lung Health Study participants after 11 years. American Journal of Respiratory and Critical Care Medicine 2002;166(5):675-9.
  • Eichenhorn MS, Wise RA, Madhok TC, Gerald LB, Bailey WC, Tashkin DP, et al. Lack of long-term adverse adrenal effects from inhaled triamcinolone: Lung Health Study II. Chest 2003;124(1):57-62.
  • Lung Health Study Research Group. Effect of inhaled triamcinolone on the decline in pulmonary function in chronic obstructive pulmonary disease. New England Journal of Medicine 2000;343(26):1902-9.
  • Scanlon PD, Connett JE, Wise RA, Tashkin DP, Madhok T, Skeans M, et al. Loss of one density with inhaled triamcinolone in Lung Health Study II. American Journal of Respiratory and Critical Care Medicine 2004;170(12):1302-9.
  • Tashkin DP, Murray HE, Skeans M, Murray RP. Skin manifestations of inhaled corticosteroids in COPD patients. Chest 2004;126(4):1123-33.
Magnussen 2008 {published data only}
  • Boehringer Ingelheim. A trial evaluating the efficacy and safety of inhaled tiotropium 18 µg qd in patients with COPD and a concomitant diagnosis of asthma. www.clinicaltrials.gov (accessed 6 March 2014).
  • Magnussen H. A 12-week randomised, double blind, placebo-controlled, parallel group trial evaluating the efficacy and safety of inhaled tiotropium 18 μg q.d. in patients with COPD and a concomitant diagnosis of asthma. www.trials.boehringer-ingelheim.com (accessed 6 March 2014). [trial number: 205.301]
  • Magnussen H, Bugnas B, Van Noord J, Schmidt P, Gerken F, Kesten S. Improvements with tiotropium in COPD patients with concomitant asthma. Respiratory Medicine 2008;102(1):50-6. [CTG: NCT00152984]
  • Magnussen H, Bugnas B, Van Noord J, Schmidt P, Gerken F, Kesten S, et al. Spirometric improvements with tiotropium in COPD patients with concomitant asthma [Abstract]. American Thoracic Society International Conference; May 18-23; San Francisco. 2007:Poster #A5.
Mahler 1999 {published data only}
  • Ferguson G, Funck-Brentano C, Fischer T, Darken P, Troy S, Compton C, et al. Cardiovascular safety of salmeterol in patients with COPD. American Journal of Respiratory and Critical Care Medicine 2002;165(Suppl 8):A228.
  • Ferguson GT, Funck-Brentano C, Fischer T, Darken P, Reisner C. Cardiovascular safety of salmeterol in COPD. Chest 2003;123(6):1817-24.
  • GlaxoSmithKline. A randomized, double-blind, double-dummy, comparative clinical trial of 12-week courses of salmeterol xinafoate versus ipratropium bromide versus placebo (PRN Ventolin) in subjects with chronic obstructive pulmonary disease. www.gsk-clinicalstudyregister.com (accessed 20 December 2012). [GSK: SLGA4005]
  • Mahler DA, Donohue JF, Barbee RA, Goldman MD, Gross NJ, Wisniewski ME, et al. Efficacy of salmeterol xinafoate in the treatment of COPD. Chest 1999;115(4):957-65.
Mahler 2010 {published data only}
  • Mahler DA, D'Urzo A, Peckitt C, Lassen C, Kramer B, Filcek S. Combining once-daily bronchodilators In COPD: indacaterol plus tiotropium versus tiotropium alone. American Journal of Respiratory and Critical Care Medicine 2011;183:A1591.
  • Novartis. A randomized, double-blind, controlled, parallel group, 12-week treatment study to compare the efficacy and safety of the combination of indacaterol 150 μg once daily with open label tiotropium 18 μg once daily versus open label tiotropium 18 μg once daily in patients with moderate-to-severe chronic obstructive pulmonary disease. www.novctrd.com (accessed 6 March 2014). [: CQAB149B2341]
Mahler 2010a {published data only}
  • Mahler DA, D'Urzo A, Peckitt C, Lassen C, Kramer B, Filcek S. Combining once-daily bronchodilators In COPD: indacaterol plus tiotropium versus tiotropium alone. American Journal of Respiratory and Critical Care Medicine 2011;183:A1591.
  • Novartis. A randomized, double-blind, controlled, parallel group, 12-week treatment study to compare the efficacy and safety of the combination of indacaterol 150 μg once daily with open label tiotropium 18 μg once daily versus open label tiotropium 18 μg once daily in patients with moderate-to-severe chronic obstructive pulmonary disease. www.novctrd.com (accessed 6 March 2014). [: CQAB149B2351]
Martinez 2013 {published data only}
  • Martinez FJ, Boscia J, Feldman G, Scott-Wilson C, Kilbride S, Fabbri L, et al. Fluticasone furoate/vilanterol (100/25; 200/25 mug) improves lung function in COPD: a randomised trial. Respiratory Medicine 2013;107(4):550-9.
Mirici 2001 {published data only}
  • Mirici A, Bektas Y, Ozbakis G, Erman Z. Effect of inhaled corticosteroids on respiratory function tests and airway inflammation in stable chronic obstructive pulmonary disease. Clinical Drug Investigation 2001;21(12):835-42.
Moita 2008 {published data only}
  • Boehringer Ingelheim. Spiriva® assessment of FEV1—(SAFE-Portugal). The effect of inhaled tiotropium bromide (18 mcg once daily) on the change in FEV1 during treatment in patients with COPD. A three-month parallel group, double-blind, randomised, placebo-controlled study. www.trials.boehringer-ingelheim.com (accessed 6 March 2014). [trial number: 205.282]
  • Moita J, Barbara C, Cardoso J, Costa R, Sousa M, Ruiz J, et al. Tiotropium improves FEV1 in patients with COPD irrespective of smoking status. Pulmonary Pharmacology and Therapeutics 2008;21(1):146-51. [CTG: NCT00239408]
  • Moita J, Costa R, Barbara C, Cardosa J, Rulz J, Sousa M. The effect of tiotropium bromide in a stable cohort of COPD patients in Portugal [Abstract]. European Respiratory Journal 2005;26(Suppl 49):Abstract No. 1955.
NCT00144326 {published data only}
  • García Río, F. A randomised, double-blind, placebo-controlled, 12 week trial to evaluate the effect of tiotropium inhalation capsules on the magnitude of exercise, measured using an accelerometer, in patients with chronic obstructive pulmonary disease (COPD). www.trials.boehringer-ingelheim.com (accessed 15 October 2007). [CTG: NCT00144326; trial number: 205.269]
Nelson 2007 {published data only}
  • Gross NJ, Lapidus R, Dunn LJ, Lynn LD, Denis-Mize K, Rinehart M. Nebulized formoterol is an effective bronchodilator and improves the quality of life for COPD patients [Abstract]. American Thoracic Society International Conference; May 18-23; San Francisco. 2007:Poster A10.
  • Gross NJ, Nelson HS, Lapidus RJ, Dunn L, Lynn L, Rinehart M, et al. Efficacy and safety of formoterol fumarate delivered by nebulization to COPD patients. Respiratory Medicine 2008;102(2):189-97.
  • Nelson HS, Gross NJ, Levine B, Kerwin EM, Rinehart M, Denis-Mize K, et al. Cardiac safety profile of nebulized formoterol in adults with COPD: a 12-week, multicenter, randomized, double-blind, double-dummy, placebo- and active-controlled trial. Clinical Therapeutics 2007;29(10):2167-78.
  • Nelson HS, Gross NJ, Rinehart M, Denis-Mize K. Cardiovascular safety of nebulized formoterol in COPD patients: a double-blind, placebo-controlled study. Chest 2007;132(4):529b-530.
  • Nelson HS, ZuWallack R, Levine B, Kerwin EM, Denis-Mize K, Rinehart M. Safety profile of formoterol fumarate delivered by nebulization to COPD patients [Abstract]. American Thoracic Society International Conference; May 18-23; San Francisco. 2007:Poster A11.
Nishimura 1999 {published data only}
O'Donnell 2006 {published data only}
  • Celli B, Emmett A, Crater G, Kalberg C. Salmeterol/fluticasone propionate (SFC) improves the inspiratory to total lung capacity ratio (IC/TLC) and exercise endurance time in patients with COPD. European Respiratory Journal 2006;28(Suppl 50):764s.
  • GlaxoSmithKline. A randomized, double-blind, placebo-controlled, parallel group clinical trial evaluating the effect of the fluticasone propionate/salmeterol combination product 250/50mcg bid via DISKUS and salmeterol 50mcg bid via DISKUS on lung hyperinflation in subjects with chronic obstructive pulmonary disease (COPD). http://www.gsk-clinicalstudyregister.com/ (accessed 10 June 2013). [GSK: SCO40030]
  • Make B, Emmett A, Crater G, O'Dell D, Kalberg C. Improvement in exercise endurance time (EET) with fluticasone propionate/salmeterol correlations with spirometry and plethysmography. American Thoracic Society International Conference; May 19-21; San Diego. 2006.
  • O'Donnell DE, Sciurba F, Celli B, Mahler DA, Webb KA, Kalberg CJ, et al. Effect of fluticasone propionate/salmeterol on lung hyperinflation and exercise endurance in COPD. Chest 2006;130(3):647-56.
Rennard 2001 {published data only}
  • Ferguson G, Funck-Brentano C, Fischer T, Darken P, Troy S, Compton C, et al. Cardiovascular safety of salmeterol in patients with COPD. American Journal of Respiratory and Critical Care Medicine 2002;165(Suppl 8):A228.
  • Ferguson GT, Funck-Brentano C, Fischer T, Darken P, Reisner C. Cardiovascular safety of salmeterol in COPD. Chest 2003;123(6):1817-24.
  • GlaxoSmithKline. A randomized, double-blind, double-dummy, comparative clinical trial of 12-week courses of salmeterol xinafoate versus ipratropium bromide versus placebo (PRN Ventolin®) in subjects with chronic obstructive pulmonary disease. www.gsk-clinicalstudyregister.com (accessed 7 December 2012). [GSK: SLGA4004]
  • Rennard SI, Anderson W, ZuWallack R, Broughton J, Bailey W, Friedman M, et al. Use of a long-acting inhaled beta2-adrenergic agonist, salmeterol xinafoate, in patients with chronic obstructive pulmonary disease. American Journal of Respiratory and Critical Care Medicine 2001;163(5):1087-92.
Robertson 1986 {published data only}
  • Robertson AS, Gove RI, Wieland GA, Burge PS. A double-blind comparison of oral prednisolone 40 mg/day with inhaled beclomethasone dipropionate 1500 ug/day in patients with adult onset chronic obstructive airways disease. European Journal of Respiratory Diseases 1986;146(Suppl):565-9.
Rutgers 1998 {published data only}
  • Rutgers SR, Koeter GH, van der Mark TW, Postma DS. Short-term treatment with budesonide does not improve hyperresponsiveness to adenosine 5'-monophosphate in COPD. American Journal of Respiratory and Critical Care Medicine 1998;157(3 Pt 1):880-6.
SCO40034 {published data only}
  • GlaxoSmithKline. A multicentre, randomised, double-blind, double dummy, parallel group 12-week exploratory study to compare the effect of the fluticasone/salmeterol propionate combination product (SERETIDE™) 50/500mcg bd via the DISKUS™/ACCUHALER™ inhaler with tiotropium bromide 18 mcg od via the Handihaler inhalation device on efficacy and safety in patients with chronic obstructive pulmonary disease (COPD). www.gsk-clinicalstudyregister.com/files/pdf/23678.pdf (accessed 16 June 2009). [GSK: SCO40034]
Sin 2004 {published data only}
  • Sin DD, Lacy P, York E, Man SFP. Effects of fluticasone on systemic markers of inflammation in chronic obstructive pulmonary disease. American Journal of Respiratory and Critical Care Medicine 2004;170(7):760-5.
Sin 2008 {published data only}
  • Sin DD, Man SF, Marciniuk DD, Ford G, FitzGerald M, Wong E, et al. ABC (Advair, Biomarkers in COPD) Investigators. The effects of fluticasone with or without salmeterol on systemic biomarkers of inflammation in chronic obstructive pulmonary disease. American Journal of Respiratory and Critical Care Medicine 2008;177(11):1207-14.
Sun 2007 {published data only}
  • Sun LH, Tan Y, Qiao Y, Fang SR, Xie H. Evaluation of clinical effect and safety of tiotropium bromide in treating stable chronic obstructive pulmonary disease. Zhongguo Xinyao yu Linchuang Zazhi 2007;26(5):328-31.
  • Yan L, Lu YK. Effect of domestic tiotropium bromide inhalation in patients with COPD at stable stage. Chinese Journal of New Drugs 2010;19(2):127-9, 138.
Tashkin 2009 {published data only}
  • Tashkin D, Varghese S. Formoterol treatment plus tiotropium results in greater improvements in lung function compared with tiotropium administered alone in patients with COPD [Abstract]. Journal of Allergy and Clinical Immunology 2007;119(1 Suppl):S4 [13].
  • Tashkin D, Varghese S. The therapeutic effect of treatment with formoterol plus tiotropium was greater than the effect of treatment with tiotropium alone in COPD: findings from a 12-week, multicenter, double-blind, placebo-controlled trial. Chest 2007;132(4):529a.
  • Tashkin DP. Formoterol and tiotropium reduces rescue medication use more than tiotropium alone in patients with moderate COPD: findings from a 12 week randomized placebo controlled trial [Abstract]. American Thoracic Society International Conference; May 16-21; Toronto. 2008:A647[#F5].
  • Tashkin DP, Pearle J, Iezzoni D, Varghese ST. Formoterol and tiotropium compared with tiotropium alone for treatment of COPD. Journal of Chronic Obstructive Pulmonary Disease 2009;6(1):17-25.
  • Tashkin DP, Pearle JL, Varghese S. Improvement of lung function with coadministered formoterol and tiotropium, regardless of smoking status in patients with chronic obstructive pulmonary disease [Abstract]. Chest 2008;134(4):103002s.
Thompson 1992 {published data only}
  • Thompson AB, Mueller MB, Heires AJ, Bohling TL, Daughton D, Yancey SW, et al. Aerosolized beclomethasone in chronic bronchitis: improved pulmonary function and diminished airway inflammation. American Review of Respiratory Disease 1992;146(2):389-95. [MEDLINE: 93143171]
Thompson 2002 {published data only}
van der Valk 2002 {published data only}
  • van der Valk P, Monninkhof E, van der Palen J, Zielhuis G, van Herwaarden C, van der Phalen J. Effect of discontinuation of inhaled corticosteroids in patients with chronic obstructive pulmonary disease: the COPE study. American Journal of Respiratory and Critical Care Medicine 2002;166(10):1358-63.
van Grunsven 2003 {published data only}
  • van Grunsven P, Schermer T, Akkermans R, Albers M, van den Boom G, van Schayck O, et al. Short- and long-term efficacy of fluticasone propionate in subjects with early signs and symptoms of chronic obstructive pulmonary disease. Results of the DIMCA study. Respiratory Medicine 2003;97(12):1303-12.
Verkinde 2006 {published data only}
  • Huchon G. Effect of a 12-week treatment with inhaled tiotropium (18 mcg once daily) on lung function and static lung volumes in stable, moderate to severe COPD patients. Correlation to dyspnoea scales: a double-blind, placebo-controlled, randomized, parallel group study. www.trials.boehringer-ingelheim.com (accessed 6 March 2014). [trial number: 205.215]
  • Huchon G, Verkindre C, Bart F, Aguilaniu B, Guerin JC, Lemerre C, et al. Improvements with tiotropium on endurance measure by the shuttle walking test (SWT) and on health related quality of life (HRQoL) in COPD patients. European Respiratory Society 12th Annual Congress; Sep 14-18; Stockholm. 2002.
  • Verkindre C, Bart F, Aguilaniu B, Fortin F, Guerin JC, Le Merre C, et al. The effect of tiotropium on hyperinflation and exercise capacity in chronic obstructive pulmonary disease. Respiration 2006;73(4):420-7.
Voshaar 2008 {published data only}
  • Boehringer Ingelheim. A randomised, double-blind, double-dummy, placebo- and active-controlled, parallel group efficacy and safety comparison of 12-week treatment of two doses [5 mcg (2 actuations of 2.5 mcg) and 10 mcg (2 actuations of 5 mcg)] of tiotropium inhalation solution delivered by the Respimat inhaler, placebo and ipratropium bromide inhalation aerosol (MDI) in patients with chronic obstructive pulmonary disease (COPD). www.trials.boehringer-ingelheim.com (accessed 6 March 2014). [trial number: 205.251]
  • Boehringer Ingelheim. A randomized, double-blind, double-dummy, placebo- and active-controlled, parallel group efficacy and safety comparison of 12-week treatment of two doses (5 Mcg and 10 Mcg) of tiotropium inhalation solution delivered by the Respimat inhaler, placebo and ipratropium bromide inhalation aerosol (MDI) in patients with chronic obstructive pulmonary disease (COPD). www.clinicaltrials.gov (accessed 6 March 2014). [trial number: 205.252]
  • Voshaar T, Lapidus R, Maleki-Yazdi R, Timmer W, Rubin E, Lowe L, et al. A randomised study of tiotropium Respimat soft mist inhaler versus ipratropium PMDI in chronic obstructive pulmonary disease [Abstract]. Thorax 2006;61(Suppl 2):ii40 [S112].
  • Voshaar T, Lapidus R, Maleki-Yazdi R, Timmer W, Rubin E, Lowe L, et al. A randomized study of tiotropium Respimat Soft Mist inhaler vs. ipratropium pMDI in COPD. Respiratory Medicine 2008;102(1):32-41. [CTG: NCT00239473; CTG: NCT00240435]
Wadbo 2002 {published data only}
  • Wadbo M, Lofdahl CG, Larsson K, Skoogh BE, Tornling G, Arwestrom E, et al. Effects of formoterol and ipratropium bromide in COPD: a 3-month placebo-controlled study. European Respiratory Journal 2002;20(5):1138-46. [: 0903-1936]
Watkins 2002 {published data only}
  • Watkins M, Wire P, Yates J, Fischer T, Chang C, Horstman D, et al. Sustained FEV increases in COPD patients induced by salmeterol 50 mcg twice daily via the diskus inhaler. American Journal of Respiratory and Critical Care Medicine 2002;165(Suppl 8):A228.
Weiner 1995 {published data only}
Weiner 1999 {published data only}
Weir 1990 {published data only}
  • Weir DC, Gove RI, Robertson AS, Burge PS. Corticosteroid trials in non-asthmatic chronic airflow obstruction: a comparison of oral prednisolone and inhaled beclomethasone dipropionate. Thorax 1990;45(2):112-7. [MEDLINE: 90194025]
  • Weir DC, Gove RI, Robertson AS, Burge PS. Response to corticosteroids in chronic airflow obstruction: relationship to emphysema and airways collapse. European Respiratory Journal 1991;4(10):1185-90.
  • Weir DC, Robertson AS, Gove RI, Burge PS. Time course of response to oral and inhaled corticosteroids in non-asthmatic chronic airflow obstruction. Thorax 1990;45(2):118-21.
Weir 1999 {published data only}
  • Weir DC, Bale GA, Bright P, Sherwood Burge P. A double-blind placebo-controlled study of the effect of inhaled beclomethasone dipropionate for 2 years in patients with nonasthmatic chronic obstructive pulmonary disease. Clinical and Experimental Allergy Supplement 1999;29(2):125-8.
Welte 2009 {published data only}
  • Welte T, Hartman L, Polanowski T, Hernandez P. Budesonide/formoterol added to tiotropium is well tolerated and reduces risk of severe exacerbations in COPD patients [Abstract]. American Thoracic Society International Conference; May 15-20 San Diego. 2009:A6188 [Poster #215].
  • Welte T, Miravitlles M, Hernandez P, Eriksson G, Peterson S, Polanowski T, et al. Addition of budesonide/formoterol to tiotropium reduces the number of exacerbation days compared with tiotropium alone. Chest 2009;136(4):26S-f.
  • Welte T, Miravitlles M, Hernandez P, Eriksson G, Peterson S, Polanowski T, et al. Budesonide/formoterol added to tiotropium provides rapid improvements in lung function and ability to undertake morning activities. Chest 2009;136(4):24S-g.
  • Welte T, Miravitlles M, Hernandez P, Eriksson G, Peterson S, Polanowski T, et al. Efficacy and tolerability of budesonide/formoterol added to tiotropium in patients with chronic obstructive pulmonary disease. American Journal of Respiratory and Critical Care Medicine 2009;180(8):741-50.
  • Welte T, Miravitlles M, Hernandez P, Hartman L, Polanowski T, Kessler R. Budesonide/formoterol added to tiotropium improves lung function, health status, symptoms & morning activities in COPD patients [Abstract]. European Respiratory Society 19th Annual Congress; Sep 12-15; Vienna. 2009:[P2005].
  • Welte T, Miravitlles M, Hernandez P, Peterson S, Polanowski T, Kessler R. Budesonide/formoterol added to tiotropium improves exacerbations and exacerbation-related antibiotic use in patients with COPD [Abstract]. European Respiratory Society 19th Annual Congress; Sep 12-15; Vienna. 2009:[P2012].
  • Welte T, Miravitlles M, Peterson S, Polanowski T, Kessler R. Budesonide/formoterol added to tiotropium improves the management of COPD patients [Abstract]. European Respiratory Society 19th Annual Congress; Sep 12-15; Vienna. 2009:A6192 [Poster #216].
Wempe 1992 {published data only}
Wouters 2005 {published data only}
  • Rizzato G. COPD: immediate and sustained deterioration after withdrawal of fluticasone in patients under therapy with salmeterol + fluticasone. [Italian]. Internista 2005;13(4):225-30.
  • Wouters EF, Postma DS, Fokkens B, Hop WC, Prins J, Kuipers AF, et al. Withdrawal of fluticasone propionate from combined salmeterol/fluticasone treatment in patients with COPD causes immediate and sustained disease deterioration: a randomised controlled trial. Thorax 2005;60(6):480-7.
Yang 2012 {published data only}
  • Yang W, Liu J, Gao B, Cheng K. Effect of fluticasone propionate/salmeterol on exercise endurance in moderate-severe COPD [Abstract]. European Respiratory Society 22nd Annual Congress; Sep 1-5; Vienna. 2012; Vol. 40:624s [P3459].
Yildiz 2004 {published data only}

References to ongoing studies

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to ongoing studies
  4. Additional references
INSTEAD {unpublished data only}
  • Comparison of Indacaterol 150 μg Once Daily (o.d.) With Salmeterol/Fluticasone Propionate 50 μg/500 μg Twice Daily (b.i.d.) (INSTEAD). clinicaltrials.gov (accessed 5 December 2013).
Vestbo 2013 {published data only}
  • Vestbo J, Anderson J, Brook RD, Calverley PMA, Celli BR, Crim C, et al. The study to understand mortality and morbidity in COPD (SUMMIT) study protocol. European Respiratory Journal 2013;41(5):1017-22.

Additional references

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to ongoing studies
  4. Additional references
Appleton 2006
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ATS/ERS 2004
Barr 2005
Beeh 2010
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Berger 2008
Cazzola 2008
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Chong 2012
Chuck 2008
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Cipriani 2013
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Cooper 2009
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Cope 2012
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Cope 2013
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Decramer 2013
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Dias 2010
Dias 2013
Dias 2013a
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Dong 2013
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Earnshaw 2007
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Effing 2007
Fattore 2005
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Geake 2012
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GOLD
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Higgins 2011
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Higgins 2012
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Hutchinson 2010
Karner 2011
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Karner 2011a
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Karner 2012
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Karner 2012a
Kew 2013
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Kew 2014
Lacasse 2006
Loke 2011
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Lu 2006
Moen 2010
Nannini 2012
Nannini 2013
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Nannini 2013a
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NICE 2011
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Puhan 2009
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Puhan 2011
Rodrigo 2008
Rodrigo 2009
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Sestini 2009
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Singh 2010
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Spencer 2011
Spiegelhalter 2002
Tashkin 2008
van der Meer 2001
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Welsh 2013
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Yang 2012a