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Combined corticosteroid and long-acting beta2-agonist in one inhaler versus placebo for chronic obstructive pulmonary disease

  1. Luis Javier Nannini1,*,
  2. Phillippa Poole2,
  3. Stephen J Milan3,
  4. Rebecca Holmes3,
  5. Rebecca Normansell3

Editorial Group: Cochrane Airways Group

Published Online: 10 NOV 2013

Assessed as up-to-date: 26 JUN 2013

DOI: 10.1002/14651858.CD003794.pub4


How to Cite

Nannini LJ, Poole P, Milan SJ, Holmes R, Normansell R. Combined corticosteroid and long-acting beta2-agonist in one inhaler versus placebo for chronic obstructive pulmonary disease. Cochrane Database of Systematic Reviews 2013, Issue 11. Art. No.: CD003794. DOI: 10.1002/14651858.CD003794.pub4.

Author Information

  1. 1

    Hospital E Peron, Pulmonary Section, G. Baigorria, Santa Fe - Rosario, Argentina

  2. 2

    University of Auckland, Department of Medicine, Auckland, New Zealand

  3. 3

    St George's, University of London, Population Health Sciences and Education, London, UK

*Luis Javier Nannini, Pulmonary Section, Hospital E Peron, Ruta 11 Y Jm Estrada, G. Baigorria, Santa Fe - Rosario, 2152, Argentina. nanninilj@circulomedicorosario.org.

Publication History

  1. Publication Status: New search for studies and content updated (conclusions changed)
  2. Published Online: 10 NOV 2013

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[Figure 1]
Figure 1. Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
[Figure 2]
Figure 2. Forest plot of comparison: 1 Combined inhalers versus placebo (primary outcomes), outcome: 1.1 Exacerbation rates with combined inhalers versus placebo.
[Figure 3]
Figure 3. Forest plot of comparison: 1 Combined inhalers versus placebo (primary outcomes), outcome: 1.2 Mortality.
[Figure 4]
Figure 4. Forest plot of comparison: 1 Combined inhalers versus placebo (primary outcomes), outcome: 1.3 Pneumonia.
[Figure 5]
Figure 5. Forest plot of comparison: 1 Combined inhalers versus placebo (primary outcomes), outcome: 1.4 Hospitalisations due to COPD exacerbations.
[Figure 6]
Figure 6. Funnel plot of comparison: 1 Combined inhalers versus placebo (primary outcomes), outcome: 1.2 Mortality.
[Analysis 1.1]
Analysis 1.1. Comparison 1 Combined inhalers versus placebo (primary outcomes), Outcome 1 Exacerbation rates with combined inhalers versus placebo.
[Analysis 1.2]
Analysis 1.2. Comparison 1 Combined inhalers versus placebo (primary outcomes), Outcome 2 Mortality.
[Analysis 1.3]
Analysis 1.3. Comparison 1 Combined inhalers versus placebo (primary outcomes), Outcome 3 Pneumonia.
[Analysis 1.4]
Analysis 1.4. Comparison 1 Combined inhalers versus placebo (primary outcomes), Outcome 4 Hospitalisations due to COPD exacerbations.
[Analysis 1.5]
Analysis 1.5. Comparison 1 Combined inhalers versus placebo (primary outcomes), Outcome 5 Number of participants with at least one exacerbation.
[Analysis 2.1]
Analysis 2.1. Comparison 2 Fluticasone/salmeterol (FPS) versus placebo (PLA), Outcome 1 Exacerbations.
[Analysis 2.2]
Analysis 2.2. Comparison 2 Fluticasone/salmeterol (FPS) versus placebo (PLA), Outcome 2 Number of participants with at least one exacerbation.
[Analysis 2.3]
Analysis 2.3. Comparison 2 Fluticasone/salmeterol (FPS) versus placebo (PLA), Outcome 3 Participants with at least one exacerbation by type.
[Analysis 2.4]
Analysis 2.4. Comparison 2 Fluticasone/salmeterol (FPS) versus placebo (PLA), Outcome 4 Exacerbations by type.
[Analysis 2.5]
Analysis 2.5. Comparison 2 Fluticasone/salmeterol (FPS) versus placebo (PLA), Outcome 5 Mortality.
[Analysis 2.6]
Analysis 2.6. Comparison 2 Fluticasone/salmeterol (FPS) versus placebo (PLA), Outcome 6 Change from baseline in St George's Respiratory Questionnaire (total score).
[Analysis 2.7]
Analysis 2.7. Comparison 2 Fluticasone/salmeterol (FPS) versus placebo (PLA), Outcome 7 Change from baseline in Chronic Respiratory Disease Questionnaire scores.
[Analysis 2.8]
Analysis 2.8. Comparison 2 Fluticasone/salmeterol (FPS) versus placebo (PLA), Outcome 8 Change from baseline in Transitional Dyspnoea Index (TDI) scores.
[Analysis 2.9]
Analysis 2.9. Comparison 2 Fluticasone/salmeterol (FPS) versus placebo (PLA), Outcome 9 Change from baseline in predose FEV1.
[Analysis 2.10]
Analysis 2.10. Comparison 2 Fluticasone/salmeterol (FPS) versus placebo (PLA), Outcome 10 Change from baseline in postdose FEV1.
[Analysis 2.11]
Analysis 2.11. Comparison 2 Fluticasone/salmeterol (FPS) versus placebo (PLA), Outcome 11 Change from baseline in rescue medication usage (puffs/d).
[Analysis 2.12]
Analysis 2.12. Comparison 2 Fluticasone/salmeterol (FPS) versus placebo (PLA), Outcome 12 Withdrawals—total.
[Analysis 2.13]
Analysis 2.13. Comparison 2 Fluticasone/salmeterol (FPS) versus placebo (PLA), Outcome 13 Withdrawals due to adverse events.
[Analysis 2.14]
Analysis 2.14. Comparison 2 Fluticasone/salmeterol (FPS) versus placebo (PLA), Outcome 14 Withdrawals due to lack of efficacy.
[Analysis 2.15]
Analysis 2.15. Comparison 2 Fluticasone/salmeterol (FPS) versus placebo (PLA), Outcome 15 Adverse events—any.
[Analysis 2.16]
Analysis 2.16. Comparison 2 Fluticasone/salmeterol (FPS) versus placebo (PLA), Outcome 16 Adverse events—'serious'.
[Analysis 2.17]
Analysis 2.17. Comparison 2 Fluticasone/salmeterol (FPS) versus placebo (PLA), Outcome 17 Adverse events—pneumonia.
[Analysis 2.18]
Analysis 2.18. Comparison 2 Fluticasone/salmeterol (FPS) versus placebo (PLA), Outcome 18 Adverse events—candidiasis.
[Analysis 2.19]
Analysis 2.19. Comparison 2 Fluticasone/salmeterol (FPS) versus placebo (PLA), Outcome 19 Adverse events—hoarseness.
[Analysis 2.20]
Analysis 2.20. Comparison 2 Fluticasone/salmeterol (FPS) versus placebo (PLA), Outcome 20 Adverse events—palpitations.
[Analysis 2.21]
Analysis 2.21. Comparison 2 Fluticasone/salmeterol (FPS) versus placebo (PLA), Outcome 21 Adverse events—blood glucose increased.
[Analysis 2.22]
Analysis 2.22. Comparison 2 Fluticasone/salmeterol (FPS) versus placebo (PLA), Outcome 22 Adverse event—skin bruising.
[Analysis 2.23]
Analysis 2.23. Comparison 2 Fluticasone/salmeterol (FPS) versus placebo (PLA), Outcome 23 Adverse events—bronchitis.
[Analysis 2.24]
Analysis 2.24. Comparison 2 Fluticasone/salmeterol (FPS) versus placebo (PLA), Outcome 24 Adverse events—upper respiratory tract infection.
[Analysis 2.25]
Analysis 2.25. Comparison 2 Fluticasone/salmeterol (FPS) versus placebo (PLA), Outcome 25 Adverse events—nasopharyngitis.
[Analysis 2.26]
Analysis 2.26. Comparison 2 Fluticasone/salmeterol (FPS) versus placebo (PLA), Outcome 26 Adverse events—cough.
[Analysis 2.27]
Analysis 2.27. Comparison 2 Fluticasone/salmeterol (FPS) versus placebo (PLA), Outcome 27 Adverse events—headache.
[Analysis 3.1]
Analysis 3.1. Comparison 3 Budesonide/formoterol (BDF) versus placebo (PLA), Outcome 1 Severe exacerbations.
[Analysis 3.2]
Analysis 3.2. Comparison 3 Budesonide/formoterol (BDF) versus placebo (PLA), Outcome 2 Mean severe exacerbation rates per participant per year.
[Analysis 3.3]
Analysis 3.3. Comparison 3 Budesonide/formoterol (BDF) versus placebo (PLA), Outcome 3 Mortality.
[Analysis 3.4]
Analysis 3.4. Comparison 3 Budesonide/formoterol (BDF) versus placebo (PLA), Outcome 4 Change from baseline in St George's Respiratory Questionnaire (total score).
[Analysis 3.5]
Analysis 3.5. Comparison 3 Budesonide/formoterol (BDF) versus placebo (PLA), Outcome 5 Quality of life—change scores.
[Analysis 3.6]
Analysis 3.6. Comparison 3 Budesonide/formoterol (BDF) versus placebo (PLA), Outcome 6 Symptoms (change scores).
[Analysis 3.7]
Analysis 3.7. Comparison 3 Budesonide/formoterol (BDF) versus placebo (PLA), Outcome 7 Breathlessness, cough and sputum score (BCSS) change from baseline—average over treatment period.
[Analysis 3.8]
Analysis 3.8. Comparison 3 Budesonide/formoterol (BDF) versus placebo (PLA), Outcome 8 Rescue medication usage.
[Analysis 3.9]
Analysis 3.9. Comparison 3 Budesonide/formoterol (BDF) versus placebo (PLA), Outcome 9 Mean FEV1 (% change from baseline).
[Analysis 3.10]
Analysis 3.10. Comparison 3 Budesonide/formoterol (BDF) versus placebo (PLA), Outcome 10 Average 12-hour FEV1 change from baseline—end of treatment (L).
[Analysis 3.11]
Analysis 3.11. Comparison 3 Budesonide/formoterol (BDF) versus placebo (PLA), Outcome 11 Predose FEV1 [L] change from baseline to the average over the randomised treatment period.
[Analysis 3.12]
Analysis 3.12. Comparison 3 Budesonide/formoterol (BDF) versus placebo (PLA), Outcome 12 1 Hour postdose FEV1 [L] change from baseline to the average over the randomised treatment period.
[Analysis 3.13]
Analysis 3.13. Comparison 3 Budesonide/formoterol (BDF) versus placebo (PLA), Outcome 13 FEV1 at 12-hour change from baseline—end of treatment (L).
[Analysis 3.14]
Analysis 3.14. Comparison 3 Budesonide/formoterol (BDF) versus placebo (PLA), Outcome 14 Morning PEFR change from baseline, average over treatment period (L/min).
[Analysis 3.15]
Analysis 3.15. Comparison 3 Budesonide/formoterol (BDF) versus placebo (PLA), Outcome 15 Evening PEFR mean change from baseline, average over treatment period (L/min).
[Analysis 3.16]
Analysis 3.16. Comparison 3 Budesonide/formoterol (BDF) versus placebo (PLA), Outcome 16 Withdrawals—total.
[Analysis 3.17]
Analysis 3.17. Comparison 3 Budesonide/formoterol (BDF) versus placebo (PLA), Outcome 17 Withdrawals due to adverse events.
[Analysis 3.18]
Analysis 3.18. Comparison 3 Budesonide/formoterol (BDF) versus placebo (PLA), Outcome 18 Withdrawals due to lack of efficacy.
[Analysis 3.19]
Analysis 3.19. Comparison 3 Budesonide/formoterol (BDF) versus placebo (PLA), Outcome 19 Adverse event—any.
[Analysis 3.20]
Analysis 3.20. Comparison 3 Budesonide/formoterol (BDF) versus placebo (PLA), Outcome 20 Adverse events—'serious'.
[Analysis 3.21]
Analysis 3.21. Comparison 3 Budesonide/formoterol (BDF) versus placebo (PLA), Outcome 21 Adverse events—pneumonia.
[Analysis 3.22]
Analysis 3.22. Comparison 3 Budesonide/formoterol (BDF) versus placebo (PLA), Outcome 22 Adverse events—candidiasis.
[Analysis 3.23]
Analysis 3.23. Comparison 3 Budesonide/formoterol (BDF) versus placebo (PLA), Outcome 23 Adverse events—dysphonia.
[Analysis 3.24]
Analysis 3.24. Comparison 3 Budesonide/formoterol (BDF) versus placebo (PLA), Outcome 24 Adverse events—cataracts.
[Analysis 3.25]
Analysis 3.25. Comparison 3 Budesonide/formoterol (BDF) versus placebo (PLA), Outcome 25 Adverse events—COPD.
[Analysis 3.26]
Analysis 3.26. Comparison 3 Budesonide/formoterol (BDF) versus placebo (PLA), Outcome 26 Adverse events—tremor.
[Analysis 3.27]
Analysis 3.27. Comparison 3 Budesonide/formoterol (BDF) versus placebo (PLA), Outcome 27 Adverse events—palpitations.
[Analysis 3.28]
Analysis 3.28. Comparison 3 Budesonide/formoterol (BDF) versus placebo (PLA), Outcome 28 Adverse events—lumbar spine bone density change from baseline (g/cm2).
[Analysis 3.29]
Analysis 3.29. Comparison 3 Budesonide/formoterol (BDF) versus placebo (PLA), Outcome 29 Adverse events—hip bone density change from baseline (g/cm2).
[Analysis 4.1]
Analysis 4.1. Comparison 4 Mometasone/formoterol (MF/F) versus placebo, Outcome 1 Number of participants with at least one exacerbation.
[Analysis 4.2]
Analysis 4.2. Comparison 4 Mometasone/formoterol (MF/F) versus placebo, Outcome 2 Number of participants having at least one moderate or severe exacerbation.
[Analysis 4.3]
Analysis 4.3. Comparison 4 Mometasone/formoterol (MF/F) versus placebo, Outcome 3 Mortality.
[Analysis 4.4]
Analysis 4.4. Comparison 4 Mometasone/formoterol (MF/F) versus placebo, Outcome 4 Change from baseline in St George's Respiratory Questionnaire (total score).
[Analysis 4.5]
Analysis 4.5. Comparison 4 Mometasone/formoterol (MF/F) versus placebo, Outcome 5 Change from baseline in FEV1 AUC0–12 hours (mL)—week 13.
[Analysis 4.6]
Analysis 4.6. Comparison 4 Mometasone/formoterol (MF/F) versus placebo, Outcome 6 Mean change from baseline AM predose FEV1 at 13 weeks (mL).
[Analysis 4.7]
Analysis 4.7. Comparison 4 Mometasone/formoterol (MF/F) versus placebo, Outcome 7 Withdrawals—total.
[Analysis 4.8]
Analysis 4.8. Comparison 4 Mometasone/formoterol (MF/F) versus placebo, Outcome 8 Withdrawals due to lack of efficacy.
[Analysis 4.9]
Analysis 4.9. Comparison 4 Mometasone/formoterol (MF/F) versus placebo, Outcome 9 Withdrawals due to adverse events.
[Analysis 4.10]
Analysis 4.10. Comparison 4 Mometasone/formoterol (MF/F) versus placebo, Outcome 10 Adverse events—any.
[Analysis 4.11]
Analysis 4.11. Comparison 4 Mometasone/formoterol (MF/F) versus placebo, Outcome 11 Adverse events—serious.
[Analysis 4.12]
Analysis 4.12. Comparison 4 Mometasone/formoterol (MF/F) versus placebo, Outcome 12 Adverse events—pneumonia.
[Analysis 4.13]
Analysis 4.13. Comparison 4 Mometasone/formoterol (MF/F) versus placebo, Outcome 13 Adverse events—candidiasis.
[Analysis 4.14]
Analysis 4.14. Comparison 4 Mometasone/formoterol (MF/F) versus placebo, Outcome 14 Adverse events—dysphonia.
[Analysis 4.15]
Analysis 4.15. Comparison 4 Mometasone/formoterol (MF/F) versus placebo, Outcome 15 Adverse events—cataract.
[Analysis 4.16]
Analysis 4.16. Comparison 4 Mometasone/formoterol (MF/F) versus placebo, Outcome 16 Adverse events—COPD requiring hospitalisation.