Conflict of interest statement: MK, SHL and L-WH declare that they have no conflicting interests with respect to this study. MI has previously served as a member of the scientific advisory board for GlaxoSmithKline KK, Nippon Boehringer Ingelheim, Novartis Pharma KK, and Astrazeneca KK. He has received lecture fees from GlaxoSmithKline KK, Astrazeneca KK, Nippon Boehringer Ingelheim, and Abbot Japan Co; unrestricted grants from GlaxoSmithKline KK, Nippon Boehringer Ingelheim, and Novartis Pharma KK. MI has received honoraria, consultancy fees, and/or research grants from GlaxoSmithKline KK, Nippon Boehringer Ingelheim, Novartis Pharma KK, Abbot Japan Co, and Astrazeneca KK. YF has acted as a paid consultant to Novartis Pharma KK and has previously served as a paid member of the scientific advisory board for Novartis Pharma KK. MH, NO, NP and BK are employees of Novartis.
Efficacy and safety of indacaterol 150 and 300 µg in chronic obstructive pulmonary disease patients from six Asian areas including Japan: A 12-week, placebo-controlled study
Article first published online: 24 JAN 2012
© 2011 Novartis Pharma AG (Basel, Switzerland)
Volume 17, Issue 2, pages 379–389, February 2012
How to Cite
KINOSHITA, M., LEE, S. H., HANG, L.-W., ICHINOSE, M., HOSOE, M., OKINO, N., PRASAD, N., KRAMER, B., FUKUCHI, Y. and FOR THE INDACATEROL ASIAN COPD STUDY INVESTIGATORS (2012), Efficacy and safety of indacaterol 150 and 300 µg in chronic obstructive pulmonary disease patients from six Asian areas including Japan: A 12-week, placebo-controlled study. Respirology, 17: 379–389. doi: 10.1111/j.1440-1843.2011.02107.x
- Issue published online: 24 JAN 2012
- Article first published online: 24 JAN 2012
- Accepted manuscript online: 28 NOV 2011 11:21AM EST
- Received 21 July 2011; invited to revise 16 August 2011, 18 September 2011; revised 14 September 2011, 7 October 2011; accepted 7 October 2011 (Associate Editor: David Hui).
- Asian population;
Background and objective: The efficacy and safety of indacaterol, a novel inhaled once daily ultra long-acting β2-agonist was evaluated in COPD patients in six Asian countries/areas. This study was primarily designed to obtain the regulatory approval of indacaterol in Japan.
Methods: Moderate-to-severe COPD patients were randomized to indacaterol 150 µg, indacaterol 300 µg or placebo once daily. Efficacy variables: trough FEV1 (average of 23 h 10 min and 23 h 45 min post-dose values), health status (St. George's Respiratory Questionnaire) and transition dyspnoea index at week 12. Safety/tolerability was evaluated.
Results: A total of 347 patients were randomized (96.5% male, mean (SD) age 66.7 (8.38) years, post-bronchodilator FEV1% predicted: 53.7 (12.50)); 88.8% completed. The least squares means (LSM) trough FEV1 at week 12 for indacaterol 150 µg, indacaterol 300 µg and placebo were 1.34 L, 1.37 L and 1.17 L, respectively, with differences versus placebo exceeding the prespecified minimal clinically important difference of 0.12 L (0.17 L and 0.20 L for indacaterol 150 µg and 300 µg, respectively, both P < 0.001). The week 12 LSM transition dyspnoea index score was statistically superior for both indacaterol doses versus placebo (differences of 1.30 and 1.26, P < 0.001; both exceeding the minimal clinically important difference of 1). At week 12, both indacaterol doses provided statistically significant (P ≤ 0.005) and clinically meaningful (≥4 units) improvements in LSM St. George's Respiratory Questionnaire total score versus placebo (differences: −4.8 and −5.7 units). Adverse events for indacaterol (49.1%, both doses) were lower than placebo (59.0%) and were mostly mild/moderate in severity; no deaths were reported.
Conclusions: Indacaterol provided clinically significant bronchodilation and improvements in dyspnoea and health status in Asian COPD patients.