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

Background and objective: The efficacy and safety of indacaterol, a novel inhaled once daily ultra long-acting beta(2)-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 mu g, indacaterol 300 mu g or placebo once daily. Efficacy variables: trough FEV(1) (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 FEV(1)% predicted: 53.7 (12.50)); 88.8% completed. The least squares means (LSM) trough FEV(1) at week 12 for indacaterol 150 mu g, indacaterol 300 mu g 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 mu g and 300 mu g, 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.