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 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 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 (acircyen4 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. This placebo-controlled, parallel-group study evaluated the efficacy and safety of indacaterol in COPD patients from six Asian countries/areas. Trough FEVbsubesub, health status, dyspnoea, and safety were evaluated. Significant bronchodilation and improvements in patient-reported outcomes indicate that indacaterol is a useful treatment option for Asian patients with moderate-to-severe COPD.
ASJC Scopus subject areas
- Pulmonary and Respiratory Medicine