Long-term Safety and Efficacy of Indacaterol, a Long-Acting β2-Agonist, in Subjects With COPD A Randomized, Placebo-Controlled Study

Background: Indacaterol is an inhaled, long-acting beta(2)-agonist providing 24-h bronchodilation with once-daily dosing in patients with COPD. Methods: Subjects with moderate to severe COPD who completed a 26-week, randomized, double-blind study were eligible for enrollment in an extension, during which treatment with double-blind indacaterol, 150 or 300 mu g once daily, or placebo was continued for a further 26 weeks. The primary objective was to evaluate the long-term safety of indacaterol. Efficacy end points included trough (24 h postdose) FEV1 at 52 weeks, exacerbations, and health status (St. George Respiratory Questionnaire [SGRQ]). Results: Four hundred fifteen subjects participated in the extension. Adverse events, mostly mild or moderate, occurred in 76%, 77%, and 68% of subjects receiving indacaterol, 150 mu g; indacaterol, 300 mu g; and placebo, respectively. Serious adverse events occurred in 10.4%, 12.3%, and 10.5%, respectively. Indacaterol had no clinically significant effects on ECG findings (corrected QT interval) or on serum potassium or plasma glucose levels. Indacaterol increased trough FEV1 relative to placebo throughout the study (difference of >= 170 mL at week 52). No tolerance to its bronchodilator effect was detected. Indacaterol treatment was accompanied by significant reductions in COPD exacerbations (rate ratios compared with placebo, 0.62-0.64; P < .05) and as-needed albuterol use (1.2-1.4 puffs/d decrease, P < .001 compared with placebo). Health status improved with indacaterol treatment, with decreases from baseline in mean total SGRQ score generally >4 units. Conclusions: During 1 year of treatment, indacaterol was well tolerated and provided significant and well-maintained bronchoililation that was accompanied by improved clinical outcomes. Trial registry: ClinicalTrials.gov; No.: NCT00677807; URL: www.clinicaltrials.gov CHEST 2011; 140(1):68-75