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Purpose: Indacaterol is a novel, once-daily (od), inhaled, long-acting β2-agonist for treatment of chronic obstructive pulmonary disease (COPD). We analyzed pooled efficacy and safety data from two identically designed, randomized, double-blind, placebo-controlled, phase III trials in patients with moderate-to-severe COPD.
Methods: Patients received indacaterol 75 μg od (n=322) or matching placebo (n=318) for 12 weeks. The primary efficacy variable was trough FEV1 (mean of values at 23 h 10 min and 23 h 45 min post dose), at Week 12. Key secondary efficacy variable was transition dyspnea index (TDI) total score, after 12 weeks. Additional efficacy data (rescue albuterol use, health-related quality of life [HRQoL; St George’s Respiratory Questionnaire, SGRQ]) and safety were collected.
Results: At baseline, mean age was 62.7 years with post-albuterol FEV1 54.0% predicted; 41.4% of patients were taking inhaled corticosteroids. Indacaterol 75 μg increased trough FEV1 at Week 12 by clinically relevant amounts (≥120 mL; p<0.001 vs placebo).Indacaterol-treated patients had significantly (p<0.001) reduced use of rescue albuterol and decreased dyspnea versus placebo. In addition, SGRQ total score was significantly lower (better HRQoL) with indacaterol (p<0.001 versus placebo). The overall incidence of adverse events (AEs) was similar between indacaterol (46.9%) and placebo (43.9%). Serious AEs occurred in 2.5% and 4.1% of indacaterol and placebo patients, respectively, with two deaths (0.6%) in the placebo group. Notable serum potassium (<3.0 mmol/L) occurred in 0.3% of patients in both groups, while notable blood glucose (>9.99 mmol/L) was reported in 5.3% of indacaterol-treated and 7.8% of placebo-treated patients. There were no reports of QTc interval >60 ms (Fridericia).
Conclusion: In this pooled analysis, indacaterol 75 μg od provided effective 24-hour bronchodilation, improved HRQoL, reduced use of rescue medication, and improved dyspnea versus placebo. Indacaterol had a safety profile similar to placebo in patients with moderate-to-severe COPD.