Indacaterol once-daily provides superior efficacy to salmeterol twice-daily in COPD: A 12-week study

Summary Background Indacaterol is a novel, inhaled once-daily ultra-long-acting β2 -agonist for the treatment of COPD. Methods This 12-week randomised, parallel-group study compared the efficacy of indacaterol 150 μg once-daily to salmeterol 50 μg twice-daily in patients with moderate-to-severe COPD. Assessments included FEV1 standardised area under curve (AUC) from 5 min to 11 h 45 min at Week 12 (primary endpoint), 24-h trough FEV1 (mean of 23 h 10 min and 23 h 45 min post-dose) at Week 12 (key secondary endpoint), FEV1 and FVC measured over 24-h, transition dyspnoea index (TDI) and rescue medication use. Results Of 1123 patients randomised 92.1% completed. Mean ± SD age was 62.8 ± 8.78 years, post-bronchodilator FEV1 51.8 ± 12.32% predicted, FEV1 /FVC 50.6 ± 9.54%. At Week 12, FEV1 AUC5 min–11 h 45 min for indacaterol was statistically superior ( p