Sustained 24-hour efficacy of once daily indacaterol (300 μg) in patients with chronic obstructive pulmonary disease: a randomized, crossover study.

Abstract Purpose Indacaterol is a novel, once daily, inhaled ultra-long-acting β 2 -agonist for the treatment of chronic obstructive pulmonary disease (COPD). Here we compared the 24-h spirometry profile of once daily indacaterol 300 μg with that of placebo and twice daily salmeterol 50 μg in patients with COPD. Methods This randomized, multicenter, placebo-controlled, crossover study comprised three 14-day treatment periods (with 14-day washouts). Patients (male/female ≥40 years) with moderate-to-severe COPD were randomized to receive double-blind indacaterol 300 μg or placebo once daily, or open-label salmeterol 50 μg twice daily. The primary outcome measure was 24-h post-dose (trough) FEV 1 (mean of FEV 1 at 23 h 10 min and 23 h 45 min post-indacaterol dose) after 14 days. FEV 1 was assessed at multiple time points on Days 1 and 14 of each treatment period. Safety and tolerability were also monitored. Results Of 68 randomized patients, 61 completed. Trough FEV 1 (primary endpoint) on Day 14 for indacaterol was 200 mL higher than placebo ( p p  = 0.011). After Day 1, trough FEV 1 for indacaterol was 150 mL higher than placebo ( p p 1 compared with salmeterol ( p Conclusions Once daily indacaterol 300 μg produced effective sustained 24-h bronchodilation from the first dose, an efficacy profile superior to placebo and twice daily salmeterol. Given its effective bronchodilation with once daily dosing, indacaterol is likely to be a useful treatment option for patients with moderate-to-severe COPD.