Indacaterol is a novel, once-daily (qd), inhaled long-acting β2-agonist. This study characterized the 24-h lung function profile of indacaterol compared to placebo and open-label salmeterol in patients with COPD. The primary objective was to assess the superiority of indacaterol (300αg qd) over placebo in terms of 24-h post-dose (trough) FEV1 (mean of 23h 10min and 23h 45min post-dose values) after 14 days of treatment.
Randomized, Phase III, three-period crossover study (14-day treatment periods with 14-day washouts between treatments). Patients (male/female ≥ 40 years) with moderate-to-severe COPD, smoking history ≥ 20 pack-years, post-bronchodilator FEV1 ≥ 30% but < 80% predicted, and FEV1/FVC < 70% were randomized to receive double-blind indacaterol 300μg or placebo qd via single-dose dry powder inhaler, or open-label salmeterol 50μg bid via multidose dry powder inhaler. FEV1 was assessed pre-dose and at 5, 15, and 30min and 1, 2, 3, 4, 5, 6, 8, and 10h, 11h 10min, 11h 45min, 14h, 20h 10min, 20h 45min, 22h, 23h 10min, and 23h 45min post-dose on Days 1 and 14 of each treatment period. Safety and tolerability were monitored.
Of the 68 patients randomized, 61 completed the study. After 14 days, trough FEV1 for indacaterol was 200mL higher than placebo (P < 0.001), exceeding the minimum clinically important difference (120mL), and 90mL higher than salmeterol (P = 0.011). Trough FEV1 was higher for indacaterol versus placebo after Day 1 (indacaterol–placebo difference: 150mL; P < 0.001). Indacaterol provided superior bronchodilation compared to placebo (P < 0.001) across the full 24-h assessment period on Days 1 and 14. In addition, on both days, indacaterol provided superior FEV1 compared to salmeterol (P < 0.05) at many post-baseline time points, including 5 min post-dose. All treatments were well tolerated.
Once-daily indacaterol 300μg produced effective bronchodilation that was sustained over 24 hours from the first dose, with efficacy greater than twice-daily salmeterol.
As an effective bronchodilator, once-daily indacaterol will be a useful treatment option for patients with moderate-to-severe COPD.
Craig LaForce, No Financial Disclosure Information; No Product/Research Disclosure Information