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To assess the bronchodilator efficacy, safety and tolerability of indacaterol, a novel, once-daily inhaled beta(2)-agonist bronchodilator, in patients with chronic obstructive pulmonary disease (COPD).This crossover, double-blind, double-dummy study was conducted to evaluate the 24-h bronchodilator effect of a range of single doses of indacaterol (150 microg, 300 microg and 600 microg), given in the morning via single-dose dry powder inhaler (SDDPI) in subjects with COPD, compared with placebo and with the daily therapeutic dose of formoterol (two 12 microg doses 12 h apart, via an SDDPI). Tolerability and safety were also assessed.Fifty-one subjects with moderate-to-severe COPD received each of the five treatments on separate study days in randomised sequence. The 24-h trough FEV(1) (primary endpoint; mean [95% CI]) was 1.46 (1.43, 1.49) L with indacaterol 600 microg (p0.001 vs. placebo, p0.01 vs. formoterol, p0.05 vs. indacaterol 150 microg), 1.45 (1.42, 1.48) L with indacaterol 300 microg (p0.001 vs. placebo, p0.05 vs. formoterol), 1.42 (1.39, 1.45) L with indacaterol 150 microg (p0.001 vs. placebo), 1.41 (1.38, 1.43) L with formoterol (p0.001 vs. placebo) and 1.28 (1.25, 1.31) L with placebo. All treatments were well tolerated and there was little effect on serum potassium, blood glucose or QTc interval.All doses of indacaterol were effective in providing 24-h bronchodilation and were well-tolerated in subjects with COPD. The bronchodilator efficacy of indacaterol (150, 300 and 600 microg) at 24 h post-dose was at least as efficacious as formoterol 12 microg twice daily.

BACKGROUND Glycopyrronium is a once-daily (od) long-acting muscarinic antagonist for the maintenance treatment of chronic obstructive pulmonary disease (COPD). The GLOW7 study evaluated the efficacy and safety of od glycopyrronium 50 μg in predominantly Chinese patients with moderate-to-severe COPD. METHODS In this 26-week, multi-center, double-blind, placebo-controlled, parallel-group study, men and women ≥40 years with moderate-to-severe COPD were randomized to glycopyrronium 50 μg od or placebo (2:1). The primary objective was to confirm the significant improvement of trough forced expiratory volume in 1 second (FEV1) following 12 weeks of treatment with glycopyrronium compared with placebo. Secondary objectives included the effect of glycopyrronium on health status (St George's Respiratory Questionnaire), breathlessness (Transition Dyspnea Index), other lung function parameters, rescue medication use, and COPD exacerbations. Safety and tolerability were also evaluated. RESULTS Of the 460 patients randomized, 459 were included in the full analysis set (glycopyrronium, n=306; placebo, n=154; mean age 64.7 years; mean post-bronchodilator FEV1: 50.8% predicted); 425 (92.4%) completed the study. At Week 12, glycopyrronium signifcantly improved trough FEV1 with a least square means treatment difference of 141 mL (95% confidence interval 111 mL, 171 mL; P