TY - JOUR T1 - Once-daily indacaterol vs twice-daily salmeterol for COPD: a placebo-controlled comparison JF - European Respiratory Journal JO - Eur Respir J DO - 10.1183/09031936.00045810 SP - erj00458-2010 AU - O. Kornmann AU - R. Dahl AU - S. Centanni AU - A. Dogra AU - R. Owen AU - C. Lassen AU - B. Kramer Y1 - 2010/01/01 UR - http://erj.ersjournals.com/content/early/2010/08/06/09031936.00045810.abstract N2 - Indacaterol is a novel, inhaled, once-daily, ultra-long-acting β2-agonist bronchodilator, recently approved in Europe for the treatment of COPD. This study set out to investigate the efficacy and safety of indacaterol compared with placebo and the twice-daily β2-agonist, salmeterol, as an active control.Patients with moderate-to-severe COPD were randomized to 6 months' double-blind treatment with indacaterol 150 μg once daily, salmeterol 50 μg twice daily or placebo. Primary efficacy endpoint was trough (24 h post-dose) forced expiratory volume in 1 s (FEV1) after 12 weeks.1002 patients were randomized and 838 (84%) completed the study. Indacaterol increased trough FEV1 at Week 12 by 170 mL over placebo (p<0.001), and by 60 mL more than salmeterol (p<0.001). Both active treatments improved health status (St George's Respiratory Questionnaire) and dyspnoea (transition dyspnoea index) compared with placebo, with differences between them favouring indacaterol. Safety profiles were similar across the treatment groups and both indacaterol and salmeterol were well tolerated.Once-daily treatment with indacaterol 150 μg has a significant and clinically relevant bronchodilator effect over 24 h post-dose, and improves health status and dyspnoea to a greater extent than twice-daily salmeterol 50 μg. Indacaterol should prove a useful additional treatment for patients with COPD. ER -