RT Journal Article SR Electronic T1 Once-daily indacaterol versus twice-daily salmeterol for COPD: a placebo-controlled comparison JF European Respiratory Journal JO Eur Respir J FD European Respiratory Society SP 273 OP 279 DO 10.1183/09031936.00045810 VO 37 IS 2 A1 O. Kornmann A1 R. Dahl A1 S. Centanni A1 A. Dogra A1 R. Owen A1 C. Lassen A1 B. Kramer YR 2011 UL http://erj.ersjournals.com/content/37/2/273.abstract AB Indacaterol is a novel, inhaled, once-daily, ultra-long-acting β2-agonist bronchodilator recently approved in Europe for the treatment of chronic obstructive pulmonary disease (COPD). The aim of the present study was 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 randomised to 6 months double-blind treatment with indacaterol (150 μg once daily), salmeterol (50 μg twice daily) or placebo. The primary efficacy end-point was trough (24 h post-dose) forced expiratory volume in 1 s (FEV1) after 12 weeks. 1,002 patients were randomised 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 over 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 150 μg indacaterol had a significant and clinically relevant bronchodilator effect over 24 h post-dose and improved health status and dyspnoea to a greater extent than twice-daily 50 μg salmeterol. Indacaterol should prove a useful additional treatment for patients with COPD.