TY - JOUR T1 - A novel study design for the comparison between once-daily QVA149 and twice-daily salmeterol/fluticasone on the reduction of COPD exacerbations: The FLAME study JF - European Respiratory Journal JO - Eur Respir J VL - 42 IS - Suppl 57 SP - P696 AU - Jadwiga A. Wedzicha AU - Marc Decramer AU - Jørgen Vestbo AU - Nicola Gallagher AU - Han-Joo Kim AU - Danny McBryan AU - Donald Banerji Y1 - 2013/09/01 UR - http://erj.ersjournals.com/content/42/Suppl_57/P696.abstract N2 - IntroductionCurrent COPD treatment guidelines recommend LABA/ICS for severe COPD patients (pts) with a history of exacerbations (exac). The 26wk ILLUMINATE study in moderate-to-severe COPD pts showed superiority of QVA149 vs. the LABA/ICS salmeterol/fluticasone (SFC) in lung function.1 A novel study design to evaluate the effect of QVA149 vs. SFC on COPD exac in more severe pts with a history of exac is presented.MethodsThis multicenter, double-blind, active-controlled study will randomize ∼3332 pts with moderate-to-very severe COPD (1:1) to once-daily QVA149 (110μg indacaterol/50μg glycopyrronium) or twice-daily SFC (50/500μg) for 52wks. The study will have a 1wk screening, a 4wk run-in where tiotropium rather than rescue therapy alone will be provided to all pts, a 52wk blinded treatment, and a 30 day follow-up period. Pts ≥40yrs, history of ≥1 COPD exac in the past 12 months requiring systemic glucocorticosteroids and/or antibiotics and post-bronchodilator forced expiratory volume in 1 second ≥25 and <60% predicted value will be included. Primary objective: to show that QVA149 is non-inferior to SFC for annual rate of all COPD exac (mild/moderate/severe). Secondary outcomes: evaluating potential superiority of QVA149 vs. SFC for annual rate of all exac, time to first COPD exac, lung function, health status, safety and tolerability.ConclusionThe results from this study should elucidate the potential place in therapy for dual bronchodilation with QVA149 vs. LABA/ICS in a moderate-to-very severe COPD population with a history of exacerbations.Reference1. Vogelmeier, C.F. et al. The Lancet Resp Med, online Dec 6, 2012. ER -