• Jørgen Vestbo, Nicola Gallagher, Donald Banerji, and Jadwiga Wedzicha.
• Chest. 2014 Mar 1;145(3 Suppl):408A.

Session TitleCOPD QVA149 PostersSESSION TYPE: Poster PresentationsPRESENTED ON: Saturday, March 22, 2014 at 01:15 PM - 02:15 PMPURPOSE: Current COPD treatment guidelines recommend long-acting β2-agonist/inhaled corticosteroids (LABA/ICS) for severe COPD patients with a history of exacerbations. The 26-week ILLUMINATE study in moderate-to-severe COPD patients showed superiority of QVA149 versus the LABA/ICS salmeterol/fluticasone combination (SFC) in lung function. A novel study design to evaluate the effect of QVA149 versus SFC on COPD exacerbations in more severe patients with a history of exacerbations is presented.MethodsThis multicenter, double-blind, active-controlled study will randomize ~3332 patients with moderate-to-very severe COPD (1:1) to once-daily QVA149 (110μg indacaterol/50μg glycopyrronium) or twice-daily SFC (50/500μg) for 52 weeks. The study will have a 1-week screening, a 4-week run-in where tiotropium rather than rescue therapy alone will be provided to all patients, a 52-week blinded treatment, and a 30-day follow-up period. Patients ≥40 years, history of ≥1 COPD exacerbations 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.ResultsPrimary objective: to show that QVA149 is non-inferior to SFC for annual rate of all COPD exacerbations (mild/moderate/severe). Secondary outcomes: evaluating potential superiority of QVA149 versus SFC for annual rate of all exacerbations time to first COPD exacerbations, lung function, health status, safety and tolerability.ConclusionsThis study should provide the first evidence about the long-term effect of QVA149 on reduction of COPD exacerbations when compared with LABA/ICS in patients with a history of exacerbations. In addition, the data from the study should provide more evidence on additional benefits of LABA/long-acting muscarinic antagonist (LAMA) QVA149 over LABA/ICS in terms of improvements in lung function, health status, rescue medication use and safety in patients with COPD.Clinical ImplicationsThe results from this study should elucidate the potential place in therapy for dual bronchodilation with QVA149 versus LABA/ICS in a moderate-to-very severe COPD population with a history of exacerbations.DisclosureJadwiga Wedzicha: Consultant fee, speaker bureau, advisory committee, etc.: JW has received speaking fee and/or for advisory boards from GlaxoSmithKline, AstraZeneca, Novartis, Bayer, Boehringer Ingelheim, Nycomed. Chiesi and Respifor as well as travel reimbursements from Boehringer Ingelheim. JW has received research grants from GlaxoSmithKline, AstraZeneca, Chiesi and Novartis. Nicola Gallagher: Employee: Novartis employee Donald Banerji: Employee: Novartis employee The following authors have nothing to disclose: Jørgen VestboClinical trial results of QVA149, combination of two approved products indacaterol and glycopyrronium, will be presented, QVA is in the late stage phase 3 trials prior to approval.

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