• Donald Banerji, Karen Mezzi, and Mark Fedele.
• Chest. 2014 Mar 1;145(3 Suppl):402A.

Session TitleCOPD QVA149 PostersSESSION TYPE: Poster PresentationsPRESENTED ON: Saturday, March 22, 2014 at 01:15 PM - 02:15 PMPURPOSE: The IGNITE program investigated the efficacy and safety of dual bronchodilation with once-daily QVA149 [fixed-dose combination of indacaterol (long-acting β2-agonist) and glycopyrronium (long-acting muscarinic antagonist)] for the treatment of patients with moderate-to-severe COPD.MethodsHere we present an overview from 5 IGNITE trials: ARISE (Japanese safety study), SHINE, ILLUMINATE, SPARK and BLAZE, reporting lung function, transitional dyspnea index (TDI), health status (via the St George Respiratory Questionnaire [SGRQ]), exacerbations, and safety data in a population of 5298 patients with moderate-to-very severe COPD.ResultsQVA149 provided statistically significant and sustained bronchodilation (p<0.001) versus all comparators. The mean change from baseline in pre-dose forced expiratory volume in 1 second (FEV1) was 189 and 52 mL for the QVA149 and tiotropium group, respectively at Week 52 in the ARISE study. In the ILLUMINATE study, FEV1 AUC0-12h for QVA149 was significantly higher versus salmeterol/fluticasone combination, with a significant and clinically meaningful treatment difference of 0.138 L (95% confidence interval [CI] 0.100-0.176; p<0.0001). In the BLAZE study, the least squares mean treatment difference in TDI score was 0.49 (95% CI 0.07, 0.91; p=0.021) and 1.37 (95% CI 0.95, 1.79; p<0.001) for QVA149 versus tiotropium and placebo, respectively. QVA149 decreased the rate of overall COPD exacerbations by 15% (rate ratio [RR] 0.85; 95% CI 0.77, 0.94; p=0.001) and 14% (RR 0.86; 95% CI 0.78, 0.94; p=0.002), versus glycopyrronium and tiotropium, respectively in the SPARK study. Moreover, QVA149 significantly improved SGRQ total score versus glycopyrronium (treatment difference: -2.07; p=0.07) and tiotropium (-2.69; p<0.001). In all studies, QVA149 was safe and well tolerated.ConclusionsDual bronchodilation with once-daily QVA149 demonstrated improvements in lung function, dyspnea and health status and reduction in exacerbations, along with a favorable safety profile in patients with COPD.Clinical ImplicationsThe results from the IGNITE trials support the potential for once-daily QVA149 as a valuable therapeutic option for patients with moderate-to-very severe COPD providing additional benefits versus glycopyrronium, and standard of care tiotropium and salmeterol/fluticasone combination.DisclosureKaren Mezzi: Employee: Novartis Employee Mark Fedele: Employee: Novartis Employee Hungta Chen: Employee: Novartis Employee Donald Banerji: Employee: Novartis EmployeeClinical trial results of QVA149, combination of two approved products indacaterol and glycopyrronium, will be presented, QVA149 is in the late stage phase 3 trials prior to approval.

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