Dual Bronchodilation With Once-Daily QVA149 Reduces Exacerbations, Improves Lung Function and Health Status Versus Glycopyrronium and Tiotropium in Severe-to-Very Severe COPD Patients: The SPARK Study

Abstract

SESSION TITLE: COPD QVA149 PostersSESSION TYPE: Poster PresentationsPRESENTED ON: Saturday, March 22, 2014 at 01:15 PM - 02:15 PMPURPOSE: Patients with severe-to-very severe COPD require intensified therapy to reduce risk of exacerbations. Such patients may benefit from additional bronchodilation. Once-daily QVA149 is a dual bronchodilator consisting of a fixed-dose combination of two long-acting bronchodilators, indacaterol and glycopyrronium. METHODS: The 64-week SPARK study randomized patients to QVA149 110/50[mu]g or Glycopyrronium 50[mu]g, both via the Breezhaler(R) device; or open-label tiotropium (18[mu]g via the Handihaler(R) device). Objectives were rate of COPD exacerbations, lung function, health status, and safety. RESULTS: 2224 patients were randomized, out of which 63.3% patients completed the study. Rate of all COPD exacerbations was significantly reduced with QVA149 versus glycopyrronium (rate ratio [RR] 0.85, 95% CI: 0.77, 0.94; p=0.001) and tiotropium (RR 0.86, 95% CI: 0.78, 0.94; p=0.002). QVA149 had clinically meaningful and statistically significant improvement in pre- and post-dose FEV1 versus glycopyrronium and tiotropium for all visits (all p0.001); there were significant improvements in SGRQ score at Week 64 versus glycopyrronium (p0.01) and tiotropium (p0.001). Frequency of adverse and cardio/cerebrovascular events was similar across all treatment groups. CONCLUSIONS: Superior improvements in lung function with QVA149 leads to fewer exacerbations and improved health status versus glycopyrronium and tiotropium in patients with severe-to-very severe COPD. QVA149 was safe and well tolerated. CLINICAL IMPLICATIONS: QVA149 is a safe and better choice of treatment for improving lung function, reducing COPD exacerbations and improving respiratory health status compared to glycopyrronium and tiotropium in patients with severe-to-very severe COPD. DISCLOSURE: Jadwiga 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. Joachim Ficker: Consultant fee, speaker bureau, advisory committee, etc.: Dr. Ficker has received speaker fees from AstraZeneca, GlaxoSmithKline, Boehringer Ingelheim, Pfizer, Nycomed, Almirall, Berlin-C hemie, Takeda and Novartis, consulting fees from AstraZeneca, Boehringer Ingelheim, and Novartis. Angel FowlerTaylor: Employee: The author is an employee of Novartis Pharmaceuticals Corporation Donald Banerji: Employee: The author is an employee of Novartis Pharmaceuticals Corporation The following authors have nothing to disclose: Dennis Niewohner, Thomas SandströmClinical 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.