QVA149 Improves Lung Function and Reduces Exacerbations Compared With Tiotropium in Patients With Severe-to-Very Severe COPD: The SPARK Study

Abstract

SESSION TITLE: COPD QVA149 PostersSESSION TYPE: Poster PresentationsPRESENTED ON: Saturday, March 22, 2014 at 01:15 PM - 02:15 PMPURPOSE: Sustained bronchodilation is thought to contribute to the reduction in exacerbations in patients with chronic obstructive pulmonary disease (COPD). Here we evaluate the effect of once-daily QVA149, a dual bronchodilator fixed-dose combination of indacaterol and glycopyrronium, on lung function and exacerbation rates in comparison with tiotropium. METHODS: Patients aged >=40 years with severe-to-very severe COPD were randomized to receive double-blind QVA149 110/50 [mu]g or glycopyrronium 50 [mu]g, or open-label tiotropium 18 [mu]g. The treatment period was 64 weeks followed by a variable exposure up to 76 weeks. Post-dose forced expiratory volume in 1 s (FEV1) at 30 min and 1 h post-dose at weeks 1, 4, 12, 26, 38, 52, 64, and 76 and exacerbation rates were analyzed. RESULTS: Of the patients randomized to QVA149 (n=741) and tiotropium (n=742), 77% and 75% patients completed the study, respectively. The least squares mean (LSM) treatment difference of post-dose FEV1 significantly favored QVA149 over tiotropium at all visits (p0.001). Thirty min post-dose, the LSM range of improvement over the entire 76 weeks was 1.07 to 1.19 L for QVA149 and 1.00 to 1.09 L for tiotropium, with LSM treatment difference of 0.08 to 1.12 L for QVA149 versus tiotropium. One hour post-dose, the LSM range of improvement was 1.09 to 1.21 L for QVA149 and 1.01 to 1.09 L for tiotropium, with the LSM treatment difference of 0.04 to 0.14 L for QVA149 versus tiotropium. Improvements in lung function translated to lower exacerbation rate with QVA149 versus tiotropium (Rate Ratio 0.86; 95% CI 0.78-0.94; p0.01). CONCLUSIONS: Superior improvements in lung function with QVA149 resulted in a significant reduction in exacerbations compared with tiotropium over 76 weeks in patients with severe-to-very severe COPD. CLINICAL IMPLICATIONS: The results of the SPARK study indicate the potential of dual bronchodilation as a treatment option for patients with severe and 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. Angel FowlerTaylor: Employee: Novartis employee Peter D'Andrea: Employee: Novartis employee Christie Arrasate: Employee: Novartis employee Hungta Chen: Employee: Novartis employee Donald Banerji: Employee: Novartis employee The following authors have nothing to disclose: Joachim FickerNo Product/Research Disclosure Information.