TY - JOUR T1 - Once-daily QVA149 reduces exacerbations and improves health status in comparison with glycopyrronium and tiotropium in patients with severe-to-very severe COPD: The SPARK study JF - European Respiratory Journal JO - Eur Respir J VL - 42 IS - Suppl 57 SP - P756 AU - Marc Decramer AU - Jadwiga A. Wedzicha AU - Joachim H. Ficker AU - Angel FowlerTaylor AU - Peter D'Andrea AU - Christie Arrasate AU - Hungta Chen AU - Donald Banerji Y1 - 2013/09/01 UR - http://erj.ersjournals.com/content/42/Suppl_57/P756.abstract N2 - IntroductionQVA149 is a once-daily dual bronchodilator containing a fixed-dose combination of the long-acting β2-agonist (indacaterol) and long-acting muscarinic antagonist glycopyrronium (GLY), for the treatment of COPD. We evaluated the overall rate of exacerbations and the health status with QVA149 in comparison with GLY and tiotropium (TIO).MethodsIn this 64-week multicenter study, patients aged ≥40 yrs with severe-to-very severe COPD were randomized to receive once-daily, double-blind QVA149 110/50 μg, GLY 50 μg, or open-label TIO 18 μg. Overall exacerbation rates and health status via the St George’s Respiratory Questionnaire (SGRQ) scores were determined.ResultsOf 2224 patients randomized, 75% of patients completed the study. QVA149 resulted in a rate reduction of 15% versus GLY (Rate ratio [RR] 0.85; 95% CI 0.77–0.94; p=0.001) and 14% versus TIO (RR 0.86; 95% CI 0.78–0.94; p≤0.01). SGRQ total score was significantly improved with QVA149 at Week 64 compared with both GLY (mean difference –2.07; p<0.01) and TIO (mean difference –2.69; p<0.001). SGRQ symptoms, activity and impacts component scores also showed greater improvement with QVA149 than with GLY or TIO at all visits.ConclusionOnce-daily QVA149 was superior to glycopyrronium and tiotropium in lowering the rate of exacerbations and similarly provided significant and clinically meaningful improvements in health status (SGRQ) in patients with severe-to-very severe COPD. ER -