TY - JOUR T1 - Dual bronchodilation with QVA149 <em>versus</em> single bronchodilator therapy: the SHINE study JF - European Respiratory Journal JO - Eur Respir J DO - 10.1183/09031936.00200212 SP - erj02002-2012 AU - Eric D Bateman AU - Gary T Ferguson AU - Neil Barnes AU - Nicola Gallagher AU - Yulia Green AU - Michelle Henley AU - Donald Banerji Y1 - 2013/01/01 UR - http://erj.ersjournals.com/content/early/2013/05/30/09031936.00200212.abstract N2 - We investigated the efficacy and safety of dual bronchodilation with QVA149 versus its mono-components indacaterol and glycopyrronium, and tiotropium and placebo in patients with moderate-to-severe COPD.This was a multicentre, randomised, double-blind, placebo- and active-controlled, 26-week trial. Patients (n=2144) were randomised (2:2:2:2:1) to once-daily QVA149 110/50 μg, indacaterol 150 μg, glycopyrronium 50 μg, open-label tiotropium 18 μg or placebo. The primary endpoint was trough FEV1 at Week 26 for QVA149 versus its mono-components. Secondary endpoints included dyspnoea, health status, rescue medication use and safety.Trough FEV1 at Week 26 was significantly improved (p&lt;0.001) with QVA149 compared with indacaterol and glycopyrronium (least squares mean [LSM] differences: 0.07 L and 0.09 L, respectively), tiotropium and placebo (LSM differences: 0.08 L and 0.20 L, respectively); these beneficial effects were sustained throughout the 26-week study. QVA149 significantly improved dyspnoea and health status versus placebo (p&lt;0.001 and p=0.002, respectively) and tiotropium (p=0.007 and p=0.009, respectively) at Week 26. All treatments were well tolerated.Dual bronchodilation with once-daily QVA149 demonstrated superior and clinically meaningful outcomes versus placebo and superiority versus treatment with a single bronchodilator, with a safety and tolerability profile similar to placebo, supporting the concept of fixed-dose LAMA/LABA combinations for the treatment of COPD. ER -