PT - JOURNAL ARTICLE AU - Edward Kerwin AU - Jacques Hébert AU - Nicola Gallagher AU - Carmen Martin AU - Tim Overend AU - Vijay K.T. Alagappan AU - Yimeng Lu AU - Donald Banerji TI - Efficacy and safety of NVA237 <em>versus</em> placebo and tiotropium in patients with COPD: the GLOW2 study AID - 10.1183/09031936.00040712 DP - 2012 Nov 01 TA - European Respiratory Journal PG - 1106--1114 VI - 40 IP - 5 4099 - http://erj.ersjournals.com/content/40/5/1106.short 4100 - http://erj.ersjournals.com/content/40/5/1106.full SO - Eur Respir J2012 Nov 01; 40 AB - NVA237 (glycopyrronium bromide) is a once-daily long-acting muscarinic antagonist (LAMA) in development for chronic obstructive pulmonary disease (COPD). The GLycopyrronium bromide in COPD airWays clinical Study 2 (GLOW2) evaluated the efficacy and safety of NVA237 in moderate-to-severe COPD over 52 weeks.Patients were randomised 2:1:1 to NVA237 50 μg, placebo or open-label tiotropium 18 μg for 52 weeks. Primary end-point was trough forced expiratory volume in 1 s (FEV1) at 12 weeks.1,066 patients were randomised, 810 completed the study. At week 12, trough FEV1 increased significantly by 97 mL with NVA237 (95% CI 64.6–130.2; p&lt;0.001) and 83 mL with tiotropium (95% CI 45.6–121.4; p&lt;0.001). Compared with placebo, NVA237 produced significant improvements in dyspnoea (Transition Dyspnoea Index at week 26; p=0.002) and health status (St George's Respiratory Questionnaire at week 52; p&lt;0.001). NVA237 significantly reduced the risk of moderate-to-severe COPD exacerbations by 34% (p=0.001) and the use of rescue medication (p=0.039), versus placebo. NVA237-placebo and tiotropium-placebo differences were comparable for all outcomes. Safety profiles were similar across groups.NVA237 50 μg provided significant improvements in lung function, dyspnoea, health status, exacerbations and rescue medication use, versus placebo, and was comparable to tiotropium. NVA237 can potentially be an alternative choice of LAMA for COPD patients.