Umeclidinium in patients with COPD: a randomised, placebo-controlled study

Efficacy and safety of umeclidinium (UMEC) administered in a dry power inhaler were evaluated in moderate-to-very-severe COPD patients. Randomised, placebo-controlled study assessing once-daily UMEC 62.5 and 125 mcg over 12 weeks. Primary end-point: change from baseline in trough FEV1 on day 85. Secondary end-points: 0–6 h weighted mean (wm) and serial FEV1. Other end-points: Transitional Dyspnoea Index (TDI), health outcomes (St. George's Respiratory Questionnaire [SGRQ]), pharmacokinetics and safety. 246 patients enrolled; 168 completed study. On day 85, UMEC 62.5 and 125 mcg significantly improved LSM change from baseline in trough FEV1 (127 and 152 mL, respectively; p<0.001) compared with placebo. On day 84, UMEC 62.5 and 125 mcg significantly improved LSM change from baseline in 0–6 h wm (166 and 191 mL, respectively; p<0.001) and serial FEV1 at each time point (p≤0.003). Significant improvement in LSM TDI focal score (1.0 and 1.3 units, respectively; p≤0.05) and change from baseline SGRQ total score (−7.9 and −10.87 units, respectively; p<0.001) were noted compared with placebo at week 12. The incidence of adverse events was low and similar across treatments. UMEC 62.5 and 125 mcg significantly improved lung function, dyspnoea and health status compared with placebo and were well tolerated in COPD patients over 12 weeks.