Once-Daily Umeclidinium/Vilanterol 125/25 μg Therapy in COPD A Randomized, Controlled Study

Background: Combination long-acting bronchodilator therapy may be more effective than long acting bronchodilator monotherapy in COPD. Our objectives were to compare the efficacy and safety of once-daily umeclidinium bromide (UMEC)/vilanterol (VI) 125/25 mu g with placebo and UMEC or VI monotherapy in COPD. Methods: This was a double-blind, placebo-controlled, parallel-group study. A total of 1,493 patients were randomized (3: 3: 3: 2) to 24 weeks of treatment with UMEC/VI 125/25 mu g, UMEC 125 m g, VI 25 mu g, or placebo once daily via dry powder inhaler. Results: Primary efficacy end point was trough FEV 1 on day 169 (23-24 h postdose). Additional lung-function, symptomatic, and health-related quality-of-life end points were also assessed. Safety evaluations included adverse events, vital signs, ECG, and clinical laboratory measurements. All active treatments significantly improved trough FEV 1 vs placebo (0.124-0.238 L, all P<.001). Improvements with UMEC/VI 125/25 m g were significantly greater than for UMEC 125 m g or VI 25 m g (0.079 L and 0.114 L, both P <=.001). Improvements for UMEC/VI 125/25 m g vs placebo were observed for the Transition Dyspnea Index (1.0 unit, P<.001), rescue albuterol use at weeks 1 to 24 (-1.5 puffs/d), and St. George's Respiratory Questionnaire (-3.60 units, P<.001). No safety signals were observed. Conclusions: Once-daily UMEC/VI 125/25 mu g was well tolerated and provided greater improvements in lung function, health status, and dyspnea scores compared with monotherapy components and placebo over 24 weeks. This study supports the use of UMEC/VI 125/25 mu g for the maintenance treatment of COPD.