Umeclidinium in patients with COPD: a randomised, placebo-controlled study.
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Trivedi R, Richard N, Mehta R, Church A
Umeclidinium in patients with COPD: a randomised, placebo-controlled study.
Eur Respir J. 2014 Jan;43(1):72-81. doi: 10.1183/09031936.00033213. Epub 2013 Aug 15.
- PubMed ID
- 23949963 [ View in PubMed]
- Abstract
Efficacy and safety of umeclidinium administered in a dry power inhaler were evaluated in moderate-to-very-severe chronic obstructive pulmonary disease patients. This was a randomised, placebo-controlled study assessing once-daily umeclidinium 62.5 and 125 mug over 12 weeks. The primary end-point was change from baseline in trough forced expiratory volume in 1 s (FEV1) on day 85. Secondary end-points were 0-6-h weighted mean and serial forced expiratory volume in 1 s. Other end-points were transitional dyspnoea index, health outcomes (St George's Respiratory Questionnaire), pharmacokinetics and safety. 246 patients were enrolled; 168 completed the study. On day 85, umeclidinium 62.5 and 125 mug significantly improved least squares mean change from baseline in trough FEV1 (127 and 152 mL, respectively; p<0.001) compared with placebo. On day 84, umeclidinium 62.5 and 125 mug significantly improved least squares mean change from baseline in 0-6-h weighted mean (166 and 191 mL, respectively; p<0.001) and serial FEV1 at each time point (p