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Gregory Feldman,1 François Maltais,2 Sanjeev Khindri,3 Mitra Vahdati-Bolouri,3 Alison Church,4 William A Fahy,3 Roopa Trivedi4,5 1S. Carolina Pharmaceutical Research, Spartanburg, SC, USA; 2Institut universitaire de cardiologie et de pneumologie de Québec, Quebec, QC, Canada; 3GSK, Respiratory Research and Development, Middlesex, UK; 4GSK, Respiratory and Immuno-Inflammation Research, Triangle Park, NC, USA; 5Pearl Therapeutics Inc., Durham, NC, USA Background: The long-acting muscarinic antagonists umeclidinium (UMEC) and tiotropium (TIO) are approved once-daily maintenance therapies for COPD. This study investigated the efficacy and safety of UMEC versus TIO in COPD. Methods: This was a 12-week, multicenter, randomized, blinded, double-dummy, parallel-group, non-inferiority study. Patients were randomized 1:1 to UMEC 62.5 µg plus placebo or TIO 18 µg plus placebo. The primary end point was trough forced expiratory volume in 1 second (FEV1) at day 85 (non-inferiority margin -50 mL; per-protocol [PP] population). Other end points included weighted mean FEV1 over 0–24 and 12–24 hours post-dose. Patient-reported outcomes comprised Transition Dyspnea Index score, St George’s Respiratory Questionnaire total score, and COPD Assessment Test score. Adverse events were also assessed. Results: In total, 1,017 patients were randomized to treatment. In the PP population, 489 and 487 patients received UMEC and TIO, respectively. In the PP population, change from baseline in trough FEV1 was greater with UMEC versus TIO at day 85, meeting non-inferiority and superiority margins (difference: 59 mL; 95% confidence interval [CI]: 29–88; P |
