Feldman, Gregory J.Sousa, Ana R.Lipson, David A.Tombs, LeeBarnes, NeilRiley, John H.Patel, SadhanaNaya, IanCompton, ChrisAlcazar Navarrete, Bernardino2023-02-122023-02-122017-11-010741-238Xhttp://hdl.handle.net/10668/18661We report the results of the first direct comparison of the once-daily fixed-dose long-acting muscarinic antagonist/long-acting beta(2)-agonist (LAMA/LABA) combinations umeclidinium/vilanterol (UMEC/VI) and tiotropium/olodaterol (TIO/OLO) in patients with COPD.This was a randomized, two-period crossover open-label study in symptomatic patients with COPD [age 40 years or older, postbronchodilator forced expiratory volume in 1 s (FEV1) of 70% or less and 50% or more of predicted normal values, and modified Medical Research Council Dyspnoea Scale score of 2 or greater] not receiving inhaled corticosteroid therapy. Patients were randomized to receive UMEC/VI (62.5/25 A mu g once daily) via a multidose dry powder inhaler (ELLIPTA) followed by TIO/OLO (5/5 A mu g once daily) via a soft mist inhaler (Respimat), each for 8 weeks with an interim 3-week washout or vice versa. The primary end point was the change from baseline in trough FEV1 at week 8 with a noninferiority margin of - 50 mL in the per-protocol (PP) population. The incidence of adverse events was also assessed.In total, 236 patients (mean age 64.4 years, 60% male) were included in the intent-to-treat population and 227 were included in the PP population. UMEC/VI treatment was noninferior in the PP population and superior in the intent-to-treat population to TIO/OLO treatment with regard to trough FEV1 at week 8 [FEV1 change from baseline 180 mL vs 128 mL; difference 52 mL (95% confidence interval 28-77 mL); penAttribution-NonCommercial 4.0 Internationalhttp://creativecommons.org/licenses/by-nc/4.0/BronchodilationCOPDLAMALABALong-acting muscarinic antagonistLong-acting beta 2-agonistOlodaterolTiotropiumUmeclidiniumVilanterolDynamic hyperinflationDouble-blindCopdTiotropiumSafetyBronchodilatorsCombinationModerateresearch articleopen access10.1007/s12325-017-0626-41865-8652https://link.springer.com/content/pdf/10.1007/s12325-017-0626-4.pdf416262300010