RT Journal Article
T1 Comparative Efficacy of Once-Daily Umeclidinium/Vilanterol and Tiotropium/Olodaterol Therapy in Symptomatic Chronic Obstructive Pulmonary Disease: A Randomized Study
A1 Feldman, Gregory J.
A1 Sousa, Ana R.
A1 Lipson, David A.
A1 Tombs, Lee
A1 Barnes, Neil
A1 Riley, John H.
A1 Patel, Sadhana
A1 Naya, Ian
A1 Compton, Chris
A1 Alcazar Navarrete, Bernardino
K1 Bronchodilation
K1 COPD
K1 LAMA
K1 LABA
K1 Long-acting muscarinic antagonist
K1 Long-acting beta 2-agonist
K1 Olodaterol
K1 Tiotropium
K1 Umeclidinium
K1 Vilanterol
K1 Dynamic hyperinflation
K1 Double-blind
K1 Copd
K1 Tiotropium
K1 Safety
K1 Bronchodilators
K1 Combination
K1 Moderate
AB We 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); p
PB Springer
SN 0741-238X
YR 2017
FD 2017-11-01
LK http://hdl.handle.net/10668/18661
UL http://hdl.handle.net/10668/18661
LA en
DS RISalud
RD Apr 11, 2025