RT Journal Article
SR Electronic
T1 A randomised, open-label study of umeclidinium <em>versus</em> glycopyrronium in patients with COPD
JF ERJ Open Research
JO erjor
FD European Respiratory Society
SP 00101-2015
DO 10.1183/23120541.00101-2015
VO 2
IS 2
A1 Tara Rheault
A1 Sanjeev Khindri
A1 Mitra Vahdati-Bolouri
A1 Alison Church
A1 William A. Fahy
YR 2016
UL http://openres.ersjournals.com/content/2/2/00101-2015.abstract
AB This study compared the efficacy and safety of once-daily umeclidinium 62.5 µg with once-daily glycopyrronium 50 µg in patients with moderate-to-severe chronic obstructive pulmonary disease.This was a 12-week, multicentre, randomised, open-label, parallel-group study (Clinicaltrials.gov: NCT02236611). Patients were randomised 1:1 to umeclidinium 62.5 µg or glycopyrronium 50 µg administered via Ellipta or Breezhaler dry powder inhaler, respectively. The primary endpoint was trough forced expiratory volume in 1 s (FEV1) at day 85 in the per-protocol population. Other endpoints included: weighted mean FEV1 over 0–24 h and patient-reported outcomes (transition dyspnoea index score and St George's Respiratory Questionnaire total score). Adverse events were also assessed.A total of 1037 patients were randomised to treatment. Umeclidinium was non-inferior (margin: −50 mL) to glycopyrronium (trough FEV1 at day 85 treatment difference: 24 mL, 95% confidence intervals: −5–54). Improvements in other endpoints were similar between treatments. Adverse event incidences were similar for umeclidinium (37%) and glycopyrronium (36%).Once-daily umeclidinium was non-inferior to once-daily glycopyrronium in patients with chronic obstructive pulmonary disease in trough FEV1 at day 85. Patient-reported outcomes and safety profiles were similar for both treatments.Once-daily umeclidinium is non-inferior to once-daily glycopyrronium in patients with COPD by trough FEV1 at day 85 http://ow.ly/4mRdE6