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A randomised, open-label study of umeclidinium versus glycopyrronium in patients with COPD.


ABSTRACT: 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.

SUBMITTER: Rheault T 

PROVIDER: S-EPMC5005182 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature

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A randomised, open-label study of umeclidinium <i>versus</i> glycopyrronium in patients with COPD.

Rheault Tara T   Khindri Sanjeev S   Vahdati-Bolouri Mitra M   Church Alison A   Fahy William A WA  

ERJ open research 20160427 2


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 <i>via</i> Ellipta or Breezhaler dry powder inhaler, respectively. The primary endpoint was trough forced  ...[more]

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