title: A randomised, open-label study of umeclidiniumversusglycopyrronium 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 administeredviaEllipta 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 FEV1over 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 FEV1at 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 FEV1at day 85. Patient-reported outcomes and safety profiles were similar for both treatments.
authors.affiliation: GSK, Respiratory and Immuno-Inflammation, Research Triangle Park, NC, USA.
authors.forename: Tara
authors.initials: T
authors.lastname: Rheault
authors.affiliation: GSK, Respiratory Research and Development, Middlesex, UK.
authors.forename: Sanjeev
authors.initials: S
authors.lastname: Khindri
authors.affiliation: GSK, Respiratory Research and Development, Middlesex, UK.
authors.forename: Mitra
authors.initials: M
authors.lastname: Vahdati-Bolouri
authors.affiliation: GSK, Respiratory and Immuno-Inflammation, Research Triangle Park, NC, USA.
authors.forename: Alison
authors.initials: A
authors.lastname: Church
authors.affiliation: GSK, Respiratory Research and Development, Middlesex, UK.
authors.forename: William A
authors.initials: WA
authors.lastname: Fahy