Defining Patient-Reported Outcomes in Chronic Obstructive Pulmonary Disease

2012 ◽  
Vol 96 (4) ◽  
pp. 767-787 ◽  
Author(s):  
Jonathan P. Singer ◽  
Roger D. Yusen
Keyword(s):  
Chronic Obstructive Pulmonary Disease ◽  
Pulmonary Disease ◽  
Patient Reported Outcomes ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Patient Reported

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

2016 ◽  
Vol 2 (2) ◽  
pp. 00101-2015 ◽  
Author(s):  
Tara Rheault ◽  
Sanjeev Khindri ◽  
Mitra Vahdati-Bolouri ◽  
Alison Church ◽  
William A. Fahy
Keyword(s):  
Chronic Obstructive Pulmonary Disease ◽  
Pulmonary Disease ◽  
Patient Reported Outcomes ◽  
Chronic Obstructive ◽  
Open Label ◽  
Obstructive Pulmonary Disease ◽  
Once Daily ◽  
Inferior Margin ◽  
Link Type ◽  
Patient Reported

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.

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