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The effect of umeclidinium added to inhaled corticosteroid/long-acting β2-agonist in patients with symptomatic COPD: a randomised, double-blind, parallel-group study
- Source :
- NPJ Primary Care Respiratory Medicine
- Publication Year :
- 2015
-
Abstract
- Benefits of triple therapy with a long-acting muscarinic antagonist (LAMA), added to inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA), have been demonstrated. Limited data assessing the efficacy of the LAMA umeclidinium (UMEC) added to ICS/LABA are available. The aim of this study is to evaluate the efficacy and safety of UMEC added to ICS/LABAs in patients with moderate-to-very-severe COPD. This is a multicentre, randomised, double-blind, parallel-group study. Patients were symptomatic (modified Medical Research Council Dyspnoea Scale score ⩾2), despite receiving ICS/LABA (fluticasone propionate/salmeterol (FP/SAL, branded) 500/50 mcg, budesonide/formoterol (BD/FOR, branded) 200/6 mcg or 400/12 mcg, or other ICS/LABAs) ⩾30 days before the run-in (7±2 days). Patients were randomised 1:1 to once-daily UMEC 62.5 mcg or placebo (PBO), added to twice-daily open-label ICS/LABA for 12 weeks. Primary end point was trough forced expiratory volume in 1 s (FEV1) at Day 85; secondary end point was weighted mean (WM) 0–6 h FEV1 at Day 84; other end points included COPD Assessment Test (CAT) score and Transition Dyspnoea Index (TDI) score. Adverse events (AEs) were investigated. In the UMEC+ICS/LABA and PBO+ICS/LABA groups, 119 and 117 patients were randomised, respectively. Patients received FP/SAL (40%), BD/FOR (43%) and other ICS/LABAs (17%). UMEC+ICS/LABA resulted in significant improvements in trough FEV1 (Day 85) and in WM 0–6 h FEV1 (Day 84) versus PBO+ICS/LABA (difference: 123 and 148 ml, respectively, both P
- Subjects :
- Pulmonary and Respiratory Medicine
Budesonide
Male
medicine.medical_specialty
Quinuclidines
Combination therapy
medicine.drug_class
Placebo
Fluticasone propionate
Article
03 medical and health sciences
Pulmonary Disease, Chronic Obstructive
0302 clinical medicine
Double-Blind Method
Adrenal Cortex Hormones
Internal medicine
Bronchodilator
Forced Expiratory Volume
Administration, Inhalation
medicine
Humans
030212 general & internal medicine
Adrenergic beta-2 Receptor Agonists
Aged
COPD
business.industry
Public Health, Environmental and Occupational Health
medicine.disease
Surgery
Bronchodilator Agents
030228 respiratory system
Drug Therapy, Combination
Female
Salmeterol
Formoterol
business
hormones, hormone substitutes, and hormone antagonists
medicine.drug
Subjects
Details
- ISSN :
- 20551010
- Volume :
- 26
- Database :
- OpenAIRE
- Journal :
- NPJ primary care respiratory medicine
- Accession number :
- edsair.doi.dedup.....0f00bebfbe23933148bccd80ec8d512f