Tags

Type your tag names separated by a space and hit enter

The effect of umeclidinium added to inhaled corticosteroid/long-acting β2-agonist in patients with symptomatic COPD: a randomised, double-blind, parallel-group study.
NPJ Prim Care Respir Med 2016; 26:16031NP

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<0.001). Change from baseline for UMEC+ICS/LABA versus PBO+ICS/LABA was significantly different for CAT score at Day 84 (-1.31, P<0.05), but not for TDI score (0.40, P=0.152). AE incidence was similar with UMEC+ICS/LABA (38%) and PBO+ICS/LABA (42%). UMEC+ICS/LABA improved lung function and CAT score in patients with symptomatic COPD versus PBO+ICS/LABA (ClinicalTrials.gov NCT02257372).

Authors+Show Affiliations

GSK, Stockley Park, Uxbridge, Middlesex, UK.GSK, Stockley Park, Uxbridge, Middlesex, UK.GSK, Research Triangle Park, Durham, NC, USA.GSK, Clinical Statistics (Respiratory), Stockley Park, Uxbridge, Middlesex, UK.GSK, Stockley Park, Uxbridge, Middlesex, UK.GSK, Stockley Park, Uxbridge, Middlesex, UK.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

27334739

Citation

Sousa, Ana R., et al. "The Effect of Umeclidinium Added to Inhaled Corticosteroid/long-acting Β2-agonist in Patients With Symptomatic COPD: a Randomised, Double-blind, Parallel-group Study." NPJ Primary Care Respiratory Medicine, vol. 26, 2016, p. 16031.
Sousa AR, Riley JH, Church A, et al. The effect of umeclidinium added to inhaled corticosteroid/long-acting β2-agonist in patients with symptomatic COPD: a randomised, double-blind, parallel-group study. NPJ Prim Care Respir Med. 2016;26:16031.
Sousa, A. R., Riley, J. H., Church, A., Zhu, C. Q., Punekar, Y. S., & Fahy, W. A. (2016). The effect of umeclidinium added to inhaled corticosteroid/long-acting β2-agonist in patients with symptomatic COPD: a randomised, double-blind, parallel-group study. NPJ Primary Care Respiratory Medicine, 26, p. 16031. doi:10.1038/npjpcrm.2016.31.
Sousa AR, et al. The Effect of Umeclidinium Added to Inhaled Corticosteroid/long-acting Β2-agonist in Patients With Symptomatic COPD: a Randomised, Double-blind, Parallel-group Study. NPJ Prim Care Respir Med. 2016 06 23;26:16031. PubMed PMID: 27334739.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The effect of umeclidinium added to inhaled corticosteroid/long-acting β2-agonist in patients with symptomatic COPD: a randomised, double-blind, parallel-group study. AU - Sousa,Ana R, AU - Riley,John H, AU - Church,Alison, AU - Zhu,Chang-Qing, AU - Punekar,Yogesh S, AU - Fahy,William A, Y1 - 2016/06/23/ PY - 2015/12/11/received PY - 2016/03/31/revised PY - 2016/04/27/accepted PY - 2016/6/24/entrez PY - 2016/6/24/pubmed PY - 2017/12/21/medline SP - 16031 EP - 16031 JF - NPJ primary care respiratory medicine JO - NPJ Prim Care Respir Med VL - 26 N2 - 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<0.001). Change from baseline for UMEC+ICS/LABA versus PBO+ICS/LABA was significantly different for CAT score at Day 84 (-1.31, P<0.05), but not for TDI score (0.40, P=0.152). AE incidence was similar with UMEC+ICS/LABA (38%) and PBO+ICS/LABA (42%). UMEC+ICS/LABA improved lung function and CAT score in patients with symptomatic COPD versus PBO+ICS/LABA (ClinicalTrials.gov NCT02257372). SN - 2055-1010 UR - https://www.unboundmedicine.com/medline/citation/27334739/The_effect_of_umeclidinium_added_to_inhaled_corticosteroid/long_acting_β2_agonist_in_patients_with_symptomatic_COPD:_a_randomised_double_blind_parallel_group_study_ L2 - http://dx.doi.org/10.1038/npjpcrm.2016.31 DB - PRIME DP - Unbound Medicine ER -