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Umeclidinium/vilanterol versus fluticasone propionate/salmeterol in COPD: a randomised trial.
BMC Pulm Med 2015; 15:91BP

Abstract

BACKGROUND

Umeclidinium (UMEC; long-acting muscarinic antagonist) plus vilanterol (VI; long-acting beta2 agonist [LABA]) and the LABA/inhaled corticosteroid fluticasone propionate/salmeterol (FP/SAL) are approved maintenance treatments for chronic obstructive pulmonary disease (COPD). This 12-week, multicentre, double-blind, parallel-group, double-dummy study compared the efficacy and safety of these treatments in symptomatic patients with moderate-to-severe COPD with no exacerbations in the year prior to enrolment.

METHODS

Patients (n = 717) were randomised 1:1 to once-daily UMEC/VI 62.5/25 mcg or twice-daily FP/SAL 500/50 mcg. Endpoints included 0-24 h weighted mean (wm) forced expiratory volume in 1 s (FEV1) (Day 84; primary), trough FEV1 (Day 85; secondary), other lung function endpoints, symptoms, quality of life (QoL) and safety.

RESULTS

Improvements with UMEC/VI versus FP/SAL were 0.080 L (95 % confidence interval: 0.046-0.113; wmFEV1) and 0.090 L (0.055-0.125; trough FEV1) (both p < 0.001). UMEC/VI statistically significantly improved all other lung function measures versus FP/SAL. Both treatments demonstrated a clinically meaningful improvement in symptoms (Transition Dyspnoea Index ≥1 unit) and QoL (St George's Respiratory Questionnaire Total score ≥4 unit decrease from baseline) over 12 weeks. The incidence of adverse events was 28 % (UMEC/VI) and 29 % (FP/SAL); nasopharyngitis and headache were most common.

CONCLUSIONS

Once-daily UMEC/VI 62.5/25 mcg over 12 weeks resulted in significant and sustained improvements in lung function versus twice-daily FP/SAL 500/50 mcg in patients with moderate-to-severe COPD and with no exacerbations in the year prior to enrolment.

TRIAL REGISTRATION

NCT01822899 Registration date: March 28, 2013.

Authors+Show Affiliations

University of Manchester, Medicines Evaluation Unit, Langley Building, University Hospital of South Manchester Foundations Trust, Southmoor Road, Manchester, M23 9QZ, UK. dsingh@meu.org.uk.Respiratory Medicines Development Centre, GSK, London, UK. sally.d.worsley@gsk.com.Quantitative Sciences Division, GSK, London, UK. chang-qing.2.zhu@gsk.com.Global Clinical Safety and Pharmacovigilance, GSK, London, UK. liz.x.hardaker@gsk.com.Respiratory Medicines Development Center, GSK, Research Triangle Park, North Carolina, USA. alison.x.church@gsk.com.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26286141

Citation

Singh, Dave, et al. "Umeclidinium/vilanterol Versus Fluticasone Propionate/salmeterol in COPD: a Randomised Trial." BMC Pulmonary Medicine, vol. 15, 2015, p. 91.
Singh D, Worsley S, Zhu CQ, et al. Umeclidinium/vilanterol versus fluticasone propionate/salmeterol in COPD: a randomised trial. BMC Pulm Med. 2015;15:91.
Singh, D., Worsley, S., Zhu, C. Q., Hardaker, L., & Church, A. (2015). Umeclidinium/vilanterol versus fluticasone propionate/salmeterol in COPD: a randomised trial. BMC Pulmonary Medicine, 15, p. 91. doi:10.1186/s12890-015-0092-1.
Singh D, et al. Umeclidinium/vilanterol Versus Fluticasone Propionate/salmeterol in COPD: a Randomised Trial. BMC Pulm Med. 2015 Aug 19;15:91. PubMed PMID: 26286141.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Umeclidinium/vilanterol versus fluticasone propionate/salmeterol in COPD: a randomised trial. AU - Singh,Dave, AU - Worsley,Sally, AU - Zhu,Chang-Qing, AU - Hardaker,Liz, AU - Church,Alison, Y1 - 2015/08/19/ PY - 2015/02/03/received PY - 2015/08/04/accepted PY - 2015/8/20/entrez PY - 2015/8/20/pubmed PY - 2016/3/18/medline SP - 91 EP - 91 JF - BMC pulmonary medicine JO - BMC Pulm Med VL - 15 N2 - BACKGROUND: Umeclidinium (UMEC; long-acting muscarinic antagonist) plus vilanterol (VI; long-acting beta2 agonist [LABA]) and the LABA/inhaled corticosteroid fluticasone propionate/salmeterol (FP/SAL) are approved maintenance treatments for chronic obstructive pulmonary disease (COPD). This 12-week, multicentre, double-blind, parallel-group, double-dummy study compared the efficacy and safety of these treatments in symptomatic patients with moderate-to-severe COPD with no exacerbations in the year prior to enrolment. METHODS: Patients (n = 717) were randomised 1:1 to once-daily UMEC/VI 62.5/25 mcg or twice-daily FP/SAL 500/50 mcg. Endpoints included 0-24 h weighted mean (wm) forced expiratory volume in 1 s (FEV1) (Day 84; primary), trough FEV1 (Day 85; secondary), other lung function endpoints, symptoms, quality of life (QoL) and safety. RESULTS: Improvements with UMEC/VI versus FP/SAL were 0.080 L (95 % confidence interval: 0.046-0.113; wmFEV1) and 0.090 L (0.055-0.125; trough FEV1) (both p < 0.001). UMEC/VI statistically significantly improved all other lung function measures versus FP/SAL. Both treatments demonstrated a clinically meaningful improvement in symptoms (Transition Dyspnoea Index ≥1 unit) and QoL (St George's Respiratory Questionnaire Total score ≥4 unit decrease from baseline) over 12 weeks. The incidence of adverse events was 28 % (UMEC/VI) and 29 % (FP/SAL); nasopharyngitis and headache were most common. CONCLUSIONS: Once-daily UMEC/VI 62.5/25 mcg over 12 weeks resulted in significant and sustained improvements in lung function versus twice-daily FP/SAL 500/50 mcg in patients with moderate-to-severe COPD and with no exacerbations in the year prior to enrolment. TRIAL REGISTRATION: NCT01822899 Registration date: March 28, 2013. SN - 1471-2466 UR - https://www.unboundmedicine.com/medline/citation/26286141/Umeclidinium/vilanterol_versus_fluticasone_propionate/salmeterol_in_COPD:_a_randomised_trial_ L2 - https://bmcpulmmed.biomedcentral.com/articles/10.1186/s12890-015-0092-1 DB - PRIME DP - Unbound Medicine ER -