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Improvements in lung function with umeclidinium/vilanterol versus fluticasone propionate/salmeterol in patients with moderate-to-severe COPD and infrequent exacerbations.
Respir Med 2015; 109(7):870-81RM

Abstract

BACKGROUND

Umeclidinium (UMEC; long-acting muscarinic antagonist [LAMA])/vilanterol (VI; long-acting beta2-agonist [LABA]) and fluticasone propionate/salmeterol (FP/SAL) (inhaled corticosteroid/LABA) are approved maintenance therapies for chronic obstructive pulmonary disease (COPD). Two studies compared efficacy and safety of UMEC/VI with FP/SAL in patients with moderate-to-severe COPD with no exacerbations in the previous year.

METHODS

In these 12-week, multicenter, double-blind, parallel-group, double-dummy trials, randomized (1:1) patients received once-daily UMEC/VI 62.5/25 mcg or twice-daily FP/SAL 250/50 mcg (DB2114930 n = 353 and 353; DB2114951 n = 349 and 348, respectively; intent-to-treat). 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, dyspnea, quality of life (QoL) and safety.

RESULTS

UMEC/VI demonstrated statistically significant, clinically meaningful improvements in lung function measures versus FP/SAL. For 0-24 h wmFEV1 (Day 84), improvements with UMEC/VI versus FP/SAL were 74 mL (95% confidence interval [CI]: 38-110; DB2114930) and 101 mL (63-139; DB2114951) (both p < 0.001). Trough FEV1 improvements were 82 mL (45-119) and 98 mL (59-137) (both p < 0.001) for UMEC/VI versus FP/SAL, respectively. Both treatments demonstrated similar, clinically meaningful improvements from baseline in dyspnea (Transition Dyspnea Index focal score >1 unit) and QoL (St George's Respiratory Questionnaire Total score >4-unit decrease) in both studies with no statistical differences between treatments. Adverse event rates were similar: 26 and 30% UMEC/VI; 27 and 31% FP/SAL.

CONCLUSIONS

Once-daily UMEC/VI 62.5/25 mcg over 12 weeks resulted in statistically significant, clinically meaningful improvements in lung function versus twice-daily FP/SAL 250/50 mcg in patients with moderate-to-severe COPD with infrequent exacerbations. Both treatments improved dyspnea and QoL.

CLINICAL TRIAL REGISTRATION

DB2114930/NCT01817764; DB2114951/NCT01879410.

Authors+Show Affiliations

Department of Medicine, University of North Carolina College of Medicine, Chapel Hill, NC 27599, USA. Electronic address: james_donohue@med.unc.edu.The Respiratory Medicines Development Centre, Stockley Park West, 1-3 Ironbridge Road, Uxbridge, Middlesex UB11 1BT, UK. Electronic address: sally.d.worsley@gsk.com.The Quantitative Sciences Division, GSK, Stockley Park West, 1-3 Ironbridge Road, Uxbridge, Middlesex UB11 1BT, UK. Electronic address: chang-qing.2.zhu@gsk.com.Global Clinical Safety and Pharmacovigilance, GSK, Stockley Park West, 1-3 Ironbridge Road, Uxbridge, Middlesex UB11 1BT, UK. Electronic address: liz.x.hardaker@gsk.com.The Respiratory Medicines Development Center, GSK, 5 Moore Drive, PO Box 13398, Research Triangle Park, NC 27709-3398, USA. Electronic address: alison.x.church@gsk.com.

Pub Type(s)

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

Language

eng

PubMed ID

26006754

Citation

Donohue, James F., et al. "Improvements in Lung Function With Umeclidinium/vilanterol Versus Fluticasone Propionate/salmeterol in Patients With Moderate-to-severe COPD and Infrequent Exacerbations." Respiratory Medicine, vol. 109, no. 7, 2015, pp. 870-81.
Donohue JF, Worsley S, Zhu CQ, et al. Improvements in lung function with umeclidinium/vilanterol versus fluticasone propionate/salmeterol in patients with moderate-to-severe COPD and infrequent exacerbations. Respir Med. 2015;109(7):870-81.
Donohue, J. F., Worsley, S., Zhu, C. Q., Hardaker, L., & Church, A. (2015). Improvements in lung function with umeclidinium/vilanterol versus fluticasone propionate/salmeterol in patients with moderate-to-severe COPD and infrequent exacerbations. Respiratory Medicine, 109(7), pp. 870-81. doi:10.1016/j.rmed.2015.04.018.
Donohue JF, et al. Improvements in Lung Function With Umeclidinium/vilanterol Versus Fluticasone Propionate/salmeterol in Patients With Moderate-to-severe COPD and Infrequent Exacerbations. Respir Med. 2015;109(7):870-81. PubMed PMID: 26006754.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Improvements in lung function with umeclidinium/vilanterol versus fluticasone propionate/salmeterol in patients with moderate-to-severe COPD and infrequent exacerbations. AU - Donohue,James F, AU - Worsley,Sally, AU - Zhu,Chang-Qing, AU - Hardaker,Liz, AU - Church,Alison, Y1 - 2015/05/08/ PY - 2014/12/17/received PY - 2015/04/17/revised PY - 2015/04/27/accepted PY - 2015/5/27/entrez PY - 2015/5/27/pubmed PY - 2016/3/10/medline KW - COPD KW - Fluticasone propionate KW - Salmeterol KW - Umeclidinium KW - Vilanterol SP - 870 EP - 81 JF - Respiratory medicine JO - Respir Med VL - 109 IS - 7 N2 - BACKGROUND: Umeclidinium (UMEC; long-acting muscarinic antagonist [LAMA])/vilanterol (VI; long-acting beta2-agonist [LABA]) and fluticasone propionate/salmeterol (FP/SAL) (inhaled corticosteroid/LABA) are approved maintenance therapies for chronic obstructive pulmonary disease (COPD). Two studies compared efficacy and safety of UMEC/VI with FP/SAL in patients with moderate-to-severe COPD with no exacerbations in the previous year. METHODS: In these 12-week, multicenter, double-blind, parallel-group, double-dummy trials, randomized (1:1) patients received once-daily UMEC/VI 62.5/25 mcg or twice-daily FP/SAL 250/50 mcg (DB2114930 n = 353 and 353; DB2114951 n = 349 and 348, respectively; intent-to-treat). 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, dyspnea, quality of life (QoL) and safety. RESULTS: UMEC/VI demonstrated statistically significant, clinically meaningful improvements in lung function measures versus FP/SAL. For 0-24 h wmFEV1 (Day 84), improvements with UMEC/VI versus FP/SAL were 74 mL (95% confidence interval [CI]: 38-110; DB2114930) and 101 mL (63-139; DB2114951) (both p < 0.001). Trough FEV1 improvements were 82 mL (45-119) and 98 mL (59-137) (both p < 0.001) for UMEC/VI versus FP/SAL, respectively. Both treatments demonstrated similar, clinically meaningful improvements from baseline in dyspnea (Transition Dyspnea Index focal score >1 unit) and QoL (St George's Respiratory Questionnaire Total score >4-unit decrease) in both studies with no statistical differences between treatments. Adverse event rates were similar: 26 and 30% UMEC/VI; 27 and 31% FP/SAL. CONCLUSIONS: Once-daily UMEC/VI 62.5/25 mcg over 12 weeks resulted in statistically significant, clinically meaningful improvements in lung function versus twice-daily FP/SAL 250/50 mcg in patients with moderate-to-severe COPD with infrequent exacerbations. Both treatments improved dyspnea and QoL. CLINICAL TRIAL REGISTRATION: DB2114930/NCT01817764; DB2114951/NCT01879410. SN - 1532-3064 UR - https://www.unboundmedicine.com/medline/citation/26006754/Improvements_in_lung_function_with_umeclidinium/vilanterol_versus_fluticasone_propionate/salmeterol_in_patients_with_moderate_to_severe_COPD_and_infrequent_exacerbations_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0954-6111(15)00152-3 DB - PRIME DP - Unbound Medicine ER -