Efficacy of umeclidinium/vilanterol versus umeclidinium and salmeterol monotherapies in symptomatic patients with COPD not receiving inhaled corticosteroids: the EMAX randomised trial.


Journal

Respiratory research
ISSN: 1465-993X
Titre abrégé: Respir Res
Pays: England
ID NLM: 101090633

Informations de publication

Date de publication:
30 Oct 2019
Historique:
received: 26 06 2019
accepted: 20 09 2019
entrez: 1 11 2019
pubmed: 2 11 2019
medline: 24 4 2020
Statut: epublish

Résumé

Prospective evidence is lacking regarding incremental benefits of long-acting dual- versus mono-bronchodilation in improving symptoms and preventing short-term disease worsening/treatment failure in low exacerbation risk patients with chronic obstructive pulmonary disease (COPD) not receiving inhaled corticosteroids. The 24-week, double-blind, double-dummy, parallel-group Early MAXimisation of bronchodilation for improving COPD stability (EMAX) trial randomised patients at low exacerbation risk not receiving inhaled corticosteroids, to umeclidinium/vilanterol 62.5/25 μg once-daily, umeclidinium 62.5 μg once-daily or salmeterol 50 μg twice-daily. The primary endpoint was trough forced expiratory volume in 1 s (FEV Change from baseline in trough FEV Umeclidinium/vilanterol consistently provides early and sustained improvements in lung function and symptoms and reduces the risk of deterioration/treatment failure versus umeclidinium or salmeterol in symptomatic patients with low exacerbation risk not receiving inhaled corticosteroids. These findings suggest a potential for early use of dual bronchodilators to help optimise therapy in this patient group.

Sections du résumé

BACKGROUND BACKGROUND
Prospective evidence is lacking regarding incremental benefits of long-acting dual- versus mono-bronchodilation in improving symptoms and preventing short-term disease worsening/treatment failure in low exacerbation risk patients with chronic obstructive pulmonary disease (COPD) not receiving inhaled corticosteroids.
METHODS METHODS
The 24-week, double-blind, double-dummy, parallel-group Early MAXimisation of bronchodilation for improving COPD stability (EMAX) trial randomised patients at low exacerbation risk not receiving inhaled corticosteroids, to umeclidinium/vilanterol 62.5/25 μg once-daily, umeclidinium 62.5 μg once-daily or salmeterol 50 μg twice-daily. The primary endpoint was trough forced expiratory volume in 1 s (FEV
RESULTS RESULTS
Change from baseline in trough FEV
CONCLUSIONS CONCLUSIONS
Umeclidinium/vilanterol consistently provides early and sustained improvements in lung function and symptoms and reduces the risk of deterioration/treatment failure versus umeclidinium or salmeterol in symptomatic patients with low exacerbation risk not receiving inhaled corticosteroids. These findings suggest a potential for early use of dual bronchodilators to help optimise therapy in this patient group.

Identifiants

pubmed: 31666084
doi: 10.1186/s12931-019-1193-9
pii: 10.1186/s12931-019-1193-9
pmc: PMC6821007
doi:

Substances chimiques

Adrenal Cortex Hormones 0
Benzyl Alcohols 0
Bronchodilator Agents 0
Chlorobenzenes 0
GSK573719 0
Quinuclidines 0
vilanterol 028LZY775B
Salmeterol Xinafoate 6EW8Q962A5

Types de publication

Comparative Study Journal Article Multicenter Study Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

238

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Auteurs

François Maltais (F)

Centre de Pneumologie, Institut universitaire de cardiologie et de pneumologie de Québec, Université Laval, Québec, Canada. Francois.Maltais@fmed.ulaval.ca.

Leif Bjermer (L)

Respiratory Medicine and Allergology, Lund University, Lund, Sweden.

Edward M Kerwin (EM)

Clinical Research Institute of Southern Oregon, Medford, OR, USA.

Paul W Jones (PW)

Global Specialty & Primary Care, GSK, Brentford, Middlesex, UK.

Michael L Watkins (ML)

Respiratory Research and Development, GSK, Research Triangle Park, NC, USA.

Lee Tombs (L)

Precise Approach Ltd, contingent worker on assignment at GSK, Stockley Park West, Uxbridge, Middlesex, UK.

Ian P Naya (IP)

Global Specialty & Primary Care, GSK, Brentford, Middlesex, UK.

Isabelle H Boucot (IH)

Global Specialty & Primary Care, GSK, Brentford, Middlesex, UK.

David A Lipson (DA)

Respiratory Research and Development, GSK, Collegeville, PA, USA.
Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.

Chris Compton (C)

Global Specialty & Primary Care, GSK, Brentford, Middlesex, UK.

Mitra Vahdati-Bolouri (M)

Respiratory Discovery Medicine, Respiratory Research and Development, GSK, Stevenage, Hertfordshire, UK.

Claus F Vogelmeier (CF)

Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-Universität Marburg, Germany, Member of the German Center for Lung Research (DZL), Marburg, Germany.

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Classifications MeSH