Evidence map›Paper›PMID 31666084›Full record

Trial reportRespiratory research2019

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

François Maltais, Leif Bjermer, Edward M Kerwin, Paul W Jones, Michael L Watkins, Lee Tombs, Ian P Naya, Isabelle H Boucot, David A Lipson, Chris Compton and 2 more

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Respiratory research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03034915 (A 24-week Treatment, Multi-center, Randomized, Double-blind, Double-dummy, Parallel Group Study to Compare Umeclidinium/Vilanterol, Umeclidinium, and Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease), which is not on this map. Cited by 60 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03034915 phase4completednot on this map

A 24-week Treatment, Multi-center, Randomized, Double-blind, Double-dummy, Parallel Group Study to Compare Umeclidinium/Vilanterol, Umeclidinium, and Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

TypeinterventionalSponsorGlaxoSmithKlineRan2017 to 2018Enrolled2,696ConditionsPulmonary Disease, Chronic ObstructiveArmsUMEC/VI 62.5/25 mcg via ELLIPTA, UMEC 62.5 mcg via ELLIPTA, Salmeterol 50 mcg via DISKUS, Placebo via ELLIPTA, Placebo via DISKUS
3 · Its place in the literature

Who cites it

60 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Race-Based Pulmonary Function Testing Correction in COPD Inhaler Therapy Trials: A Systematic Review.International journal of chronic obstructive pulmonary disease · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

François MaltaisCentre de Pneumologie, Institut universitaire de cardiologie et de pneumologie de Québec, Université Laval, Québec, Canada. Francois.Maltais@fmed.ulaval.ca.
Leif BjermerRespiratory Medicine and Allergology, Lund University, Lund, Sweden.
Edward M KerwinClinical Research Institute of Southern Oregon, Medford, OR, USA.
Paul W JonesGlobal Specialty & Primary Care, GSK, Brentford, Middlesex, UK.
Michael L WatkinsRespiratory Research and Development, GSK, Research Triangle Park, NC, USA.
Lee TombsPrecise Approach Ltd, contingent worker on assignment at GSK, Stockley Park West, Uxbridge, Middlesex, UK.
Ian P NayaGlobal Specialty & Primary Care, GSK, Brentford, Middlesex, UK.
Isabelle H BoucotGlobal Specialty & Primary Care, GSK, Brentford, Middlesex, UK.
David A LipsonRespiratory Research and Development, GSK, Collegeville, PA, USA.
Chris ComptonGlobal Specialty & Primary Care, GSK, Brentford, Middlesex, UK.
Mitra Vahdati-BolouriRespiratory Discovery Medicine, Respiratory Research and Development, GSK, Stevenage, Hertfordshire, UK.
Claus F VogelmeierDepartment 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.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProspective 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.

methodsThe 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

resultsChange from baseline in trough FEV

conclusionsUmeclidinium/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.

Indexed as

Adrenal Cortex HormonesAdministration, InhalationAgedBenzyl AlcoholsBronchodilator AgentsChlorobenzenesDouble-Blind MethodDrug Therapy, CombinationFemaleForced Expiratory VolumeHumansMaleMiddle AgedPulmonary Disease, Chronic ObstructiveQuinuclidinesSalmeterol XinafoateAdrenal Cortex HormonesBenzyl AlcoholsBronchodilator AgentsChlorobenzenesGSK573719QuinuclidinesSalmeterol XinafoatevilanterolBronchodilator therapyClinically important deteriorationCOPDDyspnoeaLung function

Identifiers

PMID31666084
PMCPMC6821007

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.