Evidence map›Paper›PMID 33976543›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease

Treatment of COPD with Long-Acting Bronchodilators: Association Between Early and Longer-Term Clinically Important Improvement.

Claus F Vogelmeier, Ian P Naya, François Maltais, Leif Bjermer, Edward M Kerwin, Lee Tombs, Paul W Jones, Chris Compton, David A Lipson, Isabelle H Boucot

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in International journal of chronic obstructive pulmonary disease. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.5field-weighted citation impact, top 17% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 11 citations in OpenAlex.

  1. Article
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  4. Article
  5. Review
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

10 authors at 5 institutions in 4 countries.

Claus F VogelmeierDepartment of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-Universität Marburg, Member of the German Center for Lung Research (DZL), Marburg, Germany.
Ian P NayaGlobal Specialty & Primary Care, GSK, Brentford, Middlesex, UK.
François MaltaisCentre De Pneumologie, Institut Universitaire De Cardiologie Et De Pneumologie De Québec, Université Laval, Québec, Canada.ORCID 0000-0002-6809-4651
Leif BjermerRespiratory Medicine and Allergology, Lund University, Lund, Sweden.ORCID 0000-0002-3441-8099
Edward M KerwinAltitude Clinical Consulting and Clinical Research Institute of Southern Oregon, Medford, OR, USA.ORCID 0000-0002-1697-9036
Lee TombsPrecise Approach Ltd, Contingent Worker on Assignment at GSK, Brentford, Middlesex, UK.
Paul W JonesGlobal Specialty & Primary Care, GSK, Brentford, Middlesex, UK.ORCID 0000-0001-6087-9182
Chris ComptonGlobal Specialty & Primary Care, GSK, Brentford, Middlesex, UK.
David A LipsonRespiratory Clinical Sciences, GSK, Collegeville, PA, USA.ORCID 0000-0001-6732-4593
Isabelle H BoucotGlobal Specialty & Primary Care, GSK, Brentford, Middlesex, UK.ORCID 0000-0003-0410-4969
Clinical Research Institute · USGlaxoSmithKline (United States) · USInstitut universitaire de cardiologie et de pneumologie de Québec · CALund University · SEPhilipps University of Marburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis post hoc analysis of the "Early MAXimization of bronchodilation for improving COPD stability" (EMAX) trial investigated whether patients achieving early clinically important improvement (CII) sustained longer-term improvements and lower risk of clinically important deterioration (CID).

methodsPatients were randomized to umeclidinium/vilanterol, umeclidinium, or salmeterol for 24 weeks. The patient-reported outcomes (PROs) Transition Dyspnea Index (TDI), Evaluating Respiratory Symptoms, St George's Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT) were assessed. CII, defined as attaining minimum clinically important differences (MCID) in ≥2 PROs, was assessed at Weeks 4, 12 and 24. CID was defined as a deterioration in CAT, SGRQ, TDI by the MCID and/or a moderate/severe exacerbation from Day 30.

resultsOf 2425 patients, 50%, 53% and 51% achieved a CII at Weeks 4, 12 and 24, respectively. Patients with a CII at Week 4 versus those without had significantly greater odds of achieving a CII at Weeks 12 and 24 (odds ratio: 5.57 [95% CI: 4.66, 6.66]; 4.09 [95% CI: 3.44, 4.86]). The risk of a CID was higher in patients who did not achieve a CII at Week 4 compared with patients who did (hazard ratio [95% CI]: 2.09 [1.86, 2.34]). Patients treated with umeclidinium/vilanterol versus either monotherapy had significantly greater odds of achieving CII at Weeks 4, 12 and 24.

conclusionAchieving a CII at Week 4 was associated with longer-term improvement in PROs and a reduced risk of deterioration. Further research is required to investigate the importance of an early response to treatment on the long-term disease course.

Indexed as

Bronchodilator AgentsPulmonary Disease, Chronic ObstructiveForced Expiratory VolumeHumansSalmeterol XinafoateTreatment OutcomeBronchodilator AgentsSalmeterol Xinafoatebronchodilatorclinically important deteriorationclinically important improvementCOPD symptomsearly improvementpatient-reported outcomes

Identifiers

PMID33976543
PMCPMC8106450
OpenAlexW3158003901

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.