Evidence map›Paper›PMID 35970518›Full record

Trial reportRespirology (Carlton, Vic.)2022

Effect of chronic mucus hypersecretion on treatment responses to inhaled therapies in patients with chronic obstructive pulmonary disease: Post hoc analysis of the IMPACT trial.

Philip J Thompson, Gerard J Criner, Mark T Dransfield, David M G Halpin, MeiLan K Han, David A Lipson, Ghassan J Maghzal, Fernando J Martinez, Dawn Midwinter, Dave Singh and 2 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Respirology (Carlton, Vic.), 2022. 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
1.2field-weighted citation impact, top 20% 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, 8 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Observational
  5. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 11 institutions in 3 countries.

Philip J ThompsonThe Lung Health Clinic, Nedlands, Western Australia, Australia.ORCID 0000-0002-3472-2939
Gerard J CrinerLewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania, USA.ORCID 0000-0003-1267-3483
Mark T DransfieldDivision of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, Alabama, USA.
David M G HalpinUniversity of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, UK.ORCID 0000-0003-2009-4406
MeiLan K HanPulmonary & Critical Care, University of Michigan, Ann Arbor, Michigan, USA.
David A LipsonGlaxoSmithKline, Collegeville, Pennsylvania, USA.ORCID 0000-0001-6732-4593
Ghassan J MaghzalGSK, Melbourne, Victoria, Australia.
Fernando J MartinezWeill Cornell Medicine, New York, New York, USA.
Dawn MidwinterGSK, Brentford, UK.ORCID 0000-0003-2434-1152
Dave SinghCentre for Respiratory Medicine and Allergy, Institute of Inflammation and Repair, Manchester Academic Health Science Centre, The University of Manchester, Manchester University NHS Foundation Hospital Trust, Manchester, UK.ORCID 0000-0001-8918-7075
Lee TombsPrecise Approach Limited, London, UK.
Robert A WiseDivision of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Cornell University · USGlaxoSmithKline (Australia) · AUGlaxoSmithKline (United States) · USHollywood Orthopaedic Group · AUJohns Hopkins University · USManchester Academic Health Science Centre · GBSound Approach (United Kingdom) · GBTemple University · USUniversity of Alabama at Birmingham · USUniversity of Exeter · GBUniversity of Michigan · US

Funding

Department of Health
6 · The paper itself

Abstract

BACKGROUND AND

objectiveChronic mucus hypersecretion (CMH) is a clinical phenotype of COPD. This exploratory post hoc analysis assessed relationship between CMH status and treatment response in IMPACT.

methodsPatients were randomized to once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 μg, FF/VI 100/25 μg or UMEC/VI 62.5/25 μg and designated CMH+ if they scored 1/2 in St George's Respiratory Questionnaire (SGRQ) questions 1 and 2. Endpoints assessed by baseline CMH status included on-treatment exacerbation rates, change from baseline in trough forced expiratory volume in 1 second, SGRQ total score, COPD Assessment Test (CAT) score, proportion of SGRQ and CAT responders at Week 52 and safety.

resultsOf 10,355 patients in the intent-to-treat population, 10,250 reported baseline SGRQ data (CMH+: 62% [n = 6383]). FF/UMEC/VI significantly (p < 0.001) reduced on-treatment moderate/severe exacerbation rates versus FF/VI and UMEC/VI in CMH+ (rate ratio: 0.87 and 0.72) and CMH- patients (0.82 and 0.80). FF/UMEC/VI significantly (p < 0.05) reduced on-treatment severe exacerbation rates versus UMEC/VI in CMH+ (0.62) and CMH- (0.74) subgroups. Similar improvements in health status and lung function with FF/UMEC/VI were observed, regardless of CMH status. In CMH+ patients, FF/VI significantly (p < 0.001) reduced on-treatment moderate/severe and severe exacerbation rates versus UMEC/VI (0.83 and 0.70).

conclusionFF/UMEC/VI had a favourable benefit: risk profile versus dual therapies irrespective of CMH status. The presence of CMH did not influence treatment response or exacerbations, lung function and/or health status. However, CMH did generate differences when dual therapies were compared and the impact of CMH should be considered in future trial design.

Indexed as

Bronchodilator AgentsPulmonary Disease, Chronic ObstructiveAdministration, InhalationAndrostadienesBenzyl AlcoholsChlorobenzenesDouble-Blind MethodDrug CombinationsFluticasoneForced Expiratory VolumeHumansMucusTreatment OutcomeAndrostadienesBenzyl AlcoholsBronchodilator AgentsChlorobenzenesDrug CombinationsFluticasonevilanterolchronic mucus hypersecretionchronic obstructive pulmonary diseaseclinical outcomesCOPDsingle-inhaler triple therapy

Identifiers

PMID35970518
PMCPMC9804213
OpenAlexW4291755115

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.