Evidence map›Paper›PMID 40044194›Full record

ArticleBMJ open2025

Predictors of treatment REsponse to inhaled corticosteroids (ICS) in Chronic Obstructive pulmonary disease: randomised controlled trials individual participant Data re-Evaluation-protocol of the ICS-RECODE individual participant data meta-analysis.

Sebastian Bate, Rebecca Fortescue, Catherine Fullwood, Matthew Sperrin, Mark Simmonds, Markus Fally, Jan Hansel, Michael Miligkos, Sinduja Manohar, Emily Howlett and 8 more

Abstract read
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

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

1 citing paper in PubMed.

  1. Article
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

18 authors.

Sebastian BateResearch and Innovation, Manchester University NHS Foundation Trust, Manchester, UK.
Rebecca FortescuePopulation Health Research Institute, St George's University of London, London, UK.
Catherine FullwoodResearch and Innovation, Manchester University NHS Foundation Trust, Manchester, UK.ORCID http://orcid.org/0000-0003-4136-2027
Matthew SperrinCentre for Health Informatics, Imaging and Data Science, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.ORCID http://orcid.org/0000-0002-5351-9960
Mark SimmondsCentre for Reviews and Dissemination, University of York, York, UK.ORCID http://orcid.org/0000-0002-1999-8515
Markus FallyDepartment of Respiratory Medicine and Infectious Diseases, Copenhagen University Hospital-Bispebjerg and Frederiksberg, Copenhagen University Hospital, Kobenhavn, Denmark.ORCID http://orcid.org/0000-0002-1339-2918
Jan HanselDivision of Immunology, Immunity to Infection and Respiratory Medicine, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.ORCID http://orcid.org/0000-0003-2858-1313
Michael MiligkosAllergy Department, 2nd Paediatric Clinic, National and Kapodistrian University of Athens, Athens, Greece.
Sinduja ManoharVocal, Manchester University NHS Foundation Trust, Manchester, UK.
Emily HowlettVocal, Manchester University NHS Foundation Trust, Manchester, UK.
John LinnellVocal, Manchester University NHS Foundation Trust, Manchester, UK.
Alan PrestonVocal, Manchester University NHS Foundation Trust, Manchester, UK.
ICS-RECODE group
Ashley A WoodcockNorth West Lung Centre, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
Dave SinghDivision of Immunology, Immunity to Infection and Respiratory Medicine, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.
Lesley StewartCentre for Reviews and Dissemination, University of York, York, UK.
Joergen VestboDivision of Immunology, Immunity to Infection and Respiratory Medicine, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK alexander.mathioudakis@manchester.ac.uk jorgen.vestbo@manchester.ac.uk.
Alexander G MathioudakisDivision of Immunology, Immunity to Infection and Respiratory Medicine, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK alexander.mathioudakis@manchester.ac.uk jorgen.vestbo@manchester.ac.uk.ORCID http://orcid.org/0000-0002-4675-9616

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionInhaled corticosteroids (ICS) can improve clinical outcomes in patients with chronic obstructive pulmonary disease (COPD) and eosinophilic airway inflammation, but they also increase the risk of side effects like pneumonia. Blood eosinophils guide ICS use, though evidence is limited. The predictors of treatment REsponse to ICS in COPD: a randomised controlled trials (RCTs) individual participant Data re-Evaluation (ICS-RECODE) research programme will leverage data from large RCTs to identify patients who benefit most from ICS with minimal risk. This protocol details an individual participant data (IPD) meta-analysis, assessing ICS safety, efficacy and treatment×covariate interactions to identify predictors of treatment response. METHODS AND ANALYSIS: This meta-analysis will adhere to Cochrane, IPD handbook and Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidance. We will conduct a two-stage IPD meta-analysis of RCTs evaluating the addition of ICS to maintenance COPD treatments. Only RCTs with at least 500 participants across all eligible arms will be included, to allow for treatment×covariate interaction evaluation. Primary outcomes are severe and moderate or severe exacerbation rates; secondary outcomes assess both safety and efficacy. Data from each RCT will be reanalysed using rigorous, consistent statistical methods. Treatment×covariate interactions will be assessed at the RCT level. Trial treatment effects and the coefficients of treatment×covariate interaction analyses will be pooled using random effects model meta-analysis. Risk of bias will be appraised using RoB-2 informed by IPD, and certainty of evidence will be assessed with GRADE and the Instrument to assess the Credibility of Effect Modification Analyses.The ICS-RECODE IPD meta-analysis will make use of the best available data to define evidence-based, precision medicine approaches for ICS use in COPD. ETHICS AND DISSEMINATION: The Health Research Authority approved the ICS-RECODE study, exempting it from ethics review (HRA UK, Reference: 24/HRA/0460). Our findings will be published in peer-reviewed journals and shared with the scientific and broader stakeholder communities. PROSPERO REGISTRATION NUMBER: CRD42024508286.

Indexed as

Adrenal Cortex HormonesPulmonary Disease, Chronic ObstructiveAdministration, InhalationHumansMeta-Analysis as TopicRandomized Controlled Trials as TopicResearch DesignTreatment OutcomeAdrenal Cortex HormonesMeta-AnalysisPulmonary Disease, Chronic ObstructiveRandomized Controlled TrialSystematic Review

Identifiers

PMID40044194
PMCPMC11883585

What OpenQuestion holds

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Registered trials

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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.