Evidence map›Paper›PMID 32918892›Full record

Trial reportThe Lancet. Respiratory medicine2021

Efficacy and safety of once-daily single-inhaler triple therapy (FF/UMEC/VI) versus FF/VI in patients with inadequately controlled asthma (CAPTAIN): a double-blind, randomised, phase 3A trial.

Laurie A Lee, Zelie Bailes, Neil Barnes, Louis-Philippe Boulet, Dawn Edwards, Andrew Fowler, Nicola A Hanania, Huib A M Kerstjens, Edward Kerwin, Robert Nathan and 8 more

Erratum issued 2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Publisher
In one paragraph

Trial report in The Lancet. Respiratory medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 118 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
118citing papers in PubMed, 6 pooled it
16.6field-weighted citation impact, top 1% 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.

NCT05292586 phase3completednot on this mapstarted 2022, after this paper: background citation

A 12 Week, Randomized, Double-blind, Multicenter, Active Controlled, 2-Arm Parallel Group Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose (Fixed Combination of Extrafine Beclomethasone Dipropionate Plus Formoterol Fumarate) Compared to CHF 718 pMDI 800µg Total Daily Dose (Extrafine Beclomethasone Dipropionate) in Adults With Asthma on Medium or High-Dose Inhaled Corticosteroid

TypeinterventionalSponsorChiesi Farmaceutici S.p.A.Ran2022 to 2024Enrolled1,377ConditionsAsthmaArmsBeclomethasone Dipropionate/Formoterol Fumarate, Beclomethasone Dipropionate
NCT05870215 completednot on this mapstarted 2022, after this paper: background citation

Phenotyping Responses to Systemic Corticosteroids in the Management of Asthma Attacks (PRISMA): Clinical and Translational Correlation to Point-Of-Care Biomarkers

TypeobservationalSponsorUniversité de SherbrookeRan2022 to 2024Enrolled78ConditionsAsthmaArmsVisit 1: Clinical exam and questionnaires, Visit 1: Respiratory physiology, Visit 1: Inflammometry, Visit 2: Clinical exam and questionnaires, Visit 2: Respiratory physiology
3 · Its place in the literature

Who cites it

118 citing papers in PubMed, 6 syntheses or guidelines pooled it, 243 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Article
  13. Article
  14. Article
  15. Article
  16. Observational
  17. Mechanisms and therapeutic strategies of asthma: from bench to bedside.Signal transduction and targeted therapy · 2026
    Review
  18. Article
  19. Phenotyping treatment-naive uncontrolled asthma in adults: A primary care framework.The journal of allergy and clinical immunology. Global · 2026
    Article
  20. Review

58 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 10 institutions in 6 countries.

Laurie A LeeGlaxoSmithKline (GSK), Collegeville, PA, USA.
Zelie BailesGSK, Stockley Park West, Uxbridge, Middlesex, UK.
Neil BarnesGSK, Brentford, Middlesex, UK; Barts and the London School of Medicine and Dentistry, London, UK.
Louis-Philippe BouletLaval University, Quebec, QC, Canada.
Dawn EdwardsGSK, Stockley Park West, Uxbridge, Middlesex, UK.
Andrew FowlerGSK, Stockley Park West, Uxbridge, Middlesex, UK.
Nicola A HananiaSection of Pulmonary and Critical Care Medicine, Baylor College of Medicine, Houston, TX, USA.
Huib A M KerstjensUniversity of Groningen and University Medical Center Groningen, and Groningen Research Institute for Asthma and COPD, Groningen, Netherlands.
Edward KerwinCrisor, Clinical Research Institute, Medford, OR, USA.
Robert NathanAsthma & Allergy Associates, PC and Research Center, Colorado Springs, CO, USA.
John OppenheimerRutgers New Jersey Medical School, Newark, NJ, USA.
Alberto PapiUniversity of Ferrara, Ferrara, Italy.
Steven PascoeGlaxoSmithKline (GSK), Collegeville, PA, USA.
Guy BrusselleGhent University Hospital, Ghent, Belgium.
Guy PeacheyGSK, Stockley Park West, Uxbridge, Middlesex, UK.
Neal SuleGlaxoSmithKline (GSK), Collegeville, PA, USA.
Maggie TabbererGSK, Stockley Park West, Uxbridge, Middlesex, UK.
Ian D PavordNuffield Department of Medicine and Oxford Respiratory NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, UK. Electronic address: ian.pavord@ndm.ox.ac.uk.
GlaxoSmithKline (United States) · USBaylor College of Medicine · USClinical Research Institute · USGhent University Hospital · BEQueen Mary University of London · GBRutgers, The State University of New Jersey · USUniversité Laval · CAUniversity of Ferrara · ITUniversity of Groningen · NLUniversity of Oxford · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDespite inhaled corticosteroid plus long-acting β

methodsIn this double-blind, randomised, parallel-group, phase 3A study (Clinical Study in Asthma Patients Receiving Triple Therapy in a Single Inhaler [CAPTAIN]), participants were recruited from 416 hospitals and primary care centres across 15 countries. Participants were eligible if they were aged 18 years or older, with inadequately controlled asthma (Asthma Control Questionnaire [ACQ]-6 score of ≥1·5) despite ICS/LABA, a documented health-care contact or a documented temporary change in asthma therapy for treatment of acute asthma symptoms in the year before screening, pre-bronchodilator FEV

findingsBetween Dec 16, 2016, and Aug 31, 2018, 5185 patients were screened and 2439 were recruited and randomly assigned to FF/VI (100/25 μg n=407; 200/25 μg n=406) or FF/UMEC/VI (100/31·25/25 μg n=405; 100/62·5/25 μg n=406; 200/31·25/25 μg n=404; 200/62·5/25 μg n=408), with three patients randomly assigned in error and not included in analyses. In the intention-to-treat population, 922 (38%) patients were men, the mean age was 53·2 years (SD 13·1) and body-mass index was 29·4 (6·6). Baseline demographics were generally similar across all treatment groups. The least squares mean improvement in FEV

interpretationIn patients with uncontrolled moderate or severe asthma on ICS/LABA, adding UMEC improved lung function but did not lead to a significant reduction in moderate and/or severe exacerbations. For such patients, single-inhaler FF/UMEC/VI is an effective treatment option with a favourable risk-benefit profile. Higher dose FF primarily reduced the rate of exacerbations, particularly in patients with raised biomarkers of type 2 airway inflammation. Further confirmatory studies into the differentiating effect of type 2 inflammatory biomarkers on treatment outcomes in asthma are required to build on these exploratory findings and further guide clinical practice.

fundingGSK.

Indexed as

Administration, InhalationAndrostadienesAnti-Asthmatic AgentsAsthmaBenzyl AlcoholsChlorobenzenesDouble-Blind MethodDrug Therapy, CombinationFemaleHumansMaleMiddle AgedNebulizers and VaporizersQuinuclidinesAndrostadienesAnti-Asthmatic AgentsBenzyl AlcoholsChlorobenzenesfluticasone furoateGSK573719Quinuclidinesvilanterol

Identifiers

PMID32918892
OpenAlexW3084377968

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.