Evidence map›Paper›PMID 40340809›Full record

Trial reportRespiratory research2025

Step up to triple therapy versus switch to dual bronchodilator therapy in patients with COPD on an inhaled corticosteroid/long-acting β

Dave Singh, Mona Bafadhel, Niki Arya, Jonathan Marshall, Himanshu Parikh, Dobrawa Kisielewicz, Charlotta Movitz, Karin Bowen, Mehul Patel

Registry-linked trialAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Respiratory research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02497001 (A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® as an Active Control in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease), which is not on this 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.

NCT02497001 phase3completednot on this map

A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® as an Active Control in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

TypeinterventionalSponsorPearl Therapeutics, Inc.Ran2015 to 2018Enrolled1,902ConditionsCOPDArmsBGF MDI 320/14.4/9.6 μg, GFF MDI (PT003) 14.4/9.6 μg, BFF MDI (PT009) 320/9.6 μg, Symbicort® Turbuhaler® (TBH) Inhalation Powder
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Observational
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

9 authors.

Dave SinghMedicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester, M23 9QZ, UK. dsingh@meu.org.uk.
Mona BafadhelKing's Centre for Lung Health, School of Immunology and Microbial Sciences, Faculty of Life Science and Medicine, King's College London, London, UK.
Niki AryaRespiratory and Immunology, Biometrics, BioPharmaceuticals R&D, AstraZeneca, Durham, NC, USA.
Jonathan MarshallGlobal Medical Affairs - Respiratory, BioPharmaceuticals Medical, AstraZeneca, Cambridge, UK.
Himanshu ParikhRespiratory and Immunology, Clinical Development, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Dobrawa KisielewiczRespiratory and Immunology, Clinical Development, Biopharmaceuticals R&D, AstraZeneca, Barcelona, Spain.
Charlotta MovitzRespiratory and Immunology, Biometrics, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Karin BowenRespiratory and Immunology, Biometrics, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Mehul PatelRespiratory and Immunology, Clinical Development, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn people with chronic obstructive pulmonary disease (COPD) on inhaled corticosteroid/long-acting β

methodsIn KRONOS (NCT02497001), symptomatic participants with moderate-to-very severe COPD (exacerbations in the prior year were not required for inclusion) were randomized to budesonide/glycopyrronium/formoterol fumarate dihydrate 320/14.4/10 μg (BGF), glycopyrronium/formoterol fumarate dihydrate 14.4/10 μg (GFF), budesonide/formoterol fumarate dihydrate 320/10 μg (BFF) via metered-dose inhaler, or budesonide/formoterol fumarate dihydrate 400/12 μg via dry-powder inhaler (BUD/FORM) for 24 weeks. In participants without a recent exacerbation history on ICS/LABA in the 30 days before screening, morning pre-dose trough FEV

resultsOn stepping up to BGF, least square means (95% confidence interval [CI]) differences for morning pre-dose trough FEV

conclusionsPeople with symptomatic COPD and no recent exacerbation history previously on ICS/LABA had reduced exacerbation risk after escalating to ICS/LAMA/LABA versus switching to LAMA/LABA, and improved lung function versus staying on ICS/LABA.

trial registrationClinicalTrials.gov registry number NCT02497001 (registration date, 7 July 2015).

Indexed as

Adrenal Cortex HormonesAdrenergic beta-2 Receptor AgonistsBronchodilator AgentsDrug SubstitutionPulmonary Disease, Chronic ObstructiveAdministration, InhalationAgedDouble-Blind MethodDrug CombinationsDrug Therapy, CombinationFemaleHumansMaleMiddle AgedMuscarinic AntagonistsTreatment OutcomeAdrenal Cortex HormonesAdrenergic beta-2 Receptor AgonistsBronchodilator AgentsDrug CombinationsMuscarinic AntagonistsChronic obstructive pulmonary diseaseExacerbationsLung functionTriple therapy

Identifiers

PMID40340809
PMCPMC12063277

What OpenQuestion holds

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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.