Evidence map›Paper›PMID 34428980›Full record

Trial reportTherapeutic advances in respiratory disease

Improvements in lung function with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler

Klaus F Rabe, Fernando J Martinez, Dave Singh, Roopa Trivedi, Martin Jenkins, Patrick Darken, Magnus Aurivillius, Paul Dorinsky

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Therapeutic advances in respiratory disease. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
2.5field-weighted citation impact, top 10% 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.

NCT02465567 phase3completednot on this map

A Randomized, Double-Blind, Multi-Center, Parallel-Group Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD (Ethos)

TypeinterventionalSponsorPearl Therapeutics, Inc.Ran2015 to 2019Enrolled8,588ConditionsCOPDArmsBGF MDI 320/14.4/9.6 μg, GFF MDI 14.4/9.6 μg, BGF MDI 160/14.4/9.6 μg, BFF MDI 320/9.6 μg
NCT06905483 phase4completednot on this map

Comparative Effects of Triple Inhaled Therapy With Budesonide/Glycopyrronium/Formoterol Versus Fluticasone Furoate/Umeclidinium/Vilanterol on Small Airway Disease in COPD Patients: A Randomized Crossover Study

TypeinterventionalSponsorThammasat UniversityRan2025 to 2026Enrolled22ConditionsCOPD, Chronic Obstructive Pulmonary Disease (COPD), Small Airway Disease, Triple TherapyArmsBudesonide/Glycopyrronium/Formoterol (BGF), Fluticasone Furoate/Umeclidinium/Vilanterol (FUV)
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 27 citations in OpenAlex.

  1. Trial
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  14. Is Disease Stability an Attainable Chronic Obstructive Pulmonary Disease Treatment Goal?American journal of respiratory and critical care medicine · 2025
    Review
  15. Observational
  16. Associations between the EQ-5D-5L and exacerbations of chronic obstructive pulmonary disease in the ETHOS trial.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2024
    Article
  17. Article
  18. Article
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  20. Benefit/Risk Profile of Single-Inhaler Triple Therapy in COPD.International journal of chronic obstructive pulmonary disease
    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

8 authors at 6 institutions in 4 countries.

Klaus F RabeLungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, Member of the German Center for Lung Research (DZL), Grosshansdorf 22927, Germany.ORCID 0000-0002-7020-1401
Fernando J MartinezJoan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York, NY, USA.
Dave SinghMedicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.
Roopa TrivediAstraZeneca, Durham, NC, USA.
Martin JenkinsAstraZeneca, Cambridge, UK.
Patrick DarkenAstraZeneca, Gaithersburg, MD, USA.
Magnus AurivilliusAstraZeneca, Gothenburg, Sweden.
Paul DorinskyAstraZeneca, Durham, NC, USA.
AstraZeneca (United States) · USAstraZeneca (Sweden) · SEAstraZeneca (United Kingdom) · GBCornell University · USGerman Center for Lung Research · DEManchester University NHS Foundation Trust · GB

Funding

Department of Health
6 · The paper itself

Abstract

backgroundIn the phase III, 52-week ETHOS study in patients with moderate to very severe chronic obstructive pulmonary disease (COPD), triple therapy with budesonide/glycopyrrolate/formoterol fumarate (BGF), at two inhaled corticosteroid dose levels, resulted in significantly lower moderate/severe exacerbation rates

methodsETHOS (NCT02465567) was a randomized, double-blind, multi-center, parallel-group study in patients with moderate to very severe COPD who had experienced ⩾1 moderate/severe exacerbation in the previous year. Patients received BGF 320/18/9.6 µg, BGF 160/18/9.6 μg, GFF 18/9.6 µg, or BFF 320/9.6 µg twice daily

resultsThe PFT modified intent-to-treat population included 3088 patients (mean age 64.4 years; mean reversibility post-albuterol 16.7%; mean post-albuterol FEV

conclusionsBGF 320/18/9.6 µg and 160/18/9.6 µg significantly improved trough FEV

Indexed as

LungPulmonary Disease, Chronic ObstructiveBudesonideBudesonide, Formoterol Fumarate Drug CombinationDouble-Blind MethodFormoterol FumarateGlycopyrrolateHumansMetered Dose InhalersMiddle AgedTreatment OutcomeBudesonideBudesonide, Formoterol Fumarate Drug CombinationFormoterol FumarateGlycopyrrolateBGF metered dose inhalerchronic obstructive pulmonary diseaseinhaled corticosteroid/long-acting muscarinic antagonist/long-acting β2-agonist (ICS/LAMA/LABA)pulmonary functiontriple therapy

Identifiers

PMID34428980
PMCPMC8392797
OpenAlexW3193811270

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.