Evidence map›Paper›PMID 36510486›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease2022

Benefits of Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate on COPD Exacerbations, Lung Function, Symptoms, and Quality of Life Across Blood Eosinophil Ranges: A Post-Hoc Analysis of Data from ETHOS.

Mona Bafadhel, Klaus F Rabe, Fernando J Martinez, Dave Singh, Patrick Darken, Martin Jenkins, Magnus Aurivillius, Mehul Patel, Paul Dorinsky

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in International journal of chronic obstructive pulmonary disease, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02465567 (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), which is not on this map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
3.5field-weighted citation impact, top 6% 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
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 26 citations in OpenAlex.

  1. Trial
  2. Trial
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  4. Review
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  6. Review
  7. Article
  8. Short-acting βERJ open research · 2025
    Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. Review
  18. 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
  19. Review
  20. 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

9 authors at 7 institutions in 4 countries.

Mona BafadhelDepartment of Immunobiology, School of Immunology and Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.ORCID 0000-0002-9993-2478
Klaus F RabeLungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany.ORCID 0000-0002-7020-1401
Fernando J MartinezJoan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York, NY, USA.ORCID 0000-0002-2412-3182
Dave SinghMedicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester, UK.ORCID 0000-0001-8918-7075
Patrick DarkenAstraZeneca, Gaithersburg, MD, USA.ORCID 0000-0002-5608-2717
Martin JenkinsAstraZeneca, Cambridge, UK.
Magnus AurivilliusAstraZeneca, Gothenburg, Sweden.ORCID 0000-0003-4660-5040
Mehul PatelAstraZeneca, Cambridge, UK.ORCID 0000-0003-0435-858X
Paul DorinskyFormerly of AstraZeneca, Durham, NC, USA.ORCID 0000-0002-4814-0657
AstraZeneca (United Kingdom) · GBAstraZeneca (United States) · USAstraZeneca (Sweden) · SECornell University · USGerman Center for Lung Research · DEKing's College London · GBUniversity of Manchester · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: Blood eosinophil (EOS) count can guide treatment decisions for chronic obstructive pulmonary disease (COPD). In the 52-week ETHOS study (NCT02465567), budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) triple therapy at two inhaled corticosteroid doses reduced moderate/severe exacerbation rates and improved lung function, symptoms, and disease-related quality of life (QoL) versus dual therapy with glycopyrronium/formoterol fumarate dihydrate (GFF) or budesonide/formoterol fumarate dihydrate (BFF) in patients with moderate-to-very severe COPD. This subgroup analysis evaluated treatment benefits in ETHOS by baseline EOS count. Methods: Patients (40-80 years) with a COPD history were randomly assigned 1:1:1:1 to receive BGF 320/14.4/10 µg, BGF 160/14.4/10 µg, GFF 14.4/10 µg, or BFF 320/10 µg via a metered-dose inhaler. This post-hoc analysis assessed endpoints by baseline EOS count using Global Initiative for Obstructive Lung Disease thresholds (<100, ≥100, ≥100-<300, ≥300 cells/mm Results: In the modified intention-to-treat population (n=8509), 82.6% had EOS counts ≥100 cells/mm Conclusion: Benefits of BGF versus GFF were observed across EOS counts, particularly at ≥100 cells/mm³; versus BFF, benefits were largely independent of EOS. These findings confirm that benefits of ICS-containing triple therapy are not restricted to EOS counts ≥300 cells/mm³, supporting recommendations to consider triple therapy in patients with an exacerbation history and EOS counts ≥100 cells/mm³.

Indexed as

GlycopyrrolatePulmonary Disease, Chronic ObstructiveAdministration, InhalationBronchodilator AgentsBudesonideDouble-Blind MethodDrug CombinationsFormoterol FumarateHumansLungQuality of LifeBronchodilator AgentsBudesonideDrug CombinationsFormoterol FumarateGlycopyrrolateeosinophilsinhaled corticosteroidstriple therapy

Identifiers

PMID36510486
PMCPMC9738173
OpenAlexW4310713300

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.