Evidence map›Paper›PMID 39103901›Full record

Trial reportRespiratory research2024

Benefits of budesonide/glycopyrronium/formoterol fumarate dihydrate on lung function and exacerbations of COPD: a post-hoc analysis of the KRONOS study by blood eosinophil level and exacerbation history.

Shigeo Muro, Tomotaka Kawayama, Hisatoshi Sugiura, Munehiro Seki, Elizabeth A Duncan, Karin Bowen, Jonathan Marshall, Ayman Megally, Mehul Patel

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Respiratory research, 2024. 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 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Trial
  2. Observational
  3. Article
  4. 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

9 authors.

Shigeo MuroDepartment of Respiratory Medicine, Nara Medical University, 840 Shijo-cho, Nara, 634-8522, Japan. smuro@naramed-u.ac.jp.ORCID http://orcid.org/0000-0001-7452-9191
Tomotaka KawayamaDivision of Respirology, Neurology and Rheumatology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan.
Hisatoshi SugiuraDepartment of Respiratory Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.
Munehiro SekiRespiratory Inhalation, Medical Department, AstraZeneca K.K. Kita-ku, Osaka, Japan.
Elizabeth A DuncanFormerly of AstraZeneca, Durham, NC, USA.
Karin BowenLate RIA Biometrics, AstraZeneca, Gaithersburg, MD, USA.
Jonathan MarshallBioPharmaceuticals, R&I Medical, AstraZeneca, Cambridge, UK.
Ayman MegallyLate RIA, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Mehul PatelLate RIA, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.ORCID http://orcid.org/0000-0003-0435-858X

Funding

AstraZeneca N/A
6 · The paper itself

Abstract

backgroundJapanese guidelines recommend triple inhaled corticosteroid (ICS)/long-acting muscarinic antagonist (LAMA)/long-acting β

methodsIn KRONOS, patients were randomized to receive treatments that included BGF 320/14.4/10 µg, glycopyrronium/formoterol fumarate dihydrate (GFF) 14.4/10 µg, or budesonide/formoterol fumarate dihydrate (BFF) 320/10 µg via metered dose inhaler (two inhalations twice-daily for 24 weeks). These post-hoc analyses assessed changes from baseline in morning pre-dose trough forced expiratory volume in 1 s (FEV

resultsAmong patients with blood EOS count 100 to < 300 cells/mm

conclusionsThese post-hoc analyses of patients with moderate-to-very severe COPD from the KRONOS study seem to indicate clinicians may want to consider a step-up to triple therapy in patients with persistent/worsening symptoms with blood EOS count > 100 cells/mm

trial registrationClinicalTrials.gov registry number NCT02497001 (registration date, 13 July 2015).

Indexed as

Bronchodilator AgentsBudesonideEosinophilsFormoterol FumarateGlycopyrrolatePulmonary Disease, Chronic ObstructiveAdministration, InhalationAgedDisease ProgressionDouble-Blind MethodFemaleForced Expiratory VolumeHumansLungMaleMiddle AgedBronchodilator AgentsBudesonideFormoterol FumarateGlycopyrrolateMuscarinic AntagonistsBlood eosinophilsBudesonide/glycopyrronium/formoterol fumarate dihydrate (BGF)Chronic obstructive pulmonary disease (COPD)Disease severityExacerbation ratesFixed-dose triple therapyLung function

Identifiers

PMID39103901
PMCPMC11302094

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.