Evidence map›Paper›PMID 32152869›Full record

Trial reportAdvances in therapy2020

Efficacy and Safety of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler in Chinese Patients with COPD: A Subgroup Analysis of KRONOS.

Chen Wang, Ting Yang, Jian Kang, Rongchang Chen, Li Zhao, Huijie He, Pryseley N Assam, Rong Su, Eric Bourne, Shaila Ballal and 2 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Advances in therapy, 2020. 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 11 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 6 pooled it
1.4field-weighted citation impact, top 16% 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.

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

11 citing papers in PubMed, 6 syntheses or guidelines pooled it, 16 citations in OpenAlex.

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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

12 authors at 6 institutions in 2 countries.

Chen WangDepartment of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, No. 2, East Yinghua Street, Chaoyang District, Beijing, 100029, China. cyh-birm@263.net.
Ting YangDepartment of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, No. 2, East Yinghua Street, Chaoyang District, Beijing, 100029, China.
Jian KangThe First Hospital of China Medical University, Shenyang, China.
Rongchang ChenThe First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Li ZhaoShengjing Hospital of China Medical University, Shenyang, China.
Huijie HeThe First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology, Baotou, Inner Mongolia, China.
Pryseley N AssamAstraZeneca, Shanghai, China.
Rong SuAstraZeneca, Shanghai, China.
Eric BourneAstraZeneca, Durham, NC, USA.
Shaila BallalAstraZeneca, Morristown, NJ, USA.
Kiernan DeAngelisFormerly of AstraZeneca, Durham, NC, USA.
Paul DorinskyAstraZeneca, Durham, NC, USA.
AstraZeneca (United States) · USChina Medical University · CNCapital Medical University · CNChina-Japan Friendship Hospital · CNGuangzhou Medical University · CNInner Mongolia University of Science and Technology · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis pre-specified subgroup analysis evaluated the efficacy and safety of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI) triple therapy versus corresponding dual therapies in the China subgroup of the phase III, double-blind KRONOS study in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).

methodsPatients were randomized 2:2:1:1 to BGF MDI 320/18/9.6 μg, glycopyrrolate/formoterol fumarate (GFF) MDI 18/9.6 μg, budesonide/formoterol fumarate (BFF) MDI 320/9.6 μg, or budesonide/formoterol fumarate dry powder inhaler (BUD/FORM DPI) 400/12 μg twice daily for 24 weeks. The primary endpoint was change from baseline in morning pre-dose trough forced expiratory volume in 1 s (FEV

resultsIn the China subgroup (n = 432; 22.7% of the KRONOS population), BGF MDI demonstrated nominally significant improvements in the primary endpoint versus BFF MDI (least squares mean (LSM) difference 68 mL; P = 0.0035) and BUD/FORM DPI (LSM difference 78 mL; P = 0.0010) but not GFF MDI (LSM difference - 4 mL; P = 0.8316). BGF MDI demonstrated at least numerical improvements versus comparators in secondary lung function and symptom endpoints. BGF MDI reduced the rate of moderate/severe COPD exacerbations versus GFF MDI (rate ratio 0.41; P = 0.0030), with numerical benefits versus BFF MDI and BUD/FORM DPI. All treatments were well tolerated.

conclusionsResults demonstrated that BGF MDI showed benefits on lung function (vs inhaled corticosteroid/long-acting β CLINICAL

trial registrationClinicalTrials.gov NCT02497001.

Indexed as

Administration, InhalationAdultAgedBronchodilator AgentsBudesonideChinaDose-Response Relationship, DrugDouble-Blind MethodDrug CombinationsFemaleForced Expiratory VolumeFormoterol FumarateGlycopyrrolateHumansMaleMetered Dose InhalersBronchodilator AgentsBudesonideDrug CombinationsFormoterol FumarateGlycopyrrolateBronchodilator agentsChinaChronic obstructiveDisease exacerbationPulmonary diseasePulmonary function tests

Identifiers

PMID32152869
PMCPMC7140742
OpenAlexW3009236575

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.