Evidence map›Paper›PMID 31920296›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease2019

Long-Term Safety and Efficacy of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Formulated Using Co-Suspension Delivery Technology in Japanese Patients with COPD.

Masakazu Ichinose, Yasushi Fukushima, Yoshikazu Inoue, Osamu Hataji, Gary T Ferguson, Klaus F Rabe, Nobuya Hayashi, Hiroshi Okada, Mami Takikawa, Eric Bourne and 5 more

2 registry-linked trialsOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of chronic obstructive pulmonary disease, 2019. 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 10 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 4 pooled it
1.4field-weighted citation impact, top 17% 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
NCT03262012 phase3completednot on this map

A Randomized, Double-Blind, Parallel-Group, 28-Week, Chronic-Dosing, Multi-Center, Extension Study to Assess the Safety and Efficacy of PT010, PT003, and PT009 in Japanese Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) Compared With Symbicort® Turbuhaler® as an Active Control

TypeinterventionalSponsorPearl Therapeutics, Inc.Ran2016 to 2018Enrolled416ConditionsCOPDArmsBGF MDI (PT010), GFF MDI (PT003), BFF MDI (PT009), Symbicort® Turbohaler® Inhalation Powder
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 4 syntheses or guidelines pooled it, 44 citations in OpenAlex.

  1. Pooled it
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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

15 authors at 7 institutions in 4 countries.

Masakazu IchinoseDepartment of Respiratory Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.
Yasushi FukushimaDepartment of Internal Medicine, Fukuwa Clinic, Tokyo, Japan.ORCID 0000-0002-6148-215X
Yoshikazu InoueClinical Research Center, National Hospital Organization, Kinki-Chuo Chest Medical Center, Osaka, Japan.ORCID 0000-0003-3994-874X
Osamu HatajiRespiratory Center, Matsusaka Municipal Hospital, Matsusaka, Japan.
Gary T FergusonPulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.
Klaus F RabeLungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, Member of the German Center for Lung Research (DZL), Großhansdorf, Germany.
Nobuya HayashiAstraZeneca K.K., Osaka, Japan.ORCID 0000-0002-5386-5599
Hiroshi OkadaAstraZeneca K.K., Osaka, Japan.ORCID 0000-0003-4985-5432
Mami TakikawaAstraZeneca K.K., Osaka, Japan.
Eric BourneAstraZeneca, Durham, NC, USA.
Shaila BallalAstraZeneca, Morristown, NJ, USA.
Kiernan DeAngelisFormerly of AstraZeneca, Durham, NC, USA.ORCID 0000-0003-0807-6766
Magnus AurivilliusAstraZeneca, Gothenburg, Sweden.
Colin ReisnerAstraZeneca, Morristown, NJ, USA.ORCID 0000-0003-1856-9863
Paul DorinskyAstraZeneca, Durham, NC, USA.ORCID 0000-0002-4814-0657
AstraZeneca (United States) · USAstraZeneca (Japan) · JPAstraZeneca (Sweden) · SEGerman Center for Lung Research · DENHO Kinki Chuo Chest Medical Center · JPSoka Municipal Hospital · JPTohoku University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI) is a triple fixed-dose combination for COPD. The long-term safety of triple therapy for COPD has not been investigated in Japanese patients. In this 28-week extension study (NCT03262012), we investigated the long-term safety and tolerability of BGF MDI in Japanese patients with moderate-to-very severe COPD who completed the 24-week Phase III randomized, double-blind, multicenter KRONOS study (NCT02497001). Materials and methods: Patients randomized 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 in KRONOS continued treatment for up to 28 additional weeks. Safety was evaluated over 52 weeks via adverse event (AE) monitoring, electrocardiograms, clinical laboratory testing, and vital sign measurements. Results: The safety population included 416 patients who received BGF MDI (n=139), GFF MDI (n=138), BFF MDI (n=70), or BUD/FORM DPI (n=69). Treatment-emergent AE (TEAE) rates were similar across treatment groups (range: 82.6-82.9%). The most frequent TEAEs overall were nasopharyngitis (32.2%) and bronchitis (9.9%). The incidence of major adverse cardiovascular events was low across groups (range: 0.0-2.9%). Over 52 weeks, the incidence of confirmed pneumonia was 9.4% (BGF MDI), 3.6% (GFF MDI), 5.7% (BFF MDI), and 2.9% (BUD/FORM DPI); in the 28-week extension period, rates were comparable across groups (range: 2.9-5.7%). Six deaths were reported (0.7-2.2% per group); none were considered treatment-related. No clinically meaningful trends were observed in electrocardiograms, laboratory parameters, or vital signs over time in any of the treatment groups. Conclusion: All treatments were well tolerated over 52 weeks, and the safety profile of BGF MDI was generally comparable to dual long-acting muscarinic antagonist (LAMA)/long-acting β

Indexed as

Metered Dose InhalersPulmonary Disease, Chronic ObstructiveBronchodilator AgentsBudesonideDouble-Blind MethodDrug CombinationsDrug MonitoringDrug ToleranceFemaleFormoterol FumarateGlycopyrrolateHumansJapanMaleMiddle AgedRespiratory Function TestsBronchodilator AgentsBudesonideDrug CombinationsFormoterol FumarateGlycopyrrolateco-suspension delivery technologyICS/LAMA/LABAinhaled corticosteroidJapanlong-acting muscarinic antagonistlong-acting β2-agonist

Identifiers

PMID31920296
PMCPMC6934178
OpenAlexW2995635209

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.