Evidence map›Paper›PMID 32471423›Full record

Trial reportRespiratory research2020

Once-daily single-inhaler versus twice-daily multiple-inhaler triple therapy in patients with COPD: lung function and health status results from two replicate randomized controlled trials.

Gary T Ferguson, Nicola Brown, Chris Compton, Thomas C Corbridge, Kelly Dorais, Charles Fogarty, Catherine Harvey, Morrys C Kaisermann, David A Lipson, Neil Martin and 4 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IVComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Respiratory research, 2020. 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 23 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 4 pooled it
2.9field-weighted citation impact, top 7% 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.

NCT03478683 phase4completednot on this map

A Phase IV, 12-week, Randomised, Double-blind, Triple Dummy Study to Compare Single Inhaler Triple Therapy, Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) With Multiple Inhaler Therapy (Budesonide/Formoterol Plus Tiotropium) Based on Lung Function and Symptoms in Participants With Chronic Obstructive Pulmonary Disease

TypeinterventionalSponsorGlaxoSmithKlineRan2018 to 2019Enrolled729ConditionsPulmonary Disease, Chronic ObstructiveArmsbudesonide/formoterol, albuterol/salbutamol, FF/UMEC/VI, Placebo to match budesonide/formoterol, tiotropium
NCT03478696 phase4completednot on this map

A Phase IV, 12-week, Randomised, Double-blind, Triple Dummy Study to Compare Single Inhaler Triple Therapy, Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) With Multiple Inhaler Therapy (Budesonide/Formoterol Plus Tiotropium) Based on Lung Function and Symptoms in Participants With Chronic Obstructive Pulmonary Disease

TypeinterventionalSponsorGlaxoSmithKlineRan2018 to 2019Enrolled732ConditionsPulmonary Disease, Chronic ObstructiveArmsbudesonide/formoterol, albuterol/salbutamol, FF/UMEC/VI, Placebo to match budesonide/formoterol, tiotropium
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 4 syntheses or guidelines pooled it, 39 citations in OpenAlex.

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  5. Peak Inspiratory Flow Rate in COPD: An Analysis of Clinical Trial and Real-World Data.International journal of chronic obstructive pulmonary disease
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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

14 authors at 8 institutions in 2 countries.

Gary T FergusonPulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.
Nicola BrownGlaxoSmithKline, Stockley Park, Uxbridge, Middlesex, UK.
Chris ComptonGlaxoSmithKline, Brentford, Middlesex, UK.
Thomas C CorbridgeGlaxoSmithKline, Research Triangle Park, NC, USA.
Kelly DoraisGlaxoSmithKline, Collegeville, PA, USA.
Charles FogartySpartanburg Medical Research, Spartanburg, SC, USA.
Catherine HarveyGlaxoSmithKline, Stockley Park, Uxbridge, Middlesex, UK.
Morrys C KaisermannGlaxoSmithKline, Collegeville, PA, USA.
David A LipsonGlaxoSmithKline, Collegeville, PA, USA.
Neil MartinGlaxoSmithKline, Brentford, Middlesex, UK.
Frank SciurbaUniversity of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Marjorie StieglerGlaxoSmithKline, Research Triangle Park, NC, USA.
Chang-Qing ZhuGlaxoSmithKline, Stockley Park, Uxbridge, Middlesex, UK.
David BernsteinBernstein Clinical Research Center and Division of Immunology, Allergy and Rheumatology, University of Cincinnati College of Medicine, Cincinnati, OH, USA. bernstdd@ucmail.uc.edu.
GlaxoSmithKline (United Kingdom) · GBGlaxoSmithKline (United States) · USSpartanburg Regional Medical Center · USUniversity of Cincinnati · USUniversity of Leicester · GBUniversity of North Carolina at Chapel Hill · USUniversity of Pennsylvania · USUniversity of Pittsburgh Medical Center · US

Funding

GlaxoSmithKline N/A
6 · The paper itself

Abstract

backgroundThe comparative efficacy of inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β

methods207608 and 207609 were Phase IV, 12-week, randomized, double-blind, triple-dummy non-inferiority trials comparing once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 μg via Ellipta inhaler, with twice-daily budesonide/formoterol (BUD/FOR) 400/12 μg via metered-dose inhaler plus once-daily tiotropium (TIO) 18 μg via HandiHaler. Patients had symptomatic COPD and forced expiratory volume in 1 s (FEV

resultsThe modified per-protocol population included 720 and 711 patients in studies 207608 and 207609 (intent-to-treat population: 728 and 732). FF/UMEC/VI was non-inferior to BUD/FOR+TIO for wmCFB in 0-24-h FEV

conclusionsFF/UMEC/VI was non-inferior to BUD/FOR+TIO for wmCFB in 0-24-h FEV

trial registrationGSK (207608/207609; NCT03478683/NCT03478696).

Indexed as

Health StatusNebulizers and VaporizersAdministration, InhalationAgedAndrostadienesBronchodilator AgentsBudesonide, Formoterol Fumarate Drug CombinationDouble-Blind MethodDrug Administration ScheduleFemaleHumansLungMaleMiddle AgedPulmonary Disease, Chronic ObstructiveTreatment OutcomeAndrostadienesBronchodilator AgentsBudesonide, Formoterol Fumarate Drug Combinationfluticasone furoateCOPDInhaled corticosteroid (ICS)Long-acting muscarinic antagonist (LAMA)Long-acting β2-agonist (LABA)Lung functionSymptomsTriple therapy

Identifiers

PMID32471423
PMCPMC7257245
OpenAlexW3029577186

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.