Evidence map›Paper›PMID 27796912›Full record

Trial reportAdvances in therapy2017

Assessing Short-term Deterioration in Maintenance-naïve Patients with COPD Receiving Umeclidinium/Vilanterol and Tiotropium: A Pooled Analysis of Three Randomized Trials.

M Reza Maleki-Yazdi, Dave Singh, Antonio Anzueto, Lee Tombs, William A Fahy, Ian Naya

3 registry-linked trialsAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Advances in therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 33 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 3 pooled it
–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.

NCT01316900 phase3completednot on this map

A Multicenter Trial Comparing the Efficacy and Safety of GSK573719/GW642444 With GW642444 and With Tiotropium Over 24 Weeks in Subjects With COPD

TypeinterventionalSponsorGlaxoSmithKlineRan2011 to 2012Enrolled846ConditionsPulmonary Disease, Chronic ObstructiveArmsGSK573719/GW642444 125/25, GSK573719/GW642444 62.5/25, GW642444, tiotropium bromide
NCT01316913 phase3completednot on this map

A Multi-center Trial Comparing the Efficacy and Safety of GSK573719/GW642444 With GSK573719 and With Tiotropium Over 24 Weeks in Subjects With COPD

TypeinterventionalSponsorGlaxoSmithKlineRan2011 to 2012Enrolled872ConditionsPulmonary Disease, Chronic ObstructiveArmsGSK573719/GW642444 125/25, GSK573719/GW642444 62.5/25, GSK573719, tiotropium bromide
NCT01777334 phase3completednot on this map

A Multicenter, Trial Comparing the Efficacy and Safety of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily With Tiotropium 18 mcg Once Daily Over 24 Weeks in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

TypeinterventionalSponsorGlaxoSmithKlineRan2013 to 2013Enrolled905ConditionsPulmonary Disease, Chronic ObstructiveArmsUmeclidinium/Vilanterol 62.5/25 mcg, Tiotropium 18 mcg
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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  19. Future concepts in bronchodilation for COPD: dual-European respiratory review : an official journal of the European Respiratory Society · 2021
    Review
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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

6 authors.

M Reza Maleki-YazdiDivision of Respiratory Medicine, Women's College Hospital, University of Toronto, Toronto, ON, Canada. maleki.pccrc@on.aibn.com.
Dave SinghMedicines Evaluation Unit, University of Manchester, University Hospital of South Manchester Foundation Trust, Manchester, UK.
Antonio AnzuetoSouth Texas Veterans Health Care System, Audie L. Murphy Hospital, and University of Texas Health Science Center, San Antonio, TX, USA.
Lee TombsPrecise Approach LTD, Birmingham, UK.
William A FahyGSK, Respiratory Medicines Development Centre, Stockley Park, Middlesex, UK.
Ian NayaGSK, Respiratory Medicines Development Centre, Stockley Park, Middlesex, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDual bronchodilator therapy is reserved as a second-line treatment in patients with chronic obstructive pulmonary disease (COPD) and provides benefits in lung function and health status versus monotherapy. The aim of this study was to determine whether early initiation of a dual bronchodilator versus monotherapy reduced the risk of deterioration in COPD.

methodsThis post hoc pooled analysis investigated the efficacy and safety of umeclidinium/vilanterol (UMEC/VI) 62.5/25 mcg/day compared with tiotropium (TIO) 18 mcg/day in a maintenance-naïve (MN) subgroup of patients relative to the intent-to-treat (ITT) population from three 6-month active comparator studies (n = 1747). Other treatment arms (UMEC/VI 125/25, VI 25 and UMEC 125) comprised 850 patients in total but were not included in this analysis. The primary endpoint was trough forced expiratory volume in 1 s (FEV

resultsUMEC/VI improved trough FEV

conclusionsEarly use of dual-bronchodilator therapy has superior efficacy on lung function and may reduce the risk of short-term deterioration compared to monotherapy in symptomatic patients with COPD. CLINICAL

trial registrationGSK analysis 202066 (NCT01316900/DB2113360, NCT01316913/DB2113374, NCT01777334/ZEP117115).

fundingThis study was funded by GSK.

Indexed as

Administration, InhalationAgedAged, 80 and overBenzyl AlcoholsBronchodilator AgentsChlorobenzenesDouble-Blind MethodFemaleForced Expiratory VolumeHumansMaleMiddle AgedPulmonary Disease, Chronic ObstructiveQuinuclidinesTiotropium BromideTreatment OutcomeBenzyl AlcoholsBronchodilator AgentsChlorobenzenesQuinuclidinesTiotropium BromidevilanterolChronic obstructive pulmonary diseaseClinically important deteriorationRespiratoryUmeclidiniumVilanterol

Identifiers

PMID27796912
PMCPMC5126189

What OpenQuestion holds

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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.