Evidence map›Paper›PMID 28280319›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease2017

Umeclidinium/vilanterol as step-up therapy from tiotropium in patients with moderate COPD: a randomized, parallel-group, 12-week study.

Edward M Kerwin, Chris J Kalberg, Dmitry V Galkin, Chang-Qing Zhu, Alison Church, John H Riley, William A Fahy

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of chronic obstructive pulmonary disease, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01899742 (DB2116960), which is not on this map. Cited by 23 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 6 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.

NCT01899742 phase3completednot on this map

DB2116960: A Randomized, Double-Dummy, Parallel Group, Multicenter Trial Comparing the Efficacy and Safety of UMEC/VI (a Fixed Combination of Umeclidinium and Vilanterol) With Tiotropium In Subjects With COPD Who Continue To Have Symptoms on Tiotropium

TypeinterventionalSponsorGlaxoSmithKlineRan2014 to 2015Enrolled497ConditionsPulmonary Disease, Chronic ObstructiveArmsUmeclidinium/Vilanterol 62.5/25 mcg, Tiotropium 18 mcg
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
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  6. LABA/LAMA fixed-dose combinations in patients with COPD: a systematic review.International journal of chronic obstructive pulmonary disease
    Pooled it
  7. Trial
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  11. Article
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  13. Observational
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  17. Evidence-based review of data on the combination inhaler umeclidinium/vilanterol in patients with COPD.International journal of chronic obstructive pulmonary disease · 2019
    Review
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  19. 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

7 authors.

Edward M KerwinClinical Research Institute of Southern Oregon, Medford, OR.
Chris J KalbergRespiratory Department, GlaxoSmithKline, Research Triangle Park, NC, USA.
Dmitry V GalkinRespiratory Department, GlaxoSmithKline, Research Triangle Park, NC, USA.
Chang-Qing ZhuClinical Statistics, GlaxoSmithKline, Stockley Park, Uxbridge, Middlesex.
Alison ChurchRespiratory Department, GlaxoSmithKline, Research Triangle Park, NC, USA.
John H RileyRespiratory Department, GlaxoSmithKline, Stockley Park, Uxbridge, Middlesex, UK.
William A FahyRespiratory Department, GlaxoSmithKline, Stockley Park, Uxbridge, Middlesex, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPatients with COPD who remain symptomatic on long-acting bronchodilator monotherapy may benefit from step-up therapy to a long-acting bronchodilator combination. This study evaluated the efficacy and safety of umeclidinium (UMEC)/vilanterol (VI) in patients with moderate COPD who remained symptomatic on tiotropium (TIO).

methodsIn this randomized, blinded, double-dummy, parallel-group study (NCT01899742), patients (N=494) who were prescribed TIO for ≥3 months at screening (forced expiratory volume in 1 s [FEV

resultsCompared with TIO, UMEC/VI produced greater improvements in trough FEV

conclusionUMEC/VI step-up therapy provides clinical benefit over TIO monotherapy in patients with moderate COPD who are symptomatic on TIO alone.

Indexed as

AgedArgentinaBenzyl AlcoholsBronchodilator AgentsChlorobenzenesDrug SubstitutionEuropeFemaleForced Expiratory VolumeHumansIntention to Treat AnalysisLeast-Squares AnalysisLogistic ModelsLungMaleMiddle AgedBenzyl AlcoholsBronchodilator AgentsChlorobenzenesGSK573719Muscarinic AntagonistsQuinuclidinesTiotropium BromidevilanterolCOPDLABALAMAstep-uptiotropiumumeclidinium/vilanterol

Identifiers

PMID28280319
PMCPMC5338844

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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.