Evidence map›Paper›PMID 26286141›Full record

Trial reportBMC pulmonary medicine2015

Umeclidinium/vilanterol versus fluticasone propionate/salmeterol in COPD: a randomised trial.

Dave Singh, Sally Worsley, Chang-Qing Zhu, Liz Hardaker, Alison Church

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

Trial report in BMC pulmonary medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01822899 (DB2116134), which is not on this map. Cited by 31 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 15 pooled it
9.1field-weighted citation impact, top 2% 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.

NCT01822899 phase3completednot on this map

DB2116134: A Randomized, Multi-center, Double-blind, Double-dummy, Parallel Group Study to Evaluate the Efficacy and Safety of Umeclidinium Bromide/Vilanterol Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks in Subjects With COPD

TypeinterventionalSponsorGlaxoSmithKlineRan2013 to 2013Enrolled717ConditionsPulmonary Disease, Chronic ObstructiveArmsUmeclidinium bromide/Vilanterol, Placebo ACCUHALER/DISKUS, Fluticasone propionate/Salmeterol, Placebo NDPI
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 15 syntheses or guidelines pooled it, 62 citations in OpenAlex.

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  14. LABA/LAMA fixed-dose combinations in patients with COPD: a systematic review.International journal of chronic obstructive pulmonary disease
    Pooled it
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  16. Trial
  17. A randomized trial of symptom-based management in Japanese patients with COPD.International journal of chronic obstructive pulmonary disease · 2018
    Trial
  18. Observational
  19. Review
  20. The contribution of FEVPhysiological reports · 2020
    Article
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

5 authors at 2 institutions in 2 countries.

Dave SinghUniversity of Manchester, Medicines Evaluation Unit, Langley Building, University Hospital of South Manchester Foundations Trust, Southmoor Road, Manchester, M23 9QZ, UK. dsingh@meu.org.uk.
Sally WorsleyRespiratory Medicines Development Centre, GSK, London, UK. sally.d.worsley@gsk.com.
Chang-Qing ZhuQuantitative Sciences Division, GSK, London, UK. chang-qing.2.zhu@gsk.com.
Liz HardakerGlobal Clinical Safety and Pharmacovigilance, GSK, London, UK. liz.x.hardaker@gsk.com.
Alison ChurchRespiratory Medicines Development Center, GSK, Research Triangle Park, North Carolina, USA. alison.x.church@gsk.com.
Medicines Evaluation Unit · GBResearch Triangle Park Foundation · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUmeclidinium (UMEC; long-acting muscarinic antagonist) plus vilanterol (VI; long-acting beta2 agonist [LABA]) and the LABA/inhaled corticosteroid fluticasone propionate/salmeterol (FP/SAL) are approved maintenance treatments for chronic obstructive pulmonary disease (COPD). This 12-week, multicentre, double-blind, parallel-group, double-dummy study compared the efficacy and safety of these treatments in symptomatic patients with moderate-to-severe COPD with no exacerbations in the year prior to enrolment.

methodsPatients (n = 717) were randomised 1:1 to once-daily UMEC/VI 62.5/25 mcg or twice-daily FP/SAL 500/50 mcg. Endpoints included 0-24 h weighted mean (wm) forced expiratory volume in 1 s (FEV1) (Day 84; primary), trough FEV1 (Day 85; secondary), other lung function endpoints, symptoms, quality of life (QoL) and safety.

resultsImprovements with UMEC/VI versus FP/SAL were 0.080 L (95 % confidence interval: 0.046-0.113; wmFEV1) and 0.090 L (0.055-0.125; trough FEV1) (both p < 0.001). UMEC/VI statistically significantly improved all other lung function measures versus FP/SAL. Both treatments demonstrated a clinically meaningful improvement in symptoms (Transition Dyspnoea Index ≥1 unit) and QoL (St George's Respiratory Questionnaire Total score ≥4 unit decrease from baseline) over 12 weeks. The incidence of adverse events was 28 % (UMEC/VI) and 29 % (FP/SAL); nasopharyngitis and headache were most common.

conclusionsOnce-daily UMEC/VI 62.5/25 mcg over 12 weeks resulted in significant and sustained improvements in lung function versus twice-daily FP/SAL 500/50 mcg in patients with moderate-to-severe COPD and with no exacerbations in the year prior to enrolment.

trial registrationNCT01822899 Registration date: March 28, 2013.

Indexed as

Administration, InhalationAdultBronchodilator AgentsDouble-Blind MethodFemaleFluticasone-Salmeterol Drug CombinationFollow-Up StudiesForced Expiratory VolumeHumansMaleMiddle AgedPulmonary Disease, Chronic ObstructiveQuinuclidinesTreatment OutcomeBronchodilator AgentsFluticasone-Salmeterol Drug CombinationGSK573719Quinuclidines

Identifiers

PMID26286141
PMCPMC4545560
OpenAlexW2163317499

What OpenQuestion holds

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LicenceCC BY
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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.