Evidence map›Paper›PMID 26730183›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease2016

Efficacy and safety of fluticasone furoate/vilanterol or tiotropium in subjects with COPD at cardiovascular risk.

Henry Covelli, Bonavuth Pek, Isabelle Schenkenberger, Catherine Scott-Wilson, Amanda Emmett, Courtney Crim

Open access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of chronic obstructive pulmonary disease, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 7 pooled it
2.6field-weighted citation impact, top 10% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 7 syntheses or guidelines pooled it, 52 citations in OpenAlex.

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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 at 5 institutions in 2 countries.

Henry CovelliKootenai Health, Coeur d'Alene, ID, USA.
Bonavuth PekClinique de Pneumologie et de Sommeil de Lanaudière, Quebec, Canada.
Isabelle SchenkenbergerKlinische Forschung, Berlin, Germany.
Catherine Scott-WilsonGlaxoSmithKline Inc., Research Triangle Park, Durham, NC, USA.
Amanda EmmettPAREXEL International, Durham, NC, USA.
Courtney CrimGlaxoSmithKline Inc., Research Triangle Park, Durham, NC, USA.
Gesellschaft für Klinische Forschung · DEGlaxoSmithKline (United States) · USKootenai Medical Center · USPAREXEL International (United States) · USResearch Triangle Park Foundation · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFluticasone furoate/vilanterol (FF/VI) is a novel, once-daily, inhaled corticosteroid/long-acting β2-agonist combination approved for the treatment of COPD and asthma. We compared the safety and efficacy of FF/VI and tiotropium (TIO) in subjects with moderate-to-severe COPD with greater risk for comorbid cardiovascular disease (CVD).

methodsThis randomized, blinded, double-dummy, parallel-group study compared a once-daily morning dose of FF/VI 100/25 mcg delivered via ELLIPTA™ with TIO 18 mcg via HandiHaler(®) for 12 weeks in subjects with diagnosed COPD, forced expiratory volume in 1 second (FEV1) 30%-70% predicted, and CVD or CVD risk. The primary endpoint was change from baseline in 24-hour weighted mean FEV1 on Day 84. Other efficacy endpoints included time to onset of bronchodilation, trough FEV1, other spirometry measures, rescue medication use, symptoms, quality of life (St George's Respiratory Questionnaire-COPD [SGRQ-C]), and health status (COPD Assessment Tests [CAT]) measures. Safety endpoints included cardiovascular monitoring, cortisol excretion, COPD exacerbations, and adverse events, including prespecified drug effects.

resultsBoth FF/VI and TIO improved the 24-hour weighted mean FEV1 from baseline after 12 weeks with no significant difference between treatments. Other endpoints favored FF/VI for time to onset of bronchodilation, rescue medication use, dyspnea, SGRQ-C and CAT scores, or favored TIO for change from baseline in forced vital capacity and inspiratory capacity. Pneumonia occurred more frequently in the FF/VI group, and two TIO-treated subjects died following cardiovascular events. Other safety measures were similar between groups, and cardiovascular monitoring did not reveal increased CVD risk.

conclusionBoth FF/VI and TIO were efficacious in improving lung function in subjects with COPD and comorbid CVD or CVD risk factors, with minor differences in efficacy and safety profiles.

Indexed as

AndrostadienesBenzyl AlcoholsChlorobenzenesPulmonary Disease, Chronic ObstructiveQuality of LifeTiotropium BromideAdministration, InhalationAdultAgedBronchodilator AgentsCardiovascular DiseasesDrug CombinationsDrug MonitoringFemaleForced Expiratory VolumeHumansAndrostadienesBenzyl AlcoholsBronchodilator AgentsChlorobenzenesDrug Combinationsfluticasone furoateTiotropium Bromidevilanterolanticholinergiccardiovascular diseaseCOPDfluticasone furoate/vilanterolICS/LABAtiotropium

Identifiers

PMID26730183
PMCPMC4694692
OpenAlexW2202263951

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.