Evidence map›Paper›PMID 30191464›Full record

ArticleAdvances in therapy2018

Preventing Clinically Important Deterioration of COPD with Addition of Umeclidinium to Inhaled Corticosteroid/Long-Acting β

Ian P Naya, Lee Tombs, David A Lipson, Chris Compton

4 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in Advances in therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 15% 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.

NCT01772134 phase3completednot on this map

A Multicenter, Randomized, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of the Addition of Umeclidinium Bromide (62.5mcg) Once-daily to Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily, Umeclidinium Bromide (125mcg) Once-daily to Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily Versus Placebo to Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily Over 12 Weeks With COPD

TypeinterventionalSponsorGlaxoSmithKlineRan2013 to 2013Enrolled617ConditionsPulmonary Disease, Chronic ObstructiveArmsUmeclidinium bromide 62.5mcg, Umeclidinium bromide 125mcg, Fluticasone propionate 250mcg/Salmeterol 50mcg, Placebo
NCT01772147 phase3completednot on this map

A Multicenter, Randomized, Double-blind, Parallelgroup Study to Evaluate the Efficacy and Safety of the Addition of Umeclidinium Bromide Inhalation Powder (62.5mcg) Once-daily to Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily, Umeclidinium Bromide Inhalation Powder (125mcg) Once-daily to Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily Versus Placebo to Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily Over 12 Weeks in Subjects With COPD.

TypeinterventionalSponsorGlaxoSmithKlineRan2013 to 2013Enrolled608ConditionsPulmonary Disease, Chronic ObstructiveArmsUmeclidinium bromide 62.5mcg, Umeclidinium bromide 125mcg, Fluticasone propionate 250mcg/Salmeterol 50mcg
NCT01957163 phase3completednot on this map

A Study to Compare the Addition of Umeclidinium Bromide (UMEC) to Fluticasone Furoate (FF)/Vilanterol (VI), With Placebo Plus FF/VI in Subjects With Chronic Obstructive Pulmonary Disease (COPD) -Study 1

TypeinterventionalSponsorGlaxoSmithKlineRan2013 to 2014Enrolled619ConditionsPulmonary Disease, Chronic ObstructiveArmsFF, VI, UMEC, Placebo
NCT02119286 phase3completednot on this map

A Study to Compare the Addition of Umeclidinium Bromide (UMEC) to Fluticasone Furoate (FF)/Vilanterol (VI), With Placebo Plus FF/VI in Subjects With Chronic Obstructive Pulmonary Disease (COPD) -Study 2

TypeinterventionalSponsorGlaxoSmithKlineRan2013 to 2014Enrolled620ConditionsPulmonary Disease, Chronic ObstructiveArmsFF, VI, UMEC, Placebo
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 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

4 authors at 1 institution in 1 country.

Ian P NayaGlobal Respiratory Franchise, GSK, Brentford, Middlesex, UK. ian.p.naya@gsk.com.
Lee TombsPrecise Approach Ltd., Stockley Park West, Uxbridge, Middlesex, UK.
David A LipsonRespiratory Clinical Development, GSK, Collegeville, PA, USA.
Chris ComptonGlobal Respiratory Franchise, GSK, Brentford, Middlesex, UK.
GlaxoSmithKline (United States) · US

Funding

GSK 202067
6 · The paper itself

Abstract

introductionAssessing clinically important measures of disease progression is essential for evaluating therapeutic effects on disease stability in chronic obstructive pulmonary disease (COPD). This analysis assessed whether providing additional bronchodilation with the long-acting muscarinic antagonist umeclidinium (UMEC) to patients treated with inhaled corticosteroid (ICS)/long-acting β

methodsThis integrated post hoc analysis of four 12-week, randomized, double-blind trials (NCT01772134, NCT01772147, NCT01957163, NCT02119286) compared UMEC 62.5 µg with placebo added to open-label ICS/LABA in symptomatic patients with COPD (modified Medical Research Council dyspnea scale score ≥ 2). A clinically important deterioration (CID) was defined as: a decrease from baseline of ≥ 100 mL in trough forced expiratory volume in 1 s (FEV

resultsOverall, 1637 patients included in the ITT population received UMEC + ICS/LABA (n = 819) or placebo + ICS/LABA (n = 818). Additional bronchodilation with UMEC reduced the risk of a first CID by 45-58% in the ITT population and all subgroups analyzed compared with placebo (all p < 0.001). Improvements were observed in reducing FEV

conclusionSymptomatic patients with COPD receiving ICS/LABA experience frequent deteriorations. Additional bronchodilation with UMEC significantly reduced the risk of CID and provided greater short-term stability versus continued ICS/LABA therapy in these patients.

fundingGlaxoSmithKline (study number: 202067). Plain language summary available for this article.

Indexed as

Benzyl AlcoholsChlorobenzenesFluticasone-Salmeterol Drug CombinationPulmonary Disease, Chronic ObstructiveQuinuclidinesAgedDisease ProgressionDouble-Blind MethodFemaleForced Expiratory VolumeHumansMaleMiddle AgedMuscarinic AntagonistsRandomized Controlled Trials as TopicRespiratory System AgentsBenzyl AlcoholsChlorobenzenesFluticasone-Salmeterol Drug CombinationGSK573719Muscarinic AntagonistsQuinuclidinesRespiratory System AgentsvilanterolAdd-on LAMAClinically important deteriorationsCOPDFluticasone furoate/vilanterolFluticasone propionate/salmeterolRespiratoryTriple therapyUmeclidinium

Identifiers

PMID30191464
PMCPMC6182634
OpenAlexW2891291416

What OpenQuestion holds

Textmetadata
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.