Evidence map›Paper›PMID 32532275›Full record

Trial reportRespiratory research2020

A phase IIb, randomised, parallel-group study: the efficacy, safety and tolerability of once-daily umeclidinium in patients with asthma receiving inhaled corticosteroids.

Edward Kerwin, Steven Pascoe, Zelie Bailes, Robert Nathan, David Bernstein, Ronald Dahl, Robyn von Maltzahn, Kevin Robbins, Andrew Fowler, Laurie Lee

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Respiratory research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 20% 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.

NCT03012061 phase2completednot on this map

A Phase IIb, 24 Week, Randomized, Double-blind, 3 Arm Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of Two Doses of Umeclidinium Bromide Administered Once-daily Via a Dry Powder Inhaler, Versus Placebo, in Participants With Asthma

TypeinterventionalSponsorGlaxoSmithKlineRan2017 to 2018Enrolled425ConditionsAsthmaArmsPlacebo, UMEC, Fluticasone Furoate, Albuterol/salbutamol
NCT04651777 phase3active not recruitingnot on this mapstarted 2022, after this paper: background citation

Evaluation of Triple Therapy Using Magnetic Resonance Imaging in Asthma

TypeinterventionalSponsorDr. Grace ParragaRan2022 to 2025Enrolled31ConditionsAsthmaArmsFF/UMEC/VI
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Home Spirometry in Children with Cystic Fibrosis.Bioengineering (Basel, Switzerland) · 2023
    Article
  4. Article
  5. 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

10 authors at 4 institutions in 2 countries.

Edward KerwinCrisor LLC Research, Clinical Research Institute of Southern Oregon, Medford, OR, USA.
Steven PascoeGSK, Upper Providence, PA, USA.
Zelie BailesGSK, Stockley Park West, Uxbridge, Middlesex, UK.
Robert NathanAsthma & Allergy Associates, P.C. and Research Center, Colorado Springs, CO, USA.
David BernsteinDivision of Immunology, Allergy and Rheumatology, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
Ronald DahlGSK, 980 Great West Road, Brentford, Middlesex, UK.
Robyn von MaltzahnGSK, Stockley Park West, Uxbridge, Middlesex, UK.
Kevin RobbinsGSK, Upper Providence, PA, USA.
Andrew FowlerGSK, Stockley Park West, Uxbridge, Middlesex, UK.
Laurie LeeGSK, Upper Providence, PA, USA. laurie.myers.lee@gmail.com.
Providence College · USBernstein Clinical Research Center · USClinical Research Institute · USWest Middlesex University Hospital · GB

Funding

GlaxoSmithKline n/a
6 · The paper itself

Abstract

backgroundPatients with asthma uncontrolled on inhaled corticosteroids may benefit from umeclidinium (UMEC), a long-acting muscarinic antagonist.

methodsThis Phase IIb, double-blind study included patients with reversible, uncontrolled/partially-controlled asthma for ≥6 months, receiving ≥100 mcg/day fluticasone propionate (or equivalent) for ≥12 weeks. Following a 2-week run-in on open-label fluticasone furoate (FF) 100 mcg, patients were randomised (1:1:1) to receive UMEC 31.25 mcg, UMEC 62.5 mcg or placebo on top of FF 100 mcg once-daily for 24 weeks. As-needed salbutamol was provided. Primary and secondary endpoints were change from baseline in clinic trough forced expiratory volume in 1 s (FEV

resultsThe intent-to-treat population comprised 421 patients (UMEC 31.25 mcg: n =139, UMEC 62.5 mcg: n =139, placebo: n =143). UMEC 31.25 mcg and 62.5 mcg demonstrated significantly greater improvements from baseline in clinic trough FEV

conclusionsUMEC is a highly effective bronchodilator that leads to improved lung function when administered as a single bronchodilator on top of FF in subjects with fully reversible, uncontrolled/partially-controlled moderate asthma. These data support a favourable benefit/risk profile for UMEC (31.25 mcg and 62.5 mcg).

trial registrationGSK study ID: 205832; Clinicaltrials.gov ID: NCT03012061.

Indexed as

Drug ToleranceAdministration, InhalationAsthmaBronchodilator AgentsDouble-Blind MethodDrug Therapy, CombinationFemaleFluticasoneForced Expiratory VolumeGlucocorticoidsHumansMaleMiddle AgedQuinuclidinesTreatment OutcomeBronchodilator AgentsFluticasoneGlucocorticoidsGSK573719QuinuclidinesAsthmaForced expiratory volume in 1 sInhaled corticosteroidLong-acting muscarinic antagonistUmeclidinium

Identifiers

PMID32532275
PMCPMC7291639
OpenAlexW3035246543

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.