Evidence map›Paper›PMID 29370819›Full record

Trial reportRespiratory research2018

Single-inhaler fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol plus umeclidinium using two inhalers for chronic obstructive pulmonary disease: a randomized non-inferiority study.

Peter R Bremner, Ruby Birk, Noushin Brealey, Afisi S Ismaila, Chang-Qing Zhu, David A Lipson

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Respiratory research, 2018. 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 25 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 6 pooled it
6.6field-weighted citation impact, top 3% 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.

NCT02729051 phase3completednot on this map

A Phase IIIB, 24-week Randomised, Double-blind Study to Compare 'Closed' Triple Therapy (FF/UMEC/VI) With 'Open' Triple Therapy (FF/VI + UMEC), in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

TypeinterventionalSponsorGlaxoSmithKlineRan2016 to 2017Enrolled1,055ConditionsPulmonary Disease, Chronic ObstructiveArmsFF/UMEC/VI, FF/VI, UMEC, Placebo, Albuterol/salbutamol
NCT06905483 phase4completednot on this mapstarted 2025, after this paper: background citation

Comparative Effects of Triple Inhaled Therapy With Budesonide/Glycopyrronium/Formoterol Versus Fluticasone Furoate/Umeclidinium/Vilanterol on Small Airway Disease in COPD Patients: A Randomized Crossover Study

TypeinterventionalSponsorThammasat UniversityRan2025 to 2026Enrolled22ConditionsCOPD, Chronic Obstructive Pulmonary Disease (COPD), Small Airway Disease, Triple TherapyArmsBudesonide/Glycopyrronium/Formoterol (BGF), Fluticasone Furoate/Umeclidinium/Vilanterol (FUV)
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 6 syntheses or guidelines pooled it, 57 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
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  5. Pooled it
  6. Pooled it
  7. Trial
  8. Effect of background long-acting betaInternational journal of chronic obstructive pulmonary disease
    Trial
  9. Observational
  10. Article
  11. Review
  12. Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Dual Bronchodilator in the Era of Triple Therapy.International journal of chronic obstructive pulmonary disease · 2020
    Review
  19. A Delphi Consensus Document on the Use of Single-Inhaler Fixed-Dose Triple Therapies in COPD Patients.International journal of chronic obstructive pulmonary disease · 2020
    Article
  20. COPD from an everyday primary care point of view.Journal of family medicine and primary care · 2019
    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

6 authors at 2 institutions in 3 countries.

Peter R BremnerUniversity of Notre Dame, Fremantle, WA, Australia.
Ruby BirkGSK, Stockley Park West, Uxbridge, Middlesex, UK.
Noushin BrealeyGSK, Stockley Park West, Uxbridge, Middlesex, UK.
Afisi S IsmailaGSK, Collegeville, PA, USA.
Chang-Qing ZhuGSK, Stockley Park West, Uxbridge, Middlesex, UK.
David A LipsonGSK, 709 Swedeland Road, UW2531, King of Prussia, PA, 19406, USA. david.a.lipson@gsk.com.
Impact · CAThe University of Notre Dame Australia · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSingle-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 μg has been shown to improve lung function and health status, and reduce exacerbations, versus budesonide/formoterol in patients with chronic obstructive pulmonary disease (COPD). We evaluated the non-inferiority of single-inhaler FF/UMEC/VI versus FF/VI + UMEC using two inhalers.

methodsEligible patients with COPD (aged ≥40 years; ≥1 moderate/severe exacerbation in the 12 months before screening) were randomized (1:1; stratified by the number of long-acting bronchodilators [0, 1 or 2] per day during run-in) to receive 24-week FF/UMEC/VI 100/62.5/25 μg and placebo or FF/VI 100/25 μg + UMEC 62.5 μg; all treatments/placebo were delivered using the ELLIPTA inhaler once-daily in the morning. Primary endpoint: change from baseline in trough forced expiratory volume in 1 s (FEV

resultsA total of 1055 patients (844 [80%] of whom were enrolled on combination maintenance therapy) were randomized to receive FF/UMEC/VI (n = 527) or FF/VI + UMEC (n = 528). Mean change from baseline in trough FEV

conclusionsSingle-inhaler triple therapy (FF/UMEC/VI) is non-inferior to two inhalers (FF/VI + UMEC) on trough FEV

trial registrationGSK study CTT200812; ClinicalTrials.gov NCT02729051 (submitted 31 March 2016).

Indexed as

Administration, InhalationAgedAndrostadienesBenzyl AlcoholsBronchodilator AgentsChlorobenzenesDouble-Blind MethodFemaleHumansMaleMiddle AgedNebulizers and VaporizersPulmonary Disease, Chronic ObstructiveQuinuclidinesAndrostadienesBenzyl AlcoholsBronchodilator AgentsChlorobenzenesfluticasone furoateGSK573719QuinuclidinesvilanterolCOPDExacerbationsFEV1Fluticasone furoate/umeclidinium/vilanterolLung functionRandomized controlled trialSingle-inhaler triple therapy

Identifiers

PMID29370819
PMCPMC5785849
OpenAlexW2798219007

What OpenQuestion 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 OpenQuestion graph.