Evidence map›Paper›PMID 29313286›Full record

Trial reportAdvances in therapy2018

Once-Daily Triple Therapy in Patients with COPD: Patient-Reported Symptoms and Quality of Life.

Maggie Tabberer, David A Lomas, Ruby Birk, Noushin Brealey, Chang-Qing Zhu, Steve Pascoe, Nicholas Locantore, David A Lipson

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report 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 trial NCT02345161 (A Phase III, 24 Week, Randomized, Double Blind, Double Dummy, Parallel Group Study), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
4.4field-weighted citation impact, top 5% 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.

NCT02345161 phase3completednot on this map

A Phase III, 24 Week, Randomized, Double Blind, Double Dummy, Parallel Group Study (With an Extension to 52 Weeks in a Subset of Subjects) Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination FF/UMEC/VI Administered Once Daily in the Morning Via a Dry Powder Inhaler With Budesonide/Formoterol 400mcg/12mcg Administered Twice-Daily Via a Reservoir Inhaler in Subjects With Chronic Obstructive Pulmonary Disease

TypeinterventionalSponsorGlaxoSmithKlineRan2015 to 2016Enrolled1,811ConditionsPulmonary Disease, Chronic ObstructiveArmsTriple FF/UMEC/VI, Placebo to match FF/UMEC/VI, Budesonide/Formoterol, Placebo to match Budesonide/Formoterol combination, Albuterol/salbutamol
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 32 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Relationship Between Clinical Control, Respiratory Symptoms and Quality of Life for Patients with COPD.International journal of chronic obstructive pulmonary disease · 2020
    Observational
  12. Review
  13. Review
  14. Symptomatic burden of COPD for patients receiving dual or triple therapy.International journal of chronic obstructive pulmonary disease
    Observational
  15. Observational
  16. Observational
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

8 authors at 4 institutions in 2 countries.

Maggie TabbererValue Evidence and Outcomes, GSK, Stockley Park, UK. margaret.x.tabberer@gsk.com.
David A LomasUCL Respiratory, University College London, London, UK.
Ruby BirkRespiratory Clinical Development, GSK, Stockley Park, UK.
Noushin BrealeyRespiratory Clinical Development, GSK, Stockley Park, UK.
Chang-Qing ZhuClinical Statistics, GSK, Stockley Park, UK.
Steve PascoeRespiratory Research and Development, GSK, King of Prussia, PA, USA.
Nicholas LocantoreRespiratory Research and Development, GSK, King of Prussia, PA, USA.
David A LipsonRespiratory Research and Development, GSK, King of Prussia, PA, USA.
Frimley Park Hospital · GBHealth Economics and Outcomes Research (United Kingdom) · GBUniversity College London · GBUniversity of Pennsylvania · US

Funding

GSK CTT116853Medical Research Council MR/N024842/1
6 · The paper itself

Abstract

introductionDirectly recorded patient experience of symptoms and health-related quality of life (HRQoL) can complement lung function and exacerbation rate data in chronic obstructive pulmonary disease (COPD) clinical studies. The FULFIL study recorded daily symptoms and activity limitation together with additional patient-reported outcomes of dyspnea and HRQoL, as part of the prespecified analyses. FULFIL co-primary endpoint data have been previously reported.

methodsFULFIL was a phase III, 24-week, randomized, double-blind, double-dummy, multicenter study comparing once-daily single inhaler triple therapy [fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI)] 100 µg/62.5 µg/25 µg with twice-daily inhaled corticosteroid/long-acting β

resultsFF/UMEC/VI showed greater reductions from baseline in 4-weekly mean E-RS: COPD total and all subscale scores compared with BUD/FOR; differences were statistically significant (P < 0.05) at each time period. FF/UMEC/VI also demonstrated greater improvements from baseline at weeks 4 and 24 in SGRQ domain scores and TDI focal score compared with BUD/FOR. At weeks 4 and 24, improvements greater than the minimal clinically important difference from baseline were observed in CAT score with FF/UMEC/VI, but not BUD/FOR; differences were statistically significant (P ≤ 0.003).

conclusionThese findings demonstrate sustained daily symptom and HRQoL benefits of FF/UMEC/VI versus BUD/FOR. The inclusion of the CAT may provide data that are readily generalizable to everyday clinical practice.

trial registrationClinicalTrials.gov number: NCT02345161.

fundingGSK.

Indexed as

Administration, InhalationAdultBenzyl AlcoholsBronchodilator AgentsBudesonide, Formoterol Fumarate Drug CombinationChlorobenzenesDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationDyspneaFemaleFluticasoneForced Expiratory VolumeHumansMaleMiddle AgedBenzyl AlcoholsBronchodilator AgentsBudesonide, Formoterol Fumarate Drug CombinationChlorobenzenesFluticasoneGSK573719QuinuclidinesvilanterolBudesonide/formoterolCOPD burdenFluticasone furoate/umeclidinium/vilanterolPatient-reported outcomesRespiratorySymptom burden

Identifiers

PMID29313286
PMCPMC5778187
OpenAlexW2783252549

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.