Evidence map›Paper›PMID 32647911›Full record

ArticleAdvances in therapy2020

Single-Inhaler Triple Therapy and Health-Related Quality of Life in COPD: The IMPACT Study.

Maggie Tabberer, C Elaine Jones, Sally Kilbride, David M G Halpin, David A Lomas, Steven Pascoe, Dave Singh, Robert A Wise, Gerard J Criner, Peter Lange and 5 more

Erratum issued Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in Advances in therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02164513 (A Phase III, 52 Week, Randomized, Double-blind, 3-arm Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination FF/UMEC/VI With the Fixed Dose Dual Combinations of FF/VI and UMEC/VI, All Administered Once-daily in the Morning Via a Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.3field-weighted citation impact, top 17% 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.

NCT02164513 phase3completednot on this map

A Phase III, 52 Week, Randomized, Double-blind, 3-arm Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination FF/UMEC/VI With the Fixed Dose Dual Combinations of FF/VI and UMEC/VI, All Administered Once-daily in the Morning Via a Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease

TypeinterventionalSponsorGlaxoSmithKlineRan2014 to 2017Enrolled10,355ConditionsPulmonary Disease, Chronic ObstructiveArmsfluticasone furoate (FF), vilanterol (VI), umeclidinium bromide (UMEC)
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 16 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 13 institutions in 3 countries.

Maggie TabbererGlaxoSmithKline plc, Stockley Park West, Uxbridge, Middlesex, UK. margaret.x.tabberer@gsk.com.
C Elaine JonesGlaxoSmithKline plc, Research Triangle Park, NC, USA.
Sally KilbrideGlaxoSmithKline plc, Stockley Park West, Uxbridge, Middlesex, UK.
David M G HalpinUniversity of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, UK.
David A LomasUCL Respiratory, University College London, London, UK.
Steven PascoeGlaxoSmithKline plc, Collegeville, PA, USA.
Dave SinghThe Centre for Respiratory Medicine and Allergy, Institute of Inflammation and Repair, Manchester Academic Health Science Centre, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.
Robert A WiseThe Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Gerard J CrinerLewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.
Peter LangeUniversity of Copenhagen, Copenhagen, Denmark.
Mark T DransfieldThe Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, AL, USA.
MeiLan K HanUniversity of Michigan, Pulmonary and Critical Care, Ann Arbor, MI, USA.
Fernando J MartinezNew York-Presbyterian Hospital/Weill Cornell Medical Center, New York, NY, USA.
Morrys C KaisermannGlaxoSmithKline plc, Collegeville, PA, USA.
David A LipsonGlaxoSmithKline plc, Collegeville, PA, USA.
GlaxoSmithKline (United Kingdom) · GBGlaxoSmithKline (United States) · USCornell University · USJohns Hopkins Medicine · USManchester University NHS Foundation Trust · GBResearch Triangle Park Foundation · USTemple University · USUniversity College London · GBUniversity of Alabama at Birmingham · USUniversity of Copenhagen · DKUniversity of Exeter · GBUniversity of Michigan–Ann Arbor · USUniversity of Pennsylvania · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe phase 3 InforMing the PAthway of COPD (chronic obstructive pulmonary disease) Treatment (IMPACT) trial, single-inhaler therapy with fluticasone furoate (FF) 100 μg, umeclidinium (UMEC) 62.5 μg, and vilanterol (VI) 25 μg demonstrated a reduction in the rate of moderate or severe exacerbations compared with FF/VI or UMEC/VI in patients with symptomatic COPD at risk of exacerbations. This article reports additional evidence of improvements in symptoms and health-related quality of life (HRQoL) with FF/UMEC/VI compared with either FF/VI or UMEC/VI from the IMPACT study.

methodsPatient-reported HRQoL assessments and symptom measures included as pre-specified IMPACT end points were the St George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT), and Baseline Dyspnea Index (BDI) as the anchor for the Transitional Dyspnea Index (TDI) focal score (BDI/TDI) in a subset of patients enrolled at study sites in North America and Europe. Change from baseline was assessed at weeks 4, 28, and 52.

resultsThe intent-to-treat population included 10,355 patients (TDI population: 5058 patients). Clinically meaningful improvements in SGRQ total score between baseline and week 52 favored FF/UMEC/VI over FF/VI (- 1.8 units, p < 0.001) and UMEC/VI (- 1.8 units, p < 0.001). Similar improvements in the CAT and TDI focal score were also observed with FF/UMEC/VI versus FF/VI or UMEC/VI.

conclusionsThis study demonstrates that in patients with symptomatic COPD at risk of exacerbations, once-daily FF/UMEC/VI, compared with FF/VI or UMEC/VI, improves patient-perceived HRQoL and symptoms. TRIAL REGISTRATION NUMBER: NCT02164513.

Indexed as

Administration, InhalationAdultAgedAged, 80 and overAndrostadienesBenzyl AlcoholsBronchodilator AgentsChlorobenzenesFemaleHumansMaleMiddle AgedNebulizers and VaporizersPulmonary Disease, Chronic ObstructiveQuality of LifeQuinuclidinesAndrostadienesBenzyl AlcoholsBronchodilator AgentsChlorobenzenesQuinuclidinesCOPDExacerbationsHealth-related quality of lifeIMPACT trialPatient-reported outcomesSingle-inhaler triple therapy

Identifiers

PMID32647911
PMCPMC7444357
OpenAlexW3040902964

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.