Evidence map›Paper›PMID 34972260›Full record

ArticleChronic obstructive pulmonary diseases (Miami, Fla.)2022

Higher COPD Assessment Test Score Associated With Greater Exacerbations Risk: A Post Hoc Analysis of the IMPACT Trial.

Byron Thomashow, Marjorie Stiegler, Gerard J Criner, Mark T Dransfield, David M G Halpin, MeiLan K Han, Peter Lange, Fernando J Martinez, Dawn Midwinter, Dave Singh and 4 more

Registry-linked trialOpen access · diamondAbstract read
In one paragraph

Article in Chronic obstructive pulmonary diseases (Miami, Fla.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. 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
1.0field-weighted citation impact, top 21% 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, 12 citations in OpenAlex.

  1. Article
  2. Article
  3. Exacerbations of COPD.Respiratory care · 2023
    Article
  4. Article
  5. Article
  6. 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

14 authors at 12 institutions in 3 countries.

Byron ThomashowDivision of Pulmonary, Allergy, and Critical Care, Columbia University Medical Center, New York, New York, United States.
Marjorie StieglerUniversity of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, United States.
Gerard J CrinerLewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania, United States.
Mark T DransfieldLung Health Center, Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama at Birmingham, Birmingham, Alabama, United States.
David M G HalpinUniversity of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, United Kingdom.
MeiLan K HanPulmonary and Critical Care, University of Michigan, Ann Arbor, Michigan, United States.
Peter LangeSection of Epidemiology, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.
Fernando J MartinezWeill Cornell Medicine, New York, New York, United States.
Dawn MidwinterGlaxoSmithKline, Brentford, Middlesex, United Kingdom.
Dave SinghCentre for Respiratory Medicine and Allergy, Institute of Inflammation and Repair, Manchester Academic Health Science Centre, University of Manchester, Manchester University NHS Foundation Trust, Manchester, United Kingdom.
Maggie TabbererGlaxoSmithKline, Brentford, Middlesex, United Kingdom.
Robert A WiseDivision of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States.
David A LipsonGlaxoSmithKline, Collegeville, Pennsylvania, United States.
Paul JonesGlaxoSmithKline, Brentford, Middlesex, United Kingdom.
GlaxoSmithKline (United Kingdom) · GBColumbia University Irving Medical Center · USCornell University · USGentofte Hospital · DKGlaxoSmithKline (United States) · USJohns Hopkins University · USManchester Academic Health Science Centre · GBResearch Triangle Park Foundation · USTemple University · USUniversity of Alabama at Birmingham · USUniversity of Exeter · GBUniversity of Michigan–Ann Arbor · US

Funding

GlaxoSmithKline CTT116855GlaxoSmithKline NCT02164513
6 · The paper itself

Abstract

backgroundIn the InforMing the PAthway of COPD Treatment (IMPACT) trial, single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) reduced moderate/severe exacerbation rates versus FF/VI and UMEC/VI in patients with chronic obstructive pulmonary disease (COPD). This post hoc analysis tested the relationship between baseline health status, risk of future exacerbations, and efficacy outcomes.

methodsIMPACT was a Phase 3, double-blind, 52-week trial in patients with symptomatic COPD (COPD Assessment Test [CAT] score ≥10) and ≥1 moderate/severe exacerbation in the prior year randomized 2:2:1 to FF/UMEC/VI 100/62.5/25mcg, FF/VI 100/25mcg, or UMEC/VI 62.5/25mcg. Annual rate of on-treatment moderate/severe exacerbations, lung function, and safety were analyzed by continuous baseline CAT score.

resultsModerate/severe exacerbation rates increased with increasing baseline CAT scores in FF/UMEC/VI and UMEC/VI arms. There was a very small increase in on-treatment pneumonia rates at higher baseline CAT scores across all treatment arms. FF/UMEC/VI reduced moderate/severe exacerbation rates versus UMEC/VI (i.e., the inhaled corticosteroid effect) consistently across the range of CAT scores. The reduction with FF/UMEC/VI versus FF/VI (i.e., the long-acting muscarinic antagonist effect) was greatest at lower CAT scores and appeared lesser at higher CAT scores. Improvements in lung function were observed with FF/UMEC/VI versus FF/VI and UMEC/VI, regardless of baseline CAT score.

conclusionsThe CAT score was predictive of exacerbation risk. Worse baseline health status was associated with higher moderate/severe exacerbation and pneumonia rates. Irrespective of baseline CAT score, FF/UMEC/VI improved lung function, and reduced the annual moderate/severe exacerbation rates versus dual therapy. Results indicate an overall favorable benefit-risk profile of triple versus dual therapy, irrespective of CAT score. Clinical Trial Registration:GSK (CTT116855/NCT02164513).

Indexed as

COPD Assessment TestexacerbationsIMPACT trialpatient-reported outcomessingle-inhaler triple therapy

Identifiers

PMID34972260
PMCPMC8893967
OpenAlexW4205350391

What OpenQuestion holds

Textmetadata
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.