Evidence map›Paper›PMID 30019939›Full record

Trial reportAmerican journal of respiratory and critical care medicine2019

Capturing Exacerbations of Chronic Obstructive Pulmonary Disease with EXACT. A Subanalysis of FLAME.

Stefan M Frent, Kenneth R Chapman, Michael Larbig, Alexander Mackay, Robert Fogel, Florian S Gutzwiller, Steven Shen, Francesco Patalano, Donald Banerji, Konstantinos Kostikas and 1 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in American journal of respiratory and critical care medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.7field-weighted citation impact, top 26% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 8 citations in OpenAlex.

  1. Early Clinically Important Improvement (ECII) and Exacerbation Outcomes in COPD Patients.International journal of chronic obstructive pulmonary disease · 2020
    Trial
  2. Article
  3. Article
  4. Article
  5. Article
  6. Towards precision in defining COPD exacerbations.Breathe (Sheffield, England) · 2021
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 5 countries.

Stefan M Frent1 Department of Pulmonology, University of Medicine and Pharmacy Timisoara, Timisoara, Romania.ORCID 0000-0002-7469-6755
Kenneth R Chapman3 Department of Medicine, Asthma and Airway Centre, University Health Network, University of Toronto, Toronto, Ontario, Canada.
Michael Larbig4 Novartis Pharma AG, Basel, Switzerland.
Alexander Mackay2 European Respiratory Society Fellow at Novartis Pharma AG, Basel, Switzerland.
Robert Fogel6 Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; and.
Florian S Gutzwiller4 Novartis Pharma AG, Basel, Switzerland.
Steven Shen6 Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; and.
Francesco Patalano4 Novartis Pharma AG, Basel, Switzerland.
Donald Banerji6 Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; and.
Konstantinos Kostikas4 Novartis Pharma AG, Basel, Switzerland.
Jadwiga A Wedzicha5 National Heart and Lung Institute, Imperial College London, London, United Kingdom.
Novartis (Switzerland) · CHNovartis (United States) · USImperial College London · GBUniversity Health Network · CA

Funding

Department of Health RP-PG-0109-10056Medical Research Council G0800570Medical Research Council G1001365Medical Research Council G1001372
6 · The paper itself

Abstract

rationaleChronic obstructive pulmonary disease exacerbations accelerate lung function decline, reduce quality of life, and increase mortality. A subset of patients (n = 457) from the FLAME (Effect of Indacaterol Glycopyrronium vs. Fluticasone Salmeterol on COPD Exacerbations) study used the Exacerbations of COPD Tool (EXACT) to capture symptom-defined exacerbations.

objectivesTo evaluate the effect of indacaterol/glycopyrronium versus salmeterol/fluticasone on symptom-defined exacerbations measured using EXACT, and to assess differences between these events and exacerbations requiring healthcare resource use (HCRU).

methodsAll patients in FLAME used an electronic diary to record and detect symptom deteriorations; HCRU-related exacerbations were confirmed by investigators. In patients using the EXACT questionnaire, the onset, recovery, and magnitude of symptom-defined exacerbations were identified by changes in total scores relative to baseline. We analyzed the annualized rate and time to first symptom-defined (EXACT) exacerbation and assessed differences between symptom-defined and HCRU events in terms of number, severity, and concordance. MEASUREMENTS AND MAIN

resultsA nonsignificant 17% reduction in the annualized rate of symptom-defined (EXACT) exacerbations (rate ratio, 0.83; 95% confidence interval [CI], 0.60-1.14; P = 0.242) and a numerically longer time to first symptom-defined exacerbation were observed with indacaterol/glycopyrronium versus salmeterol/fluticasone (hazard ratio, 0.76; 95% CI, 0.56-1.03; P = 0.075). These results were consistent with data from the overall FLAME population. Of the symptom-defined (EXACT) events, 23.5% corresponded to HCRU events, and 22.2% of HRCU events were captured by EXACT (κ index, 0.24; 95% CI, 0.15-0.33).

conclusionsRegardless of the exacerbation definition used, our findings support the use of long-acting β

Indexed as

Bronchodilator AgentsDisease ProgressionDrug Therapy, CombinationFemaleFluticasoneGlycopyrrolateHumansIndansMaleMiddle AgedPulmonary Disease, Chronic ObstructiveQuinolonesRisk FactorsSalmeterol XinafoateSurveys and QuestionnairesBronchodilator AgentsFluticasoneGlycopyrrolateindacaterolIndansQuinolonesSalmeterol Xinafoateconcordancedefined symptomexacerbationtreatment

Identifiers

PMID30019939
PMCPMC6353015
OpenAlexW2884677787

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.