Evidence map›Paper›PMID 31924197›Full record

Trial reportRespiratory research2020

Reduced risk of clinically important deteriorations by ICS in COPD is eosinophil dependent: a pooled post-hoc analysis.

Mona Bafadhel, Dave Singh, Christine Jenkins, Stefan Peterson, Thomas Bengtsson, Peter Wessman, Malin Fagerås

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Respiratory research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 10% 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

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Article
  6. Review
  7. Observational
  8. Towards precision in defining COPD exacerbations.Breathe (Sheffield, England) · 2021
    Review
  9. Observational
  10. Article
  11. Review
  12. Dual Bronchodilator in the Era of Triple Therapy.International journal of chronic obstructive pulmonary disease · 2020
    Review
  13. 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

7 authors at 5 institutions in 3 countries.

Mona BafadhelRespiratory Medicine Unit, Nuffield Department of Medicine, University of Oxford, Old Road Campus, Oxford, OX3 7LF, UK. mona.bafadhel@ndm.ox.ac.uk.ORCID http://orcid.org/0000-0002-9993-2478
Dave SinghMedicines Evaluation Unit, Manchester University NHS Foundation Trust, University of Manchester, Manchester, UK.
Christine JenkinsThe George Institute for Global Health, University of New South Wales, Sydney, Australia.
Stefan PetersonStatMind, Lund, Sweden.
Thomas BengtssonStatMind, Lund, Sweden.
Peter WessmanAstraZeneca, Gothenburg, Sweden.
Malin FageråsAstraZeneca, Gothenburg, Sweden.
AstraZeneca (Sweden) · SEWeMind · SEManchester University NHS Foundation Trust · GBUniversity of Oxford · GBUNSW Sydney · AU

Funding

AstraZeneca N/A
6 · The paper itself

Abstract

backgroundClinically Important Deterioration (CID) is a novel composite measure to assess treatment effect in chronic obstructive pulmonary disease (COPD). We examined the performance and utility of CID in assessing the effect of inhaled corticosteroids (ICS) in COPD.

methodsThis post-hoc analysis of four budesonide/formoterol (BUD/FORM) studies comprised 3576 symptomatic moderate-to-very-severe COPD patients with a history of exacerbation. Analysis of time to first CID event (exacerbation, deterioration in forced expiratory volume in 1 second [FEV

resultsThe proportion of patients with ≥1 CID in the four studies ranged between 63 and 77% and 69-84% with BUD/FORM and FORM, respectively, with an average 25% reduced risk of CID with BUD/FORM. All components contributed to the CID event rate. Experiencing a CID during the first 3 months was associated with poorer outcomes (lung function, quality of life, symptoms and reliever use) and increased risk of later CID events. The effect of BUD/FORM versus FORM in reducing CID risk was positively associated with the blood eosinophil count.

conclusionsOur findings suggest that BUD/FORM offers protective effects for CID events compared with FORM alone, with the magnitude of the effect dependent on patients' eosinophil levels. CID may be an important tool for evaluation of treatment effect in a complex, multifaceted, and progressive disease like COPD, and a valuable tool to allow for shorter and smaller future outcome predictive trials in early drug development.

Indexed as

Administration, InhalationAdrenal Cortex HormonesAdultAgedAged, 80 and overAnti-Asthmatic AgentsBronchodilator AgentsBudesonide, Formoterol Fumarate Drug CombinationDouble-Blind MethodEosinophilsFemaleHumansMaleMiddle AgedPulmonary Disease, Chronic ObstructiveRisk FactorsAdrenal Cortex HormonesAnti-Asthmatic AgentsBronchodilator AgentsBudesonide, Formoterol Fumarate Drug CombinationBudesonide/formoterolClinically important deterioration (CID)COPDEosinophilsExacerbations

Identifiers

PMID31924197
PMCPMC6954504
OpenAlexW2999276895

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.