Evidence map›Paper›PMID 33123561›Full record

ArticleERJ open research2020

Impact of season and geography on CompEx Asthma: a composite end-point for exacerbations.

Alexandra Jauhiainen, Lieke E J M Scheepers, Anne L Fuhlbrigge, Tim Harrison, James Zangrilli, Esther Garcia Gil, Per Gustafson, Malin Fagerås, Carla A Da Silva

Open access · goldAbstract read
In one paragraph

Article in ERJ open research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.1field-weighted citation impact, top 50% 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. CompEx Asthma: is it time for a change in clinical trials?The European respiratory journal · 2025
    Article
  6. Modeling severe uncontrolled asthma: Transitioning away from health states.Contemporary clinical trials communications · 2024
    Article
  7. 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

9 authors at 5 institutions in 4 countries.

Alexandra JauhiainenBioPharma Early Biometrics and Statistical Innovation, Data Science & AI, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Lieke E J M ScheepersBioPharma Early Biometrics and Statistical Innovation, Data Science & AI, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Anne L FuhlbriggePulmonary Sciences and Critical Care, Dept of Medicine, University of Colorado School of Medicine, Denver, CO, USA.
Tim HarrisonNottingham NIHR Biomedical Research Centre, Respiratory Medicine, University of Nottingham, Nottingham, UK.
James ZangrilliBioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, USA.
Esther Garcia GilBioPharmaceuticals Medical, AstraZeneca, Barcelona, Spain.
Per GustafsonBioPharmaceuticals Medical, AstraZeneca, Gothenburg, Sweden.
Malin FageråsBioPharmaceuticals Medical, AstraZeneca, Gothenburg, Sweden.
Carla A Da SilvaEarly Respiratory and Immunology Clinical Development, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
AstraZeneca (Sweden) · SEAstraZeneca (Spain) · ESAstraZeneca (United States) · USNottingham Biomedical Research Centre · GBUniversity of Colorado Denver · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCompEx Asthma, a novel composite end-point combining severe exacerbations (SevEx) with asthma-worsening events, was recently developed. Further characterisation of CompEx Asthma is needed to illustrate the applicability of this end-point. The objective was to evaluate CompEx Asthma as a rate end-point to determine how seasonal and geographical factors impact this novel outcome.

methodsSeven 24-56-week randomised controlled trials of budesonide/formoterol (BUD/FORM) and benralizumab were analysed. Annualised event rates (AERs) and treatment effects (hazard ratio (HR)) were analysed with Poisson and Andersen-Gill models, respectively. Seasonality was analysed by month and five geographical regions were evaluated.

resultsThe studies included 10 815 patients (63% female, mean age 42-49 years). CompEx Asthma AER mirrored seasonal variations in SevEx AER. CompEx Asthma AERs were higher

conclusionThis study confirmed the reliability of CompEx Asthma as a rate end-point and allowed detection of variations in seasonal SevEx rates, reduction of variation in rates across regions and potential greater sensitivity to treatment effects.

Identifiers

PMID33123561
PMCPMC7569167
OpenAlexW3092933872

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.