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CompletedNCT04558671RESPIREUpdated Sep 29, 2020

Preschool Bronchial Remodeling and Risk of Exacerbation

An observational study in Preschool Severe Asthma, sponsored by University Hospital, Bordeaux. Completed at 2 sites in France. Open to participants aged 1 Year to 5 Years. Per ClinicalTrials.gov, last updated 2020-09-29.

Sponsored by University Hospital, Bordeaux · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
56
Ages
1 Year to 5 Years
Sex
All
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Study summary

Bronchial remodeling is an abnormal tissue repair process of the bronchial wall components that characterizes severe asthma which can include epithelial abrasion, thickening of the reticular basement membrane (RBM), an increase in bronchial fibrosis, blood vessel count, mucosal gland mass and/or bronchial smooth muscle (BSM) mass. We identified using latent class analysis two classes of patients. Compared to the second class, the first class was characterized by an increase in RBM thickness, blood vessel count, BSM mass and a decrease in RBM-BSM distance, mucus gland mass and bronchial fibrosis. We then hypothesized that this first latent class identified children at risk of asthma exacerbations.

Read the detailed description

Asthma is the most frequent chronic disease in children. Severe asthma is characterized by airway hyperresponsiveness, bronchial inflammation and bronchial remodeling 1. Bronchial remodeling is an abnormal tissue repair process of the bronchial wall components which can include epithelial abrasion, thickening of the reticular basement membrane (RBM), an increase in bronchial fibrosis, blood vessel count, mucosal gland mass and/or bronchial smooth muscle (BSM) mass. At preschool age (before 6 years old), asthmatic children constitute a heterogeneous population and several classifications have been proposed to identify distinct phenotypes according to the chronology of asthma 2, the triggers of asthma 3, the trajectory of lung function as measured by forced expiratory volume in 1 second (FEV1) 4 or according to a combination of clinical and inflammatory variables 5. More recently, we demonstrated for the first time using latent class analysis (LCA) that subgroups of severe asthmatic children could also be identified according to bronchial remodeling parameters (unpublished data). Indeed, we identified two latent classes of patients. Compared to the second class, the first latent class was characterized by an increase in RBM thickness, blood vessel count, BSM mass and a decrease in RBM-BSM distance, seromucosal gland mass and bronchial fibrosis (unpublished data). Since, previous studies showed that bronchial remodeling could have negative impact on the patients' outcomes, we therefore hypothesized that the latent classes identified from the bronchial remodeling data in severe preschool asthmatic children included in the "P'tit Asthme" study (NCT02806466) could identify children at risk of asthma exacerbations requiring systemic corticosteroids therapy.

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Conditions studied

  • Preschool Severe Asthma

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Keywords

  • exacerbation
  • children
  • asthma
  • bronchial remodeling
  • wheezing
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In context

Asthma

3,920 studies on the registry are indexed under Asthma; 506 are open to participants now.

This study's enrollment of 56 is below the median of 150 across 970 observational studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Severe preschool wheezers (1-5 years old) according to ERS and ATS modified criteria and requiring flexible bronchoscopy according to ERS guidelines.

Inclusion criteria

  • To have been previously included in the "P'tit Asthme" study (NCT02806466)
  • To have performed bronchoscopy with analyzable biopsies
  • To have been asthmatic at the inclusion in the P'tit Asthme study (NCT02806466)

Exclusion criteria

Exclusion Criteria:

  • To refuse the use of children data as expressed by representatives of parental authority
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
56 participants (actual)
Patient registry
No

Interventions

  • Otherasthma exacerbations

    to collect the number of asthma exacerbations between the 2 latent classes of patients within the year following bronchoscopy

06

What researchers measure

Primary outcomes

  1. Number of asthma exacerbations

    Number of asthma exacerbations requiring systemic corticosteroid therapy within the year following the bronchoscopy performed in the "P'tit Asthme" study.

    Time frame: 1 year

Secondary outcomes

  1. Presence of the exacerbation prone asthma

    Presence of the exacerbation prone asthma defined by the occurrence of 3 or more asthma exacerbations requiring systemic corticosteroid therapy within one year

    Time frame: 1 year

  2. Number of asthma exacerbations requiring systemic corticosteroid therapy

    Number of asthma exacerbations requiring systemic corticosteroid therapy each month within the year following the bronchoscopy performed in the P'tit Asthme study.

    Time frame: 1 year

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Study locations

2 sites
  • CHU de Bordeaux
    Bordeaux, Aquitaine 33000, France
  • CHU de Toulouse
    Toulouse, Languedoc-Roussillon-Midi-Pyrénées 31026, France
08

References and documents

Publications

  • Fayon M, Beaufils F, Esteves P, Campagnac M, Maurat E, Michelet M, Siao-Him-Fa V, Lavrand F, Simon G, Begueret H, Berger P; P'tit Asthme Study Group. Bronchial Remodeling-based Latent Class Analysis Predicts Exacerbations in Severe Preschool Wheezers. Am J Respir Crit Care Med. 2023 Feb 15;207(4):416-426. doi: 10.1164/rccm.202205-0913OC. PubMed 36108144 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04558671
Lead sponsor
University Hospital, Bordeaux
Responsible party
Sponsor
First posted
Sep 22, 2020
Start date
Sep 16, 2020
Primary completion
Sep 24, 2020
Completion
Sep 24, 2020
Last update
Sep 29, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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