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Preschool Bronchial Remodeling and Risk of Exacerbation

Bronchial REmodeling in Severe Preschool Wheezing chIldren and Risk of Exacerbation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04558671
Acronym
RESPIRE
Enrollment
56
Registered
2020-09-22
Start date
2020-09-16
Completion date
2020-09-24
Last updated
2020-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preschool Severe Asthma

Keywords

exacerbation, children, asthma, bronchial remodeling, wheezing

Brief 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.

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that subgroups of severe asthmatic children could also be identified according to bronchial remodeling parameters (unpublished data).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.

Interventions

OTHERasthma exacerbations

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

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
No

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

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

Design outcomes

Primary

MeasureTime frameDescription
Number of asthma exacerbations1 yearNumber of asthma exacerbations requiring systemic corticosteroid therapy within the year following the bronchoscopy performed in the P'tit Asthme study.

Secondary

MeasureTime frameDescription
Presence of the exacerbation prone asthma1 yearPresence of the exacerbation prone asthma defined by the occurrence of 3 or more asthma exacerbations requiring systemic corticosteroid therapy within one year
Number of asthma exacerbations requiring systemic corticosteroid therapy1 yearNumber of asthma exacerbations requiring systemic corticosteroid therapy each month within the year following the bronchoscopy performed in the P'tit Asthme study.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026