Preschool Bronchial Remodeling and Risk of Exacerbation

Preschool Severe Asthma Clinical Trial

— RESPIRE  

Official title:

Bronchial REmodeling in Severe Preschool Wheezing chIldren and Risk of Exacerbation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04558671
• Other study ID #: CHUBX 2020/32
• Status: Completed
• Start date: September 16, 2020
• Est. completion date: September 24, 2020

Study information

• Verified date: September 2020
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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that subgroups of severe asthmatic children could also be identified according to bronchial remodeling parameters (unpublished data).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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 24, 2020
• Est. primary completion date: September 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Preschool Severe Asthma

Intervention

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

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux	Aquitaine
France	CHU de Toulouse	Toulouse	Languedoc-Roussillon-Midi-Pyrénées

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	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	1 year
Secondary	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.	1 year