- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04558671
Preschool Bronchial Remodeling and Risk of Exacerbation (RESPIRE)
September 28, 2020 updated by: University Hospital, Bordeaux
Bronchial REmodeling in Severe Preschool Wheezing chIldren and Risk of Exacerbation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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that subgroups of severe asthmatic children could also be identified according to bronchial remodeling parameters (unpublished data).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blood vessel count, BSM mass and a decrease in RBM-BSM distance, seromucosal gland mass and bronchial fibrosis (unpublished data).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.
Study Type
Observational
Enrollment (Actual)
56
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Aquitaine
-
Bordeaux, Aquitaine, France, 33000
- CHU de Bordeaux
-
-
Languedoc-Roussillon-Midi-Pyrénées
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Toulouse, Languedoc-Roussillon-Midi-Pyrénées, France, 31026
- CHU de Toulouse
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of asthma exacerbations
Time Frame: 1 year
|
Number of asthma exacerbations requiring systemic corticosteroid therapy within the year following the bronchoscopy performed in the "P'tit Asthme" study.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of the exacerbation prone asthma
Time Frame: 1 year
|
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
|
Number of asthma exacerbations requiring systemic corticosteroid therapy
Time Frame: 1 year
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 16, 2020
Primary Completion (Actual)
September 24, 2020
Study Completion (Actual)
September 24, 2020
Study Registration Dates
First Submitted
September 16, 2020
First Submitted That Met QC Criteria
September 16, 2020
First Posted (Actual)
September 22, 2020
Study Record Updates
Last Update Posted (Actual)
September 29, 2020
Last Update Submitted That Met QC Criteria
September 28, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2020/32
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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