Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-03 @ 12:38 AM
Study NCT ID:
NCT02114034
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-15
First Post:
2013-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cohort Analysis of Clinical and Biological Severe Childhood Asthma
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Cohort Analysis of Clinical and Biological Severe Childhood Asthma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COBRAPed
Brief Summary:
The purpose of this prospective study is:
* to identify by cluster analysis the main phenotypes of severe asthma and factors involved in the severity,
* to determine the clinical and functional outcomes,
* to identify the factors associated with severe asthma from childhood to adulthood.
* to identify by cluster analysis the main phenotypes of severe asthma and factors involved in the severity,
* to determine the clinical and functional outcomes,
* to identify the factors associated with severe asthma from childhood to adulthood.
Detailed Description:
Severe asthma involves about 5 % of asthmatic children and is associated with a high impact on hospitalizations, absenteeism and quality of life.
Although our knowledge has progressed in a substantial way during the last ten years, a number of unresolved questions persist in particular as regard to the contributing factors and outcomes from early childhood to adulthood.
After parental agreement the following elements will be collected at inclusion: clinical environmental data, pulmonary function, allergy test data (skin prick tests and specific IgE), blood and serum samples for biobank (DNA / SERUM). In a restricted number of children a more extensive work up will be performed which may include flexible bronchoscopy, bronchial brushing and bronchoalveolar lavage.
The follow-up will be performed every 6 months within the framework of the usual care including collection of clinical data and pulmonary function tests. The allergic status will be done again at 6-7 years, 12 years and 18 years.
In the group of children having non-severe asthma, the follow-up will be annual with collection of clinical data and pulmonary function tests.
Although our knowledge has progressed in a substantial way during the last ten years, a number of unresolved questions persist in particular as regard to the contributing factors and outcomes from early childhood to adulthood.
After parental agreement the following elements will be collected at inclusion: clinical environmental data, pulmonary function, allergy test data (skin prick tests and specific IgE), blood and serum samples for biobank (DNA / SERUM). In a restricted number of children a more extensive work up will be performed which may include flexible bronchoscopy, bronchial brushing and bronchoalveolar lavage.
The follow-up will be performed every 6 months within the framework of the usual care including collection of clinical data and pulmonary function tests. The allergic status will be done again at 6-7 years, 12 years and 18 years.
In the group of children having non-severe asthma, the follow-up will be annual with collection of clinical data and pulmonary function tests.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| N° ID RCB: 2012-A00539-34 | None | None | View |