Cohort Analysis of Clinical and Biological Severe Childhood Asthma (COBRAPed)
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|ClinicalTrials.gov Identifier: NCT02114034|
Recruitment Status : Active, not recruiting
First Posted : April 15, 2014
Last Update Posted : December 21, 2017
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.
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||362 participants|
|Official Title:||Cohort Analysis of Clinical and Biological Severe Childhood Asthma|
|Actual Study Start Date :||November 12, 2013|
|Estimated Primary Completion Date :||November 2032|
|Estimated Study Completion Date :||November 2032|
Asthmatic child who, despite treatment with a combination of inhaled corticosteroids (at least 800 mcg / day equivalent Beclomethasone) bronchodilators and long-acting or properly taken daily leukotriene (inhaler technique and compliance verified) presents one of the 3 criteria following:
- The identification of risk factors for severe asthma [ Time Frame: 18 years ]A prospective follow-up of a cohort of severe pediatric asthma. To improve the identification of risk factors for severe asthma, a group of children with non-severe asthma will also be included
- In the medium and longer term assessment [ Time Frame: 4 years ]
- Identify the functional and clinical outcome in a longitudinal follow-up to a link with asthma in adults.
- Identify the factors involved appearing during growth or adulthood (pediatric factors associated with severe asthma profile adult).
- A short-term assessment [ Time Frame: 4 years ]
- Identify the main phenotypes of severe asthma by the cluster analysis
- Identify the factors involved in severity during childhood
- Establish a collection of biological samples (serum bank, DNA Bank, tissue Bank) to search for biomarkers of severity and genetic risk factors for the development of asthma in children. [ Time Frame: 18 years ]
Biospecimen Retention: Samples With DNA
- whole blood
- Bronchoalveolar lavage fluid
- bronchial brushing and washing specimens
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02114034
|Service de Pneumologie et allergologie pédiatrique, Hôpital Necker-Enfants Malades|
|Paris, France, 75015|