Clinical Trials in France / NCT02114034
Active, not recruiting
Observational
Cohort Analysis of Clinical and Biological Severe Childhood Asthma
NCT02114034 · tracked via the Priya Life Science France tracker
Condition(s) studied
Severe Asthma
Study 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.
Eligibility
Inclusion Criteria:
Children with severe asthma:
* Child aged 3 to 12 years
* 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 or short acting nebulized bronchodilators (inhaler technique and compliance verified) presents one of the criteria following:
* Persistence of symptoms or chronic use of bronchodilators short duration of action at least three times a week for at least 3 months
* exacerbations in the previous year:
* at least one care unit admission or continued resuscitation
* at least two hospitalizations for acute severe asthma requiring IV therapy
* at least 2 courses of oral corticosteroids for exacerbations
* post BD FEV \<80% or UARS post BD\> 150% predicted
* Signature of consent or the holder (s) of parental authority
* Particular case of patients treated with Xolair® : Patients currently receiving Xolair® but who met the severity criteria of asthma, as described above, before the start of treatment with Xolair® are includable.
Children with non-severe asthma:
Inclusion Criteria
* Child aged 3 to 12 years
* Controlled without treatment or with low doses of inhaled corticosteroids (\<500 mg / day beclometasone equivalent) asthma
* Child with normal EFR (Child over 4 years)
* Child who did not have more severe exacerbation (assessed taking oral corticosteroids) in the previous year
* Child not admitted in the previous year for asthma.
* Signature of consent or the holder (s) of parental authority
Exclusion Criteria:
* Child with bronchopulmonary dysplasia
* Child with severe sequelae of viral infections
* Refusal of the child or parents Data collection for research and follow up of patients : tests carried out in the 3 months prior to inclusion are used
Blood sample for DNA extraction and the biobank: for young children, sampling at least 4 to 5 ml on dry tubes for serum and 6 ml at least for DNA. These samples should be stored at room temperature, transported within 48 hours to biological resources (CRB) Necker E,fa,ts Malades.
Primary outcome measure(s)
- The identification of risk factors for severe asthma — 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
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Service de Pneumologie et allergologie pédiatrique, Hôpital Necker-Enfants Malades | Paris | France |
More Assistance Publique - Hôpitaux de Paris trials in France
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02114034 on ClinicalTrials.gov ↗ ← All trials in France