NCT02114034Active, not recruiting
Cohort Analysis of Clinical and Biological Severe Childhood Asthma
Source: ClinicalTrials.gov · Last updated 15 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 362 (actual)
- First submitted
- 22 Aug 2013
- Start date
- 12 Nov 2013
- Primary completion date
- Nov 2032
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Asthma
- NCT number
- NCT02114034
What you commit to
- Study type: Observational
- Participants enrolled: 362
- From 12 Nov 2013 to the primary completion date, Nov 2032
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Child with severe sequelae of viral infections
Lab values
- 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.
Other
- Child with bronchopulmonary dysplasia
Who the study is looking for
- 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:
- 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
Age in the registry: 3 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Service de Pneumologie et allergologie pédiatrique, Hôpital Necker-Enfants Malades Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.