Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-24 @ 4:11 PM
NCT ID:
NCT02806466
Eligibility Criteria:
Inclusion Criteria:
Asthmatic children
* Parents (and possibly the child) who gave written informed consent.
* Affiliated with a social security scheme.
* Age from 1 to less than 5 years.
* Severe persistent asthma according to the criteria of the National Health Authority (Annex I) or NEW PROPOSED CRITERIA (adapted ATS (42)):
Major criteria (\> 1) Asthma control in mild to moderate level requiring
1. A continuous or semi continuous (≥ 50% of the year) by oral corticosteroids
2. A treatment with high doses of inhaled corticosteroids (\> 500 micrograms / day of Beclomethasone, or equivalent (\> 400 micrograms / day of Budesonide,\> 200 micrograms / day of Fluticasone) for at least 6 weeks.
And
minor criteria (\> 2)
1. The need for an additional daily treatment (β2-agonists, long-acting, theophylline, anti-leukotrienes)
2. Symptoms that require taking daily or almost daily of β2-agonists of short action
3. persistent obstruction (FEV \<80% PEF variability\> 20%) (If reliable spirometry, usually\> 5 years of age)
4. One or more seeking care in emergency / year
5. At least three short courses of oral corticosteroids / year
6. Rapid Increases caused by the decrease of 25% of the dose of oral corticosteroids or inhaled
7. ATCD of severe acute asthma who put in life-threatening
Non-asthmatic children
* Non asthmatic child with indication of endoscopy:
* Any endoscopy for a disease without acute or chronic inflammation in the biopsy area (≥1 to \<5 years (1st part): congenital stridor, double aortic arch, foreign body removal inhaled, ...; ≥ 7 to ≤ 10 years ( 2nd component): inhaled foreign body removal, ...).
* Parents (and possibly the child) who gave written informed consent.
* Affiliated with a social security scheme.
* Children not asthmatic postmortem (retrospective and prospective)
* Age from 1 to under 5 (1st part) or aged 7 to 10 years (2nd part) on the death
* Died without pulmonary pathology in the sampled area
* Non asthmatic child with thoracic surgery:
* Age from 1 to under 5 (1st part) or aged 7 to 10 years (2nd part).
* Subject with pulmonary pathology, requiring thoracic surgery lobectomy, non-inflammatory in the sampled area.
* Parents (and possibly the child) who gave written informed consent.
* Affiliated with a social security scheme.
Exclusion Criteria:
Asthmatic children:
* Subject having a severe exacerbation of asthmatic disease requiring hospitalization in the 3 weeks preceding their inclusion.
* exclusion period on topic compared to another protocol.
* Subject with significant co-morbidity associated with asthma not of any nature whatsoever
* bronchial malformations (exclusion criterion ex post).
* Subject with a dental infection, or nasopharyngeal airway (viral or bacterial) with fever (\> 39 ° C) in the 4 weeks preceding the survey.
* chronic viral infections (hepatitis, HIV).
* non-specific inclusion criteria to endoscopy:
* Review of hemostasis abnormal,
* Subject with a heart condition,
* Subject is not fasted for over 6 hours.
Children without asthma:
* Non-asthmatic children with indication of endoscopy:
* asthma diagnosed by a doctor.
* exclusion period on topic compared to another protocol.
* Subject with significant co-morbidity associated with asthma not of any nature whatsoever.
* bronchial malformations (exclusion criterion ex post).
* Subject with a dental infection, or nasopharyngeal airway (viral or bacterial) with fever (\> 39 ° C) in the 4 weeks preceding the survey.
* chronic viral infections (hepatitis, HIV).
* non-specific inclusion criteria to endoscopy:
* Review of hemostasis abnormal,
* Subject with a heart condition,
* Subject is not fasted for over 6 hours.
* Children postmortem non-asthmatics:
* asthma diagnosed by a doctor.
* Subject with a dental infection, or nasopharyngeal airway (viral or bacterial) with fever (\> 39 ° C) within 4 weeks before sampling of tissue.
* chronic viral infections (hepatitis, HIV).
* Non-asthmatic children with thoracic surgery:
* asthma diagnosed by a doctor.
* exclusion period on topic compared to another protocol.
* Subject with a dental infection, or nasopharyngeal airway (viral or bacterial) with fever (\> 39 ° C) within 4 weeks before sampling of tissue.
* chronic viral infections (hepatitis, HIV).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
5 Years
Study:
NCT02806466
Study Brief:
Protocol Section:
NCT02806466