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:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT02809560
Eligibility Criteria:
Inclusion Criteria:
For Asthmatic children arm :
* Girl not in childbearing potential or taking contraceptive treatment
* Asthma diagnosis in at least 6 months as defined by clinical symptoms (expiratory dyspnea, wheezing, sibilance) and respiratory function (reversibility of VEMS at least 12% after salbutamol administration)
* Allergologic tests positives to airborne allergens : positive prick test and/or specific IgE \> 0,35 kU/L for at least one allergen
* Asthma severity between mild to moderate based on Global initiative for asthma classification during more than one month with inhaled corticotherapies +/- long term action beta -mimetic long compounds (salmeterol, formoterol)
* Patient insured with a social security scheme
For control children arm :
* Girl not in childbearing potential or taking contraceptive treatment
* No medical history of asthma
* No medical history of allergy or symptoms of allergy on skin (atopic dermatitis), respiratory tract (rhino-conjunctivitis, asthma) or food allergy
Exclusion Criteria:
For both arms:
* Chronic respiratory pathology : known occlusive or restrictive respiratory syndrome like interstitial lung disease, neuromuscular disease, mucoviscidoses, respiratory tract abnormalities with cough, dyspnea or digital hippocratism.
* History of pulmonary or nose and throat infectious disease during last 4 months
* Parasitic disease non treated during last 3 months
* Dyspnea during the inclusion
* Systemic corticotherapy during the last 3 months before inclusion
* Immunosuppressive therapy during the last 3 months before inclusion
* Diabeta
* Disease causing immune disorder
* Infection during inclusion
* Participation to another study witch implies medical treatment during last 3 months before inclusion
For asthmatic children arm :
* Chronic pulmonary pathology (excluding asthma)
* Asthma exacerbation during inclusion
* VEMS \< 70% of normal range or VEMS \< 70% of normal range after inhalation of serum (despite salbutamol administration)
* Patient unable to complete pulmonary function testing
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
18 Years
Study:
NCT02809560
Study Brief:
Protocol Section:
NCT02809560