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 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT02911220
Eligibility Criteria:
Inclusion Criteria:
* index case:
* Major
* Lack of respiratory disease documented in the medical record other than asthma
* Severe Asthma by definition ATS / ERS 2014:
* Treatment with high doses of CI and beta2 agonists for long-acting (B2LDA) or anti leukotriene or theophylline during the previous year or oral corticosteroids (CO) more than 50% from the previous year to prevent loss of control asthma.
* Asthma "uncontrolled" (at least 1 criteria):
* ACT \<20 and / or ACQ\> 1.5 (Asthma Control Test)
* 2 courses or more CO in the previous year
* 1 hospitalization for asthma in the previous year
* FEV \<80% predicted despite bronchodilators.
* Examination or medical record to find at least one member of the genetically non-atopic asthma associated family
* Prick negative tests for common allergens, questionnaire seeking negative atopy (SFAR Love) Phadiatop or negative diagnosis of non-atopic asthma confirmed by the adjudication committee
* informed and written consent of the patient to participate in the study
* Affiliated to a social security scheme
Exclusion Criteria:
* Pregnant women
* Minors
\- Known associated respiratory pathologies (COPD, bronchial dilatation, diffuse infiltrating pneumopathy)
* Major Trust
* Subject having demonstrated the inability or refusal to sign an informed consent
Relatives' patients:
* Major
* Related to the 1st and 2nd level of the index case or another member with family
* Related with or without a asthma (atopic or non-atopic)
* Informed and written consent of the patient to participate in the study Affiliated to a social security scheme
Exclusion Criteria:
* Pregnant women
* Minors
* Major Trust
* Subject having demonstrated the inability or refusal to sign an informed consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02911220
Study Brief:
Protocol Section:
NCT02911220