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 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT04004351
Eligibility Criteria:
Inclusion Criteria for the cross-sectional analysis phase:
1. Child or adolescent aged from 5 to 17.
2. Patient suffering from House Dust Mites (HDMs)-associated allergic rhinitis, conjunctivitis and/or asthma.
3. Sensitization to HDMs as proven by a skin prick test or a serum specific IgE assay.
4. Patient eligible for HDMs sublingual immunotherapy.
5. Patient who never received HDMs sublingual allergen immunotherapy.
6. Patient in-print and orally informed on data recorded about him/her in connection with the study objectives.
7. Patient and parents (or guardians) agreeing to participate in the study.
Inclusion Criterion for the longitudinal analysis phase:
1\. HDMs sublingual immunotherapy prescribed at the end of the inclusion visit.
Exclusion Criteria:
1. Age under 5 or over 18.
2. Patient who already received HDMs sublingual allergen immunotherapy.
3. Patient showing contra-indications to immunotherapy: immune disorder, immunodeficiency, malignancy.
4. Participation in any clinical study involving an investigational product.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
17 Years
Study:
NCT04004351
Study Brief:
Protocol Section:
NCT04004351