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 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT04583202
Eligibility Criteria:
Inclusion Criteria:
* A clinical history of allergic rhinitis to birch pollen for at least 2 consecutive pollen seasons requiring the taking of a symptomatic drug with or without associated asthma
* Positive skin prick tests for birch pollen (\> 3 mm)
* IgE specific to birch \> 0.75 kUI / L.
* Positive unit rapid nasal provocation test for birch pollen
* Subjects having signed informed consent
* Subjects affiliated to a social security scheme
* Subjects able to understand and complete the procedures related to the study
* Women of childbearing potential should have a negative pregnancy test throughout the study period with effective contraception
Exclusion Criteria:
* Specific immunotherapy (SIT) for birch allergens for more than a month in the 3 years preceding the screening
* Current use of Specific immunotherapy for another allergen
* Medical history of anaphylaxis following exposure to birch pollen
* Medical history of anaphylaxis linked to another allergen in the last 6 weeks
* Nasal polyps, nasal septum deviation or diagnosis of non-allergic rhinitis
* Subjects allergic to indoor environmental allergens (cat allergens, mold, dust mites) with - Obvious exposure to these allergens.
* Uncontrolled allergic pathology (rhinitis, conjunctivitis)
* Forced expiratory volume in 1 second (FEV1) \<70% of predicted normal values
* Moderate to severe asthma (GINA 3 to 5)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04583202
Study Brief:
Protocol Section:
NCT04583202