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 @ 12:46 PM
Ignite Modification Date:
2025-12-24 @ 12:46 PM
NCT ID:
NCT06267261
Eligibility Criteria:
Main Inclusion Criteria:
* Subjects who signed the written informed consent,
* Subjects covered by health social identification number,
* Subjects able to understand and complete study-related procedures,
* Subjects reported history of symptomatic birch pollen allergen-triggered asthma (GINA1) with associated allergic rhinitis,
* Positive skin prick test (SPT) with cat hair extract with mean wheal diameter ≥ 5 mm compared to negative control (NaCl reaction \< 2 mm),
* Positive sIgE tests for birch tree pollen and Bet v 1 (≥0.7 kUa/L),
* Subjects with FEV1 ≥ 70% predicted at screening and before allergen exposure,
* Subjects with at least one drop in FEV1 ≥20% during the 1-hour baseline exposure
* ACT≥ 20,
* Women of childbearing potential with a negative pregnancy test throughout the study period and a highly effective contraception: oral contraceptives, condom with spermicide, intrauterine device, bilateral tubal ligation, vasectomized partner.
Main Exclusion Criteria:
* Allergen immunotherapy to birch pollen allergen for more than 1 month in the 3 years prior to the screening visit,
* Ongoing allergen immunotherapy to another allergen,
* History of anaphylactic reactions to birch allergen exposure or birch allergen immunotherapy,
* History of anaphylactic reactions to another allergen in the last 6 weeks before inclusion,
* Nasal polyposis, deviation of nasal septum or diagnosis of uncontrolled non-allergic rhinitis,
* Subjects allergic to indoor environmental allergens (molds, house dust mite allergens) with obvious exposure to these allergens causing allergic symptoms,
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06267261
Study Brief:
Protocol Section:
NCT06267261