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 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT02943720
Eligibility Criteria:
Inclusion Criteria:
* Adult subjects 18 to 65 yrs old, male or female
* moderate to severe allergic Rhinitis/Rhinoconjunctivitis to birch pollen during the two preceding birch pollen seasons
* positive Skin Prick Test (SPT) to birch pollen extract
* positive specific IgE CAP to Bet v1.
Exclusion Criteria:
* persistent non-controlled asthma (Forced Expiratory Volume, FEV1 \< 85% of predicted),
* previous specific immunotherapy (SIT) to tree pollens,
* previous SIT to any allergen within 5 years,
* previous history of severe anaphylactic reaction,
* perennial allergic Rhinitis/Rhinoconjunctivitis,
* other disorder possibly influencing the trial outcomes,
* pregnancy,
* any severely debilitating disease,
* primary or secondary immunodeficiency or treatment with immunosuppressor drugs within one month prior to randomization (oral steroids, other immunosuppressors).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02943720
Study Brief:
Protocol Section:
NCT02943720