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 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT00889460
Eligibility Criteria:
Inclusion Criteria:
* written consent
* Male or female subject from 18 to 60 years old and in general good health
* For woman of child bearing potential:
* Symptoms of birch pollen induced allergic rhinitis for at least the last 2 years.
* Sensitisation to birch pollen as demonstrated with a positive SPT to birch pollen and specific IgE level (birch pollen and r Bet v1) \>0.70 kU/L at screening.
* FEV1 at least of 80% of predicted values at screening.
* Subject accepting to comply fully with the protocol.
Exclusion Criteria:
* Past or current disease which as judged by the Investigator, may affect the outcome of this study.
* History of life-threatening asthma,
* Asthma requiring daily treatment (whatever the pharmaceutical class).
* Pregnant or lactating woman.
* Subject being treated with inhaled steroids within 4 weeks prior to screening visit or within 12 weeks prior to screening visit.
* Subject who previously received desensitisation treatment to birch pollen and/or other betulaceae (e.g., hazel tree, alder) or who plan to start desensitisation treatment during this study.
* Symptoms during the treatment phase due to a sensitivity to a second allergen.
* Subjects treated with ongoing immunotherapy with another allergen
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00889460
Study Brief:
Protocol Section:
NCT00889460