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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT01720251
Eligibility Criteria:
Inclusion Criteria:
* moderate to severe allergic rhinoconjunctivitis to birch pollen:
1. Score of symptoms of the Rhinoconjunctivitis Symptom Score (RSS) ≥ 12 during the two preceding birch pollen seasons
2. Previous use of anti-allergy medications during the two preceding birch pollen seasons
3. Positive SPT to birch pollen extract
4. Positive specific IgE CAP test for Bet v 1
Exclusion Criteria:
* uncontrolled asthma, FEV1 \< 80% of predicted
* previous SIT (specific immunotherapy) to birch pollen or any other SIT within 5 years
* clinical symptoms due to allergens other than birch pollen during the whole trial period
* history of anaphylaxis
* positive skin prick test to AllerT
* any other treatment or conditions which may increase the risk of the study for the subject or affect the efficacy assessments during the birch pollen season
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01720251
Study Brief:
Protocol Section:
NCT01720251