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 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT02478060
Eligibility Criteria:
Inclusion Criteria:
* Male or female, aged 18 to 65 years;
* Minimum 1 year history of rhinitis with or without conjunctivitis on exposure to birch pollen
* Birch IgE ≥ 0.35 kU/L
* Positive skin prick test to whole birch allergen
Exclusion Criteria:
* Any past history of asthma
* FEV1 \< 80% of predicted
* History of severe allergic reaction to birch allergen, severe drug allergy, severe angioedema or severe allergic reactions to food
* Acute phase skin response to whole birch allergen with a mean wheal diameter \> 50mm
* Administration of adrenaline (epinephrine) is contraindicated
* History of severe drug allergy or anaphylactic reaction to food.
* History of any significant disease or disorder (e.g. immune system, pulmonary, cardiovascular, gastrointestinal, liver, renal, neurological, metabolic, malignant, psychiatric, major physical impairment, history of alcohol or drug abuse)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02478060
Study Brief:
Protocol Section:
NCT02478060