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 @ 2:24 PM
Ignite Modification Date:
2025-12-24 @ 2:24 PM
NCT ID:
NCT01431859
Eligibility Criteria:
Inclusion Criteria:
* Male or female; age 18 with no upper age limit
* History of typical fruit-related symptoms on eating apples plus or minus other plant-derived foods known to be involved in the pollen-food syndrome
* History of spring rhinitis hay fever
* Positive skin prick test to birch pollen
* Positive open food challenge to apple
Exclusion Criteria:
* Significant medical conditions that may affect the risks of giving BP-SIT (especially uncontrolled asthma or ongoing need for beta-blockers)
* History of moderate to severe systemic reaction to apple, defined as any of: generalised urticaria, generalised angioedema, history convincing for laryngeal oedema, collapse
* Current immunological disease (auto-immune or thyroid disease, immunodeficiency)
* Malignant disease within the past five years (Patients with previous malignant disease that is considered cured, may be included subject to the consent of their oncologist)
* Inability to attend regularly for injections and follow-up visits
* Severe atopic dermatitis
* Previous immunotherapy with birch pollen extract
* Pregnant or not using adequate contraception (post-menopausal, surgically sterilised, long-term abstinent, or barrier methods plus spermicide)
* Breast-feeding
* Evidence of current drug or alcohol misuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01431859
Study Brief:
Protocol Section:
NCT01431859