Status:
UNKNOWN
Can we Help People With the Oral Allergy Syndrome Eat Fresh Fruit?
Lead Sponsor:
Royal Sussex County Hospital
Conditions:
Oral Allergy Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Birch pollen allergy is increasingly common. It causes asthma and early season hay fever. This is because the body recognises birch pollen and reacts to it, leading to symptoms. Many patients with bir...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01431859
Start Date
July 1 2012
End Date
November 1 2016
Last Update
April 6 2016
Active Locations (1)
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1
Royal Sussex County Hospital
Brighton, East Sussex, United Kingdom, BN2 5BE