Status:
COMPLETED
Sublingual Immunotherapy of Birch Pollen Associated Apple Allergy
Lead Sponsor:
Medical University of Vienna
Collaborating Sponsors:
Austrian Science Fund (FWF)
Conditions:
Birch Pollen Related Apple Allergy
Birch Pollen Allergy
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
More than 70% of birch pollen allergic patients suffer from allergic reactions to certain foods, e.g. stone fruits, hazelnut and some vegetables. However, specific immunotherapy (SIT) with birch polle...
Eligibility Criteria
Inclusion
- otherwise healthy persons between 18 und 50 years of age;
- positive history of rhinoconjunctivitis to birch pollen
- oral allergy syndrome(OAS) to apple
- positive skin prick test (SPT) reaction to birch pollen and apple
- specific IgE for Bet v 1 and Mal d 1
Exclusion
- Exclusion criteria
- Persons who due to their physical or mental state are not able to provide informed consent.
- Persons with underlying illnesses such as severe cardiopulmonary, malignant and/or autoimmune diseases
- Persons suffering from Hyper-IgE syndrome
- Persons receiving SIT during the past 5 years
- persons suffering from severe allergic reactions to apple such as generalized urticaria, asthma and/or anaphylaxis
- persons suffering from severe bronchial asthma to birch pollen
- persons suffering from pathological alterations of the lips and oral mucosa
- persons who are prescribed a treatment with immune-suppressive drugs, anti-histamines, leukotriene-antagonists or psychotropic drugs with anti-histaminic effects
- persons using ß-blockers
- Pregnant woman
Key Trial Info
Start Date :
March 14 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01449786
Start Date
March 14 2012
End Date
December 20 2016
Last Update
April 13 2017
Active Locations (1)
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1
Medical University of Vienna
Vienna, Austria, 1090