Status:
COMPLETED
Efficacy and Safety Trial of SLITone(TM) Birch in Subjects With Hayfever
Lead Sponsor:
ALK-Abelló A/S
Conditions:
Allergy
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The trial is performed to assess the efficacy and safety of SLIT One birch for treatment of birch pollen induced allergy
Detailed Description
Daily rhinoconjunctivits symptom and medication scores from patient diaries, adverse events
Eligibility Criteria
Inclusion
- A history of birch pollen allergy
- Positive skin prick test to birch
- Positive conjunctival test to birch
- Positive specific Immunoglobulin E (IgE) to birch
Exclusion
- Forced expiratory volume in 1 second (FEV1)\<70% of predicted value
- History of seasonal allergy interfering with study
- History of symptomatic perennial allergy
- History of emergency visit or admission for asthma in the previous 12 month
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT00310466
Start Date
June 1 2005
End Date
January 1 2007
Last Update
May 14 2013
Active Locations (1)
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1
Charité Klinik für Dermatologie, Venerologie und Allergologie
Berlin, State of Berlin, Germany, D-10117