Status:
COMPLETED
Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy (Tablets) With Recombinant Bet v1
Lead Sponsor:
Stallergenes Greer
Collaborating Sponsors:
Quintiles, Inc.
Conditions:
Birch Pollen-Related Rhinoconjunctivitis
Rhinitis, Allergic, Seasonal
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
To investigate the safety and tolerability of successive single rising doses of SLIT in subjects with allergic rhinitis and to investigate the safety and tolerability of multi high dose regimens of SL...
Eligibility Criteria
Inclusion
- written consent
- Symptoms of birch pollen induced allergic rhinitis for at least the last 2 years.
- Sensitisation to birch pollen as demonstrated with a positive SPT to birch pollen and specific IgE level (birch pollen and r Bet v1) of at least Class 2 at screening.
- FEV1 at least of 80% of predicted values at screening.
Exclusion
- Patient who previously received desensitization treatment to birch pollen and/or other betulaceae (e.g., hazel tree, alder…) or who plan to start desensitization treatment during this study.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00396149
Start Date
November 1 2006
End Date
June 1 2007
Last Update
June 27 2013
Active Locations (1)
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1
National University Hospital - Allergy Unit 4222
Copenhagen, Denmark