Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy (Tablets) With Recombinant Bet v1
Phase 1
Completed
- Conditions
- Birch Pollen-Related RhinoconjunctivitisRhinitis, Allergic, Seasonal
- Interventions
- Biological: PlaceboBiological: rBet v 1
- Registration Number
- NCT00396149
- Lead Sponsor
- Stallergenes Greer
- 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 SLIT in subjects with allergic rhinitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo group Active group rBet v 1 rBet v 1 tablets
- Primary Outcome Measures
Name Time Method Local tolerability Assessed every day over 2 weeks Global safety Assessed every day over 2 weeks
- Secondary Outcome Measures
Name Time Method Immunological markers (IgE and IgG4) Between selection and follow-up visit
Trial Locations
- Locations (1)
National University Hospital - Allergy Unit 4222
🇩🇰Copenhagen, Denmark