Status:
COMPLETED
Safety and Tolerability Study of rBet v1 SLIT Tablets
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
The purpose of this study is to determine the safety and tolerability of several doses of r Bet v1 administered as sub-lingual tablets in subjects sensitised to birch pollen.
Eligibility Criteria
Inclusion
- written consent
- Male or female subject from 18 to 60 years old and in general good health
- For woman of child bearing potential:
- 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) \>0.70 kU/L at screening.
- FEV1 at least of 80% of predicted values at screening.
- Subject accepting to comply fully with the protocol.
Exclusion
- Past or current disease which as judged by the Investigator, may affect the outcome of this study.
- History of life-threatening asthma,
- Asthma requiring daily treatment (whatever the pharmaceutical class).
- Pregnant or lactating woman.
- Subject being treated with inhaled steroids within 4 weeks prior to screening visit or within 12 weeks prior to screening visit.
- Subject who previously received desensitisation treatment to birch pollen and/or other betulaceae (e.g., hazel tree, alder) or who plan to start desensitisation treatment during this study.
- Symptoms during the treatment phase due to a sensitivity to a second allergen.
- Subjects treated with ongoing immunotherapy with another allergen
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00889460
Start Date
November 1 2007
End Date
April 1 2008
Last Update
April 29 2009
Active Locations (1)
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1
National University Hospital - Allergy Unit 4222
Copenhagen, Denmark, 2100