Status:
COMPLETED
Safety and Tolerability Study of Ragweed SLIT Tablets
Lead Sponsor:
Stallergenes Greer
Collaborating Sponsors:
Quintiles, Inc.
Conditions:
Rhinitis, Allergic, Seasonal
Ragweed Pollen Allergy
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 ragweed pollen allergen extract administered as sublingual tablets in subjects with allergic rhinitis to ragwe...
Eligibility Criteria
Inclusion
- written consent
- male or female subjects from 18 yo 60 years old and in general good health
- for women of child bearing potential: negative urine pregnancy test and use of medically effective contraceptive method
- symptoms of ragweed pollen induced allergic rhinitis for at least the last 2 years
- sensitization to ragweed pollen as demonstrated with positive skin prick test to ragweed pollen and specific IgE level (ragweed pollen) \> 0.70 kU/l at screening
- FEV1 at least of 80% of predicted value at screening
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 women
- subjects who previously received desensitisation treatment to ragweed pollen and/or other Asteraceae 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 :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01224834
Start Date
January 1 2009
End Date
October 1 2009
Last Update
November 8 2010
Active Locations (1)
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1
DRC Drug Research Center
Balatonfüred, Hungary, H-8230