Safety and Tolerability Study of rBet v1 SLIT Tablets (NCT00889460) | Clinical Trial Compass
CompletedPhase 1
Safety and Tolerability Study of rBet v1 SLIT Tablets
Denmark55 participantsStarted 2007-11
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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