The purpose of this study is to determine the efficacy and safety of three doses of r Bet v1 administered as sublingual tablets in birch pollen allergic subjects.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Symptomatic birch pollen-related allergic rhinoconjunctivitis for at least the last 2 pollen seasons
* Sensitisation to birch pollen as demonstrated, at screening, by a positive SPT to birch pollen with wheal diameter greater than 3 mm and specific IgE levels \> 0.70 kU/L (birch pollen and rBet v 1)
* Patients asymptomatic to all other allergens during the birch pollen season
* RRTSS during the previous pollen season ≥ 12 out of a maximum possible score of 18
* Patients with an FEV1 ≥ 80% of the predicted value
* Female patients with no childbearing potential
* Female patients of childbearing potential are eligible if they are not sexually active or if they use a medically accepted contraceptive method and have a negative urine pregnancy test, and are willing and able to sign written informed consent stating that they will use appropriate contraception and not plan a pregnancy during this study
* Patients able to be compliant with respect to the completion of the daily record card and taking of the investigational products
* Patients having provided signed informed consent
Exclusion Criteria:
* Patients with symptoms of rhinoconjunctivitis during the birch pollen season due to non-birch-related allergens
* Patients with symptomatic allergic rhinitis/rhinoconjunctivitis due to house dust mites
* Patients with symptomatic allergic rhinitis/rhinoconjunctivitis due to cat or dog allergens, and living with these animals at home or at risk of frequent conta…