The purpose of this 2-year study is to assess the sustained clinical efficacy and safety of 300 IR/day of a sublingual solution of birch pollen allergen extract starting 4 months prior to the birch pollen season and continuing over the birch pollen season compared with placebo for reduction of rhinoconjunctivitis-related symptoms and anti-allergy medication usage.
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 previous 2 pollen seasons requiring intake of symptomatic treatment.
* Sensitization to birch pollen demonstrated by a positive Skin Prick Test to birch pollen with wheal diameter \> 3 mm and birch pollen allergens specific IgE levels ≥ 0.70 kU/L.
* RRTSS based on the previous or on the penultimate birch pollen season ≥ 12 out of a maximum possible score of 18.
* Patients with an FEV1 (Forced Expiratory Volume at one second) ≥ 80% of the predicted value.
* Patients who are willing to comply with the protocol.
* Patients having given a signed informed consent before completing any study related procedure.
Exclusion Criteria:
* Patients with symptoms of rhinitis/rhinoconjunctivitis during the birch pollen season due to any other allergens (except alder and hazel). This includes patients with symptomatic allergic rhinitis/rhinoconjunctivitis due to cat or dog allergens, and living with these animals at home or at risk of frequent contacts with these animals (family, friends etc.) during the course of the study.
* Patient who previously received desensitization treatment to birch pollen and/or another Betulaceae sp. (for example hazel or alder) within the previous 5 years.
* Patients with ongoing treatment by immunotherapy with another allergen.
* Pregnancy (positive pregnancy test), breast-feeding.
* Female patients of childbearing potential planning a pregnancy during this st…