SUBLIVAC® Birch PROBE Study

Inclusion criteria

• Subjects with allergic rhinoconjunctivitis with or without mild asthma (FEV1 ≥ 70%) due to birch pollen for at least 2 years.
• Use of anti-allergy symptomatic medication in the last birch pollen season (in case of a season with low pollen counts, in one of the two previous years).
• No seasonal allergic complaints induced by birch, grasses or mugwort pollen for at least 4 weeks in the absence of rescue medication during at least the last 2 weeks before the baseline.
• A positive SPT (diameter ≥3 mm) for birch pollen and a positive specific serum anti birch IgE-test (>1 U/ml).
• A positive TNPT with a birch allergen extract containing a concentration of 10, 100 or 1000 AU/ml at the baseline visit.
• Age 18 years and older.
• Subjects shall give a written informed consent.

Exclusion criteria

• A positive SPT (diameter ≥ 3mm) for hazel or alder and the maintenance dose will not be reached before 8 October 2009.
• A positive SPT (diameter ≥ 3mm) for pets and symptoms related to concomitant sensitization to pets while having these animals at home.
• A positive SPT (diameter ≥ 3mm) for house dust mite or moulds and clinically relevant symptoms related to concomitant sensitization to house dust mite or moulds, based on the investigator's research (TNPT for example).
• Allergy to any of the excipients of SUBLIVAC Birch or Staloral Birch.
• Chronic asthma or emphysema, particularly with an FEV1 < 70 % of predicted value or use of inhalation corticosteroids outside grass and tree pollen season for more than two episodes and/or longer than fourteen days.
• Specific findings for nose and mouth at screening or rhinoscopy before TNPT.
• Serious immuno-pathological diseases or malignancies (including auto-immune diseases, tuberculosis, HIV).
• Inflammation or infection of the target organ (nose, eyes and lungs).
• Severe atopic dermatitis requiring systemic immuno-suppressive medication.
• Allergen specific immunotherapy treatment for a period longer than 3 months within the last 5 years.
• History of life threatening anaphylactic events, including anaphylactic food allergy, insect venom anaphylaxis, exercise or drug induced anaphylaxis.
• A positive pregnancy test, lactation or inadequate contraceptive measures. (adequate measures: oral contraceptives, IUD, condom use and having no sexual relationship with a man)
• Alcohol- or drug abuse.
• Lack of co-operation or severe psychological disorders.
• Completed or ongoing long-term treatment with tranquilizer or psycho active drugs.
• Low compliance or inability to understand instructions/study documents
• Completed or ongoing treatment with anti-IgE-antibody
• Patients being in any relationship or dependence with the sponsor or investigator