SUBLIVAC® Birch PROBE Study

Launched by HAL ALLERGY · Jul 2, 2009

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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

Trial Officials