PURETHAL Birch RUSH Study

Launched by HAL ALLERGY · Aug 7, 2013

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Signed informed consent.
• • Age ≥12 years.
• • Allergic rhinitis/rhinoconjunctivitis related to birch pollen with or without concomitant mild to moderate persistent asthma
• • FEV1\>70% for patients with a history of mild to moderate asthma, FEV1\>70% or PEF\>80% for patients without a history of asthma
• • A positive SPT (mean wheal diameter ≥ 3mm compared to negative control and negative control should be negative) for birch pollen.
• • Positive serum specific anti-birch IgE-test (\>0.7 U/ml) within 1 year before randomization and/or a positive provocation test for birch pollen within 1 year before randomization.
• Exclusion Criteria:
• • Immunotherapy (SCIT or SLIT) with birch pollen allergens within the past 5 years
• • Any specific immunotherapy (SCIT or SLIT) during the study period
• • Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs
• • Active malignancies or any malignant disease within the past 5 years
• • Severe uncontrolled diseases that could increase the risk for patients participating in the study
• • Acute/active inflammation or infection of the target organs at the start of the study
• • Secondary changes of the target organ
• • Diseases with a contraindication for the use of adrenaline
• • Use of systemic steroids within 4 weeks before start of the study and during the study
• • Treatment with systemic and local β-blockers
• • Vaccination within one week before start of therapy or during the initiation phase
• • Anti-IgE therapy within the 6 months prior to inclusion and during the study
• • Participation in a clinical study with a new investigational drug within the last 3 months or for a biological within the last 6 months prior to or during the study
• • Pregnancy, lactation or inadequate contraceptive measures for women of child-bearing age
• • Alcohol, drug or medication abuse within the past year
• • Any clinically significant abnormal laboratory parameter at screening
• • Lack or expected lack of cooperation or compliance
• • Severe psychiatric, psychological, or neurological disorders
• • Patients who are employees of the sponsor, institution or 1st grade relatives or partners of the investigator