Efficacy and Safety of Sublingual Immunotherapy (SLIT)

A Multicenter Randomized DBPC Trial to Evaluate Efficacy and Safety of Sublingual Immunotherapy (SLIT) With Allergen Extracts From Pollen in Patients With Seasonal Allergic Rhinitis

The purpose of this study is to evaluate the efficacy and safety of specific sublingual immunotherapy (SLIT) with allergen extracts in patients suffering from seasonal allergic rhinitis .

Inclusion Criteria:

• Positive history of allergen specific seasonal allergic rhinitis
• Positive screening skin prick test (wheal diameter > 3 mm)
• Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication
• Signed and dated patient´s Informed Consent,

Exclusion Criteria:

• Previous immunotherapy within the last 3 years,
• Simultaneous participation in other clinical trials,
• Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance),
• Auto-immune disorders,
• Severe chronic inflammatory diseases,
• Malignancy,
• Alcohol abuse,
• Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection,
• Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.