Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy

Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy

The objective of this clinical trial is to assess the safety and efficacy of sublingual application of allergen extracts for specific immunotherapy in patients suffering from perennial allergic rhinitis due to house dust mites.

Inclusion Criteria:

• Positive history of perennial 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 with allergen extracts 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.