Evaluation of Efficacy and Safety of Specific Immunotherapy With Modified Allergen Extracts of House Dust Mites
Phase 3
- Conditions
- Allergic Rhinitis
- Interventions
- Biological: modified allergen extract of house dust mitesBiological: placebo
- Registration Number
- NCT01013116
- Lead Sponsor
- Roxall Medizin
- Brief Summary
The objective of this study is to evaluate the efficacy and safety of specific subcutaneous immunotherapy with modified allergen extracts.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- Positive history of perennial allergic rhinitis due to house dust mites
- 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 mite 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description modified allergen extract of house dust mites modified allergen extract of house dust mites - Placebo placebo -
- Primary Outcome Measures
Name Time Method Symptom and medication score 1 year
- Secondary Outcome Measures
Name Time Method Safety of the treatment 1 year Clinical global improvement 1 year Quality of Life Questionnaire 1 year Documentation of adverse events 1 year