NCT01013116
Unknown
Phase 3
A Double-blind Placebo-controlled Trial to Evaluate Efficacy and Safety of Specific Subcutaneous Immunotherapy in Patients With Perennial Allergic Rhinitis Due to House Dust Mites
Roxall Medizin0 sites120 target enrollmentApril 2016
ConditionsAllergic Rhinitis
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Allergic Rhinitis
- Sponsor
- Roxall Medizin
- Enrollment
- 120
- Primary Endpoint
- Symptom and medication score
- Last Updated
- 10 years ago
Overview
Brief Summary
The objective of this study is to evaluate the efficacy and safety of specific subcutaneous immunotherapy with modified allergen extracts.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Symptom and medication score
Time Frame: 1 year
Secondary Outcomes
- Safety of the treatment(1 year)
- Clinical global improvement(1 year)
- Quality of Life Questionnaire(1 year)
- Documentation of adverse events(1 year)
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