Multicenter Trial of Immunotherapy With House Dust Mite Allergoid
Phase 3
Completed
- Conditions
- Rhinoconjunctivitis
- Interventions
- Biological: specific immunotherapy with Acaroid, subcutaneously, Up-titration till strength B 0.6 mL (6000 TU)
- Registration Number
- NCT00540631
- Lead Sponsor
- Allergopharma GmbH & Co. KG
- Brief Summary
Multicenter Immunotherapy House Dust Mite Allergoid
- Detailed Description
A multicentre randomized placebo-controlled double-blind clinical trial for evaluation of safety and efficacy of a specific immunotherapy with an aluminium hydroxide-adsorbed allergoid preparation of house dust mite (Dermatophagoides pteronyssinus) in patients with rhinitis/rhinoconjunctivitis and/or allergic asthma bronchiale
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
Inclusion Criteria
- Positive SPT
- Positive EAST
- Positive specific provocation test
Exclusion Criteria
- Serious chronic diseases
- other perennial allergies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A specific immunotherapy with Acaroid, subcutaneously, Up-titration till strength B 0.6 mL (6000 TU) Active treatment with house dust mite extract
- Primary Outcome Measures
Name Time Method The primary endpoint is the change of the area under the curve (AUC)of the Symptom-Medication-Score (SMS)after 2 years of double-blind treatment to baseline November 2007 - February 2010
- Secondary Outcome Measures
Name Time Method Immunologic changes IgE, IgG1 and IgG4 2 years Change of the AUC of the SMS after one year to baseline. 1 year Change of Nasal Eosinophil Cationic Protein (ECP) after 2 years to baseline 2 years Tolerability and safety of treatments during the entire study period 4 years
Trial Locations
- Locations (1)
Allergopharma GmbH & Co. KG
🇩🇪Reinbek, Germany