Multicenter Trial of Immunotherapy With House Dust Mite Allergoid

Study Overview
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Brief Summary
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Multicenter Immunotherapy House Dust Mite Allergoid

Detailed Description
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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

Official Title
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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

Conditions
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Rhinoconjunctivitis

Intervention / Treatment
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* Biological: specific immunotherapy with Acaroid, subcutaneously, Up-titration till strength B 0.6 mL (6000 TU)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Positive SPT Positive EAST Positive specific provocation test Exclusion Criteria: Serious chronic diseases other perennial allergies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: P<br>subcutaneous treatment with placebo Placebo- physiological saline containing histamine-dihydrochloride 0.1mL, 0.2mL, 0.4mL, 0.6mL of strength A(1000TU/mL) followed by 0.1mL, 0.4mL, 0.6mL by strength B (10000TU/mL) in weekly intervals | |
| Experimental: A<br>Active treatment with house dust mite extract | Biological: specific immunotherapy with Acaroid, subcutaneously, Up-titration till strength B 0.6 mL (6000 TU)<br>* Injection Number Date Proposed Dose Individual Dose Strength A=1000 TU/ml B=10000TU/ml ml Dose per Injection to be det. A 0.1 100 TU 7 (+7) days later A 0.2 200 TU 7 (+7) days later A 0.4 400 TU 7 (+7) days later A 0.6 600 TU 7 (+7) days later B 0.1 1000 TU 7 (+7) days later B 0.2 2000 TU 7 (+7) days later B 0.4 4000 TU 7 (+7) days later B 0.6 6000 TU Maintenance (Init 2,4) 4-6 weekly B 0.6 6000 TU To be continued Injection Number Date Proposed Dose Individual Dose Strength A=1000 TU/ml B=10000TU/ml ml Dose per Injection to be det. A 0.1 100 TU 7 (+7) days later A 0.2 200 TU 7 (+7) days later A 0.4 400 TU 7 (+7) days later A 0.6 600 TU 7 (+7) days later B 0.1 1000 TU 7 (+7) days later B 0.2 2000 TU 7 (+7) days later B 0.4 4000 TU 7 (+7) days later B 0.6 6000 TU Maintenance (Init 2,4) 4-6 weekly B 0.6 6000 TU To be continued<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Immunologic changes IgE, IgG1 and IgG4 |  | 2 years | 
| Tolerability and safety of treatments during the entire study period |  | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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House Dust Mite Allergen, Aluminium hydroxide-adsorbed