Compatibility and Immunogenicity of a Short Specific Immunotherapy (SIT) in Contrast to Classic Specific Immunotherapy

Study Overview
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Brief Summary
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We wanted to examine the immunogenicity and safety of a shortened specific immunotherapy in contrast to the standard specific immunotherapy. Therefore, we challenged 12 patients for 14 weeks with the standard specific scheme and 22 patients for 6 weeks with the shortened scheme.

Detailed Description
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see above

Official Title
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Compatibility and Immunogenicity of a Short Specific Immunotherapy (SIT) in Contrast to Classic Specific Immunotherapy in a Randomized Study Depending on Mite-Depot Supplement in Children and Adolescents With Allergic Bronchial Asthma.

Conditions
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Immunotherapy

Intervention / Treatment
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* Biological: specific subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: informed consent of patient and/or parents age >6 and <18 years bronchial asthma I° or II° allergy on house dust-mite Exclusion Criteria: age <6 and >18 years vital capacity <80% or FEV1 <70% pregnancy inhalative or systemic steroid use bronchial asthma III° or IV° heavy exacerbation during the last 3 months

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Standard specific immunotherapy: Novo-Helisen Depot, Allergopharma Inc., Reinbek, Germany | Biological: specific subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot)<br>* We treat each patient with mite-allergen following the two different protocols.<br>* Other names: Novo-Helisen Depot, Allergopharma Inc., Reinbek, Germany;|
| Active Comparator: 2<br>Shortened specific immunotherapy: Novo-Helisen Depot, Allergopharma Inc., Reinbek, Germany | Biological: specific subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot)<br>* We treat each patient with mite-allergen following the two different protocols.<br>* Other names: Novo-Helisen Depot, Allergopharma Inc., Reinbek, Germany;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the shortened specific immunotherapy. |  | may 2004 - march 2005 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exhaled nitric oxid (eNO) and immunogenicity (IgE, specific IgE, specific IgG) in both groups. |  | may 2004 - march 2005 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SIT, Immunotherapy, Mite, Asthma, bronchial provocation, specific immunotherapy