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

Johann Wolfgang Goethe University Hospital

Status and phase: Completed; Phase 3

Conditions: Immunotherapy

Treatments: Biological: specific subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00540150

97/04/FFM

Details and patient eligibility

About

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.

Full description

see above

Enrollment: 34 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

1

Active Comparator group

Description:

Standard specific immunotherapy: Novo-Helisen Depot, Allergopharma Inc., Reinbek, Germany

Treatment:

Biological: specific subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot)

2

Active Comparator group

Description:

Shortened specific immunotherapy: Novo-Helisen Depot, Allergopharma Inc., Reinbek, Germany

Treatment:

Biological: specific subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot)