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

Johann Wolfgang Goethe University Hospital34 enrolled

Overview

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.

see above

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Immunotherapy

Interventions

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

We treat each patient with mite-allergen following the two different protocols.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Goethe University, Department of Pulmonology

Frankfurt am Main, Hesse, Germany

Outcomes

Primary Outcomes

Safety of the shortened specific immunotherapy.

Time frame: may 2004 - march 2005

Secondary Outcomes

Exhaled nitric oxid (eNO) and immunogenicity (IgE, specific IgE, specific IgG) in both groups.

Time frame: may 2004 - march 2005

Data from ClinicalTrials.gov

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