randomized double blind placebo controlled study on the efficacy of autologous autovaccine in house dust mite allergy - FIAVS

Conditions: Allergic diseases such as rhinoconjunctivitis or bronchial asthma are a major public health burden. The huge associated costs demand an evidence based therapeutic aproach. The only available causative therapy is the specific immuno-therapy (SIT). Auto-vaccine is another biogen substance, which derives from human-GI-tract bacteria. Its subcutaneous administration results in a Th-1 driven shift towards immunotolerance.

Registration Number: EUCTR2005-005534-12-DE

Lead Sponsor: The Symbio Herborn Group GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 24

Inclusion Criteria

otherwise healthy adults with house dust mite allergy prooven by positive prick test and bronchial provocation (FEV1 decrease > 20%). Episodic bronchial asthma (GINA 0-I°). Informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

allergies towards ingredients of the autovaccine. Bronchial asthma > GINA I°, other chronic diseases. Pregnancy.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Proove of concept for the efficacy of autologous autovaccine in the therapy of house dust mite allergy in adults. Determination of exhalative NO (eNO) as a marker of bronchial inflammation. Under the influence of the verum, we expect versus placebo a significant blockade of the synthesis of eNO.;Secondary Objective: Bronchial hyperresponsiveness will be determined by metacholin testing, a routine procedure in clinical praxis. Autovaccine-reated subjects are expected to show a reduced bronchial response towards inhalationof house dust mite-solution.<br>Other markers to assess bronchial inflammation will be sputum eosinophilia, and for systemic inflammation and allergic sensitization the determination of CD63, lipoprotein binding protein, and IgE;Primary end point(s): a significant reduction of eNO in the autovaccine treated group.

Secondary Outcome Measures