Efficacy of VALERGEN-DP sublingual vaccine in asthmatic adults.

Phase 2

Conditions: Bronchial asthma
Asthma
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

Registration Number: RPCEC00000034

Lead Sponsor: ational Biopreparations Center (BIOCEN)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Asthmatic allergic patients with positive responses during the preliminary survey (Model 1) in the following aspects: family and personal history of atopy, clinical symptoms only triggered when exposed to dust at home, mainly indoors, when getting up in the morning or going to bed at night. 2. Skin test positive to D. pteronyssinus allergenic extract, 20,000 BU/ml VALERGEN-DP. The response to the allergen under study is predominant when compared to that obtained with other mites. 3. Patients included in the study will be patients clinically diagnosed as extrinsic asthmatics who, according to the clinical-therapeutic identification booklet, are classified as mild or moderate persistent patients in keeping with the International Agreement on Asthma Diagnosis and Treatment. 4. Age between 16 and 45 years. 5. Any sex and race. 6. Patients expressing their consent in writing to participate in our trial.

Exclusion Criteria

1. Patients not giving their consent in writing to participate in our trial. 2. Patients on allergenic extract immunotherapy during the two preceding years. 3. Patients classified as intermittent or severe persistent asthmatics after being interviewed. 4. Patients with a diagnosed autoimmune disease of any kind. 5. Generalized severe eczema. 6. Patients with diagnosed tumoral disease. 7. Patients on betablocker treatment. 8. Patients with psychiatric disorders. 9. Patients not cooperating with treatment. 10. Patients who, at least one year before the study, needed immunostimulant or immunosuppressor treatment (no corticosteroids), including interferon and cyclosporine A. 11. Pregnancy and breastfeeding. 12. Adrenalin-contraindicated patients (high blood pressure). 13. Patients who, at least one year before the study, were under non-conventional treatments such as: Vimang, Aloe, ozone, banana capsules.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Score by symptoms, score by drug consumption, respiratory function (value of Exhalation Peak Flow (EPF) and EPF Variability), cutaneous reactivity (Ch10 value: relative allergen concentration causing in the patient a bump similar to the one caused by a 10 mg/ml HCL histamine solution (54.3 mmol/l base histamine). Measuring time: 6 months and 1 year.

Secondary Outcome Measures

Name	Time	Method
Respiratory function classification (depends on EPF and Variability), general evaluation (depends on symptoms, medication, respiratory function, Ch10). Measuring time: 6 months and 1 year.