Efficacy of VALERGEN-DS sublingual vaccine in asthmatic adults

INTERVENTION: Active) study group: The study group was given increasing sublingual volumes (drops) of the researched vaccine at different doses (20, 200 and 2,000 BU/ml) for three weeks during the incremental phase. Afterwards, during the maintenance phase, a fixed dose was administered (20 drops of the 2,000 BU/ml dose, maximum permissible dose, 2,000 BU), until reaching twelve months, twice a week (Monday and Friday). Control group (placebo): The control group was given the placebo, namely, a diluent solution for allergenic extracts (BIOCEN). The placebo dosage was identical to that administered to the active group. allergenic extract, Dermatophagoides siboney Pyroglyphidae CONDITION: Asthma Bronchial asthma. PRIMARY OUTCOME: Score by symptoms, score by drug consumption, respiratory function (value of Exhalation Peak Flor (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 month and 1 year. SECONDARY OUTCOME: Respiratory function classification (depends on EPF and Variability), general evaluation (depends on symptoms, medication, respiratory function, Ch10). Measuring time: 6 month and 1 year. INCLUSION CRITERIA: 1. Asthmatic allergic patients with positive responses during the preliminary survey 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. siboney allergenic extract, 20,000 BU/ml VALERGEN‐DS. 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 giving their consent in writing to participate in our trial.