Asthma
Conditions
Interventions
Group A: VALERGEN-DP
Group B: VALERGEN-BT
In each group, there are 3 schemes. In each scheme, the treatment has an increasing and maintenance phase.
- Increasing phase: Sublingual Vaccination, dail
Sponsors
National Center of Bioproducts (BioCen)
Eligibility
Sex/Gender
All
Age
5 Years to 15 Years
Inclusion criteria
Inclusion criteria: 1. Asthmatic allergic patients with a clinical positive history of allergic symptoms provoked by the house-dust. 2. It proves cutaneous positive with the allergen extracts of D. pteronyssinus or B. Tropicalis to 20 000 UB / mL Keeping in mind that the cutaneous answer for the respective allergen is predominant when compared to that obtained with other mites, the patients will be included in one of the two groups: A: D. pteronyssinus, B: B. tropicalis) 3. Patients clinically diagnosed as extrinsic asthmatics that, 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 5 and 15 years. 5. Any sex and color skin. 6. Patient whose parents or tutors express their informed consent in writing to participate in the trial.
Exclusion criteria
Exclusion criteria: 1. Patients on allergenic extract immunotherapy during the two years before. 2. Patients classified as intermittent or severe persistent asthmatics after being interviewed. 3. Patients with a diagnostic of an autoimmune disease. 4. Generalized severe eczema. 5. Patients with diagnosed tumoral disease. 6. Patients on betablocker treatment. 7. Patients with psychiatric disorders. 8. Patients not cooperating with treatment. 9. Patients who needed,at least a year before the study, immunostimulant or immunosuppressor treatment (no corticosteroids) including interferon and cyclosporine A. 10. Pregnancy and breastfeeding (will be perform pregnancy test to females after menarche). 11. Adrenalin-contraindicated patients (high blood pressure). 12. Patients who, at least one year before the study, were under non-conventional treatments such as: Vimang, Aloe, ozone, banana capsules.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Symptom score: Dyspnea, cough, expectoration, wheeze and tightness (four-digit score: 0 = non symptom, 1 = mild, 2 = moderate, 3 = severe). Measuring time: daily during 6 months. Consumption of medications (three-digit score: 0= no use, 1= use beta-2 agonists, metilxantine, ephedrine, adrenaline, 2 = corticosteroids)). Measuring time: daily during 6 months. 2. Determination of Peak Expiratory Flow (PEF), (using standard meter of PEF: FERRARIS POCKETPEAK Measuring time: twice a day during 6 months. Skin reactivity: (value Ch10: relative allergen concentration causing in the patient a similar wheal to induced wheal by a HCL histamine solution (10 mg/mL= 54.3 mmol/L de Histamina base)). Measuring time: Pretreatment and 6 months. 3. Quality of life (PAQLQ(S)). Measuring time: Pretreatment and 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Allergen-specific antibodies (antibody titer determination and IgG4 serum allergen-specific IgE in patients using an indirect ELISA). Measuring time: 6 months. 2. Adverse events (AE). Measuring time: during 6 months. - Occurrence of some AE in the patient (yes/no). - Description of the AE (Name of adverse event). - According to available previous information (unexpected and expected) - According to its localization the expected AE (World Allergy Organization Criterion: local and systemic AE (0= Nonspecific Symptoms, I= Mild systemic reactions, II= Moderate systemic reactions, III= Severe (nonlife-threatening) systemic reactions, IV= Anaphylactic shock)). - Duration of the AE (Difference of dates between beginning and termination of event) - Intensity of the AE (Light, Moderate, Severe) - Seriousness of the AE (Serious, No serious) - Attitude regarding the treatment in study (without changes, dose modification, temporary or definitive interruption of the treatment in study) - Result of the AE (Recovered, Improved, Persists or sequels) - Relationship of causation of the AE (1.Very likely, 2.Likely, 3.Possible, 4.Unlikely, 5.Not related, 6.Not evaluated). Measuring time: Daily during the frits 23 days and monthly until 6 months. | — |
Countries
Cuba
Contacts
Public ContactRafaela Andina Corrales
Juan Manuel Marquez Pediatric Hospital
Outcome results
None listed