Sublingual immunotherapy with VALERGEN-Asthma-Children-Phase II

Phase 2

Completed

• Conditions: Asthma

• Registration Number: RPCEC00000125
• Lead Sponsor: ational Center of Bioproducts (BioCen)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 300

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br><br>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. <br><br>3. Quality of life (PAQLQ(S)). Measuring time: Pretreatment and 6 months.