Combined sublingual immunotherapy VALERGEN-DP and VALERGEN-BT-Asthma-Adults-Phase II

Phase 2

Recruiting

• Conditions: Asthma; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Environmental Illness

• Registration Number: RPCEC00000240
• Lead Sponsor: ational Center of Bioproducts (BIOCEN)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

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 with similar diameter (difference not mayor of 2 mm) to allergenic extracts of D. pteronyssinus and B. tropicalis, VALERGEN, 20,000 BU/ml.
3. Patients included in the study will be patients clinically diagnosed as extrinsic asthmatics who, according the clinical-therapeutic identification booklet, are classified as mild or moderate persistent patients in keeping with the International Consensus on Asthma Diagnosis and Treatment (GINA).
4. Age between 18 and 45 years.
5. Any gender and skin color.
6. Patients expressing their consent in writing to participate in clinical trial.

Exclusion Criteria

1. Patients on allergenic extract immunotherapy during the two preceding years.
2. Patients classified as intermittent or severe persistent asthmatics after being interviewed.
3. Patients with a diagnosed autoimmune disease of any kind.
4. Generalized severe eczema.
5. Patients with diagnosed tumor disease.
6. Patients on beta-blocker treatment.
7. Patients with psychiatric disorders.
8. Patients not cooperating with treatment.
9. Patients who, at least one year before the study, needed immunestimulant or immunesuppressor treatment (no corticosteroids), including interferon and cyclosporine A.
10. Pregnancy and breastfeeding.
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