A randomized double blind, placebo controlled study to evaluate the efficacy and security of immunotherapy with a depigmented and polymerized allergen extract of Dermatophagoides pteronyssinus in patients with asthma.

Conditions: Mild to moderate asthma caused by sensitization againts dust mite Dermatophagoides Pteronyssinus.
MedDRA version: 9.1Level: LLTClassification code 10001705Term: Allergic asthma

Registration Number: EUCTR2006-000602-23-PT

Lead Sponsor: aboratorios LETI S.L.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Voluntarily signed written informed consent
- Mild-to-moderate asthma (GINA-based classification: FEV1>60%)
- Patients between 14 and 45 years old.
- Clinical history of allergic asthma, due to clinical sensitization to house dust mite Dermatophagoides pteronyssinus.
- Positive skin tests to Dermatophgoides pteronyssinus: the wheal produced by means of the prick-test technique must be equal or superior to the wheal produced by the positive control of prick test (histamine 10 mg/ml).
- Presence of specific IgE to Dermatophagoides pteronyssinus (CAP > type 3).
- Patient able to fulfill the dosage regime.
- FEV1/FVC =70% of predicted value;

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patients who have received previously other immunotherapy treatment for the allergic asthma in the last four years.
- The patients in whom the immunotherapy can be object of absolute general contraindication will not be included, according to the criteria of the European Allergy and Clinical Immunology Immunotherapy Subcommittee (Malling HJ, Weeke B. Position Paper: Immunotherapy. Allergy 1993, suppl 14, 48: 9-35).
- Current treatment with ß-blocking agents
- Patients suffering from some pathology in which the adrenaline is contraindicated (hyperthyroidism, HTA, cardiopathy, etc.)
- Autoimmune disease (thyroiditis, lupus, etc.)
- States of the patient in which he can not offer co-operation, and with severe psychiatric disturbance.
- Pregnant women or with pregnancy risk and breast-feeding women.
- Intolerance to aspirin.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the efficacy and security of immunotherapy by means of a symptom+medication score in patients with mild to moderate asthma ;Secondary Objective: Comparison of sublingual and subcutaneous treatment <br>Evaluation of the treatment influence on the quality of life, dose-response prick test, inflammatory markers, serological levels of specific antibodies, intracellular expresion of IL-4, IL-10, TGB and Interferon gamma, respiratory function tests and pharmacological requirements.;Primary end point(s): Figure obtained at the symptom+medication score during the year of treatment

Secondary Outcome Measures