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.

aboratorios LETI S.L.0 个研究点开始时间: 2007年5月25日最近更新: 2012年3月19日

适应症

试验速览

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•- 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

•- 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.

发起方

aboratorios LETI S.L.