Extract allergen from Betula verrucosa. Test sensitivity and specificity of diagnostic in prick test preparation.

INMUNOTEK, S.L.0 个研究点目标入组 198 人开始时间: 2014年3月6日最近更新: 2018年12月4日

适应症

试验速览

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•- Positive clinical history or not of inhalation allergy (rhinitis I rhinoconjunctivitis I asthma) from Betula verrucosa
•-Allergic subjects, must submit a prick-test positive (average of the papule > 3 mm diameter) with a summary of the same allergen I presence against the allergen specific IGE.
•-The average diameter of the papule obtained by histamine dihydrochloride to 10 mgml must be >3mm
•- Age: from 5 to 70 years.
•- They must be capable of giving informed consent
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 100
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 48

•- Subjects outside of the age range.
•- Subjects who have previously received immunotherapy in the last 5 years for the treatment of asthma or the allergic rhinoconjunctivitis induced by allergens that may interfere with the allergen from Betula extract verrucosa
•- Subjects with important symptoms of rhinoconjunctivitis I bronchial asthma in which the suspension of the antihistamine treatment for systemic is contraindicated.
•- Subjects that have previously submitted a serious secondary reaction during skin prick test diagnostic tests.
•- Subjects treated with ss-blockers.
•- Unstable subjects of clinical point of view (asthma acute, febrile, etc).
•- Subjects with lesions of active hives, severe active dermographism, severe atopic dermatitis, sunburn, eczema, lesions of psoriasis in the area of realization of the prick test (risk of false positives).
•-Subjects with viral infection activates the herpes simplex or herpes varicella-zoster in the area of realization of the prick test.
•- Subjects that have some pathology in which the administration of adrenaline (hyperthyroidism, hypertension, heart disease, etc.) is contraindicated.
•- States of the subject that can not offer cooperation and severe psychiatric disorders.
•- Pregnant women at risk of pregnancy and breastfeeding women.

发起方

INMUNOTEK, S.L.