Dermatophagoides pteronyssinus and Dermatophagoides farinae allergen extract. Determination of the allergenic potency in vivo histamine equivalent units (HEP)

Inmunotek, S.L.0 个研究点目标入组 23 人开始时间: 2015年7月10日最近更新: 2022年8月8日

试验速览

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•-Clinical history positive inhalation allergy (rhinitis I rhinoconjunctivitis I asthma) against Dermatophagoides pteronyssinus or Dermatophagoides farinae.
•-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 area of the papule obtained by histamine dihydrochloride to 10 mgml must be greater than or equal 7 mm2.
•-Age: over 18 years of age.
•-Both sexes.
•Are the trial subjects under 18? no
•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 30
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-Subjects outside of the age range.
•-Individuals 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 extract mixture of Dermatophagoides pteronyssinus or farinae.
•-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 in treatment 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 or women at risk of pregnancy and breastfeeding women.

发起方

Inmunotek, S.L.