Preventive sublingual immunotherapy for house dust mite sensitized preschool children - The PrevSens II Trial

Medical University of Vienna, Dpt. of Pediatrics0 个研究点开始时间: 2016年12月21日最近更新: 2017年1月23日

试验速览

暂无简介。

•Children four years of age with sensitization to house dust mite without clinical history of allergic symptoms are eligible for study participation:
•age of 4 years
•house dust mite sensitization (SPT > 3mm or specific IgE > 0.35 kU/l)
•additional sensitization to no maximum 3 inhalant or nutritive allergens in total (6-grass-pollen mix, birch pollen, cladosporium herbarum, alternaria alternata, peanut, cat- and dog dander, hen‘s egg and cow´s milk)
•no allergic symptoms from the upper airways and/or eyes during house dust mite exposure (validated by allergen provocation chamber exposure)
•other accepted atopic manifestations of the index child are:
•oIgE to food allergens without present food allergy, exposed to the particular food during the last 12 months,
•omild eczema with effective treatment of group 1-2 steroids,
•ovirus-induced asthma/preschool wheeze up to the last 12 months,
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 96
•F.1.2 Adults (18-64 years) no
•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

•Perennial upper airway symptoms (rhinorrhea, congestion),
•poly-sensitization to airborne and nutritive allergens, = 4 different inhalant allergens (6-grass-pollen mix, birch pollen, cladosporium herbarum, alternaria alternata, peanut, cat- and dog dander, hen‘s egg and cow´s milk),
•clinical food allergy with IgE-sensitization,
•at randomisation:
•osevere allergic rhino-conjunctivitis during pre-treatment season, need of systemic steroid,
•obronchial asthma, with regular use of inhaled corticosteroids, long-activating bronchiodilators (LABA) and/or anti-leukotriene receptor agonists,
•obefore or during treatment period - eczema, regular use of group 2 steroids >2 months the last 12 months,
•osevere allergic disease and or severe other disease,
•oother immune disease or children on immune regulating medication.
•pregnancy or lactation
•significant medical conditions, e.g. concomitant liver-, gastrointestinal-, kidney-, cardiovascular-, or pulmonary conditions, auto-immune diseases, hematological disorders or malignant diseases
•a history of monoclonal antibody therapy

发起方

Medical University of Vienna, Dpt. of Pediatrics