Specific immunotherapy of birch pollen-related food allergy

Medical University of Vienna0 个研究点目标入组 60 人开始时间: 2011年12月15日最近更新: 2020年7月20日

适应症

试验速览

暂无简介。

•All patients must have suffered from birch pollen-induced allergic rhinitis
•and apple-induced birch pollen-associated oral food allergy for at least the last 2 years, positive skin prick tests (SPT) to birch pollen and specific IgE levels to birch pollen, rBet v 1 and rMal d 1 >0.70 kU/L at screening. Moreover, patients must have positive prick-to-prick (PtP) tests with apple and respond positive in double blind placebo controlled food challenges (DBPFCF) with GMP-rMal d 1
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 60
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Exclusion criteria will be: malignancies, autoimmune and
•cardiopulmonary diseases, anemia, hyper-IgE syndrome, intake of betablockers, a history of life-threatening asthma or daily requirement of asthma treatment. Patients who had previously developed severe
•symptoms to apples will as well as patients being treated with inhaled
•steroids within 4 weeks prior to screening visit cannot be included. None of the patients should currently undergo SIT to any allergen source or have undergone birch pollen SIT during the past 5 years. Pregnant and lactating women will also be excluded

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