Effect of Omalizumab (Xolair) on the threshold of degranulation and the composition of intracellular granules in skin mast cells and peripheral basophilic granulocytes before and during omalizumab therapy of patients with chronic urticaria (OTTO-Study) - OTTO-Study

Medical Faculty, Otto-von-Guericke-University Magdeburg0 个研究点开始时间: 2011年2月24日最近更新: 2013年12月9日

试验速览

暂无简介。

•- Persistent or intermittent symptoms of chronic urticaria and/or angioedema for at least 6 weeks despite treatment with antihistamines according to level 3 of the treatment algorithm of the international guidline for the management of urticaria [Zuberbier T. et al. (2009) EAACI/GA2LEN/EDF/WAO guideline: Management of urticaria. Allergy 2009: 64: 1427-1443]
•- Persistent symptoms of atopic dermatitis with or without allergic asthma despite treatment with antihistamines and/or topical application of steroids
•- The patient is able to understand the study, capable to give informed consent and available for 16 weeks of the trial
•- Age > 18
•- Written informed consent
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- Hypersensitivity against Omalizumab or one of the other contents of Xolair
•- Acute exacerbation of asthma, acute bronchospasms, asthmatic status
•- pregnancy or breast feeding
•- Age below 18
•- Systemic steroids or other immunosuppressants 4 weeks before Xolair-treatment
•- Severe disease e.g. cancer, AIDS, Hepatitis B/C, severe autoimmune diseases, severe liver- and/or kidney-dysfunction, insulin dependent diabtes mellitus or parasite (worm) infections
•- Treatment/pretreatment with Xolair
•- non-compliance and/or unability to understand necessary information for the trial

发起方

Medical Faculty, Otto-von-Guericke-University Magdeburg