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

Conditions: Disease to be investigated: 12 patients with severe chronic urticaria (CU) with or without angioedema which continously need medical treatmentAs a control: 6 patients with atopy syndrome consisting of atopic dermatitis (AD) and/or allergic rhinoconjunctivits and allergic asthma which continously need medical treatmentAs an additional control: 6 healthy volunteers (1 blood sample, 1 skin sample, no Xolair treatment)
MedDRA version: 12.1Level: LLTClassification code 10009159Term: Chronic urticaria
MedDRA version: 12.1Level: LLTClassification code 10021247Term: Idiopathic urticaria
MedDRA version: 12.1Level: LLTClassification code 10003639Term: Atopic dermatitis
MedDRA version: 12.1Level: LLTClassification code 10031673Term: Other atopic dermatitis and related conditions

Registration Number: EUCTR2010-022864-12-DE

Lead Sponsor: Medical Faculty, Otto-von-Guericke-University Magdeburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- 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

Exclusion Criteria

- 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