Disease to be investigated: 12 patients with severe chronic urticaria (CU) with or without angioedema which continously need medical treatment As a control: 6 patients with atopy syndrome consisting of atopic dermatitis (AD) and/or allergic rhinoconjunctivits and allergic asthma which continously need medical treatment As an additional control: 6 healthy volunteers (1 blood sample, 1 skin sample, no Xolair treatment) MedDRA version: 12.1 Level: LLT Classification code 10009159 Term: Chronic u
Conditions
Interventions
Trade Name: Xolair
Product Name: Xolair
Product Code: IGE025
Pharmaceutical Form: Concentrate and solvent for solution for injection
Sponsors
Medical Faculty, Otto-von-Guericke-University Magdeburg
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Severe chronic urticaria (CU) or atopic dermatitis (AD) are burdening diseases. Continuous medication is required, quality of life is low. In the proposed trial we plan to treat 12 CU- and 6 AD-patients with Xolair which is an established drug for treatment of severe asthma, but not approved for CU/AD. However, multiple case reports and case series demonstrated a benefit for these patients. Omalizumab, therefore, is part of the EAACI/GA2LEN/EDF/WAO guidline for management of CU [Allergy 2009:64:1427-1443]. Protocol: Treatment with 4 x 300 mg Xolair at week 0, 4, 8, 12 s.c. (in the Xolair-range approved for asthma). Blood sampeling at week 0, 4, 8, 12, 16, skin punch biopsies (6 mm) from uninvolved / involved skin at week 0, 16 and after the first clinical effect. Clinical scores, quality of life, amount of co-medication and safety measures at week 0, 4, 8, 12, 16. Main objective: significant improvement of clinical symptoms and/or quality of life and/or amount of co-medication.;Secondary Objective: In mast cells and basophilic granulocytes of patients with CU, for various stimuli the signal threshold which has to be reached to induce degranulation is lower as compared to healthy individuals, and hyperreleasability of granules is a well known phenomenon. To be clinically effective, Xolair has to normalize these alterations in the long run, i.e. has to directly or indirectly "calm down" the degranulation machinery. This hypothesis can be tested. Determination of degranulation thresholds before/during omalizumab-therapy will be the main scientific focus of the project: Analysis of intracellular composition of granules, changes before/during therapy and analysis of the signal transduction molecules governing degranulation, changes before/during therapy. ;Primary end point(s): There primary clinical end point is the clinical effect after 16 weeks of treatment. The primary study parameter is the dynamics of degranulation of mast cells /and or basophili | — |
Countries
Germany
Outcome results
None listed