The influence of omalizumab (Xolair ) on the composition of intracellular granules and Degranulationsschwelle of skin mast cells and peripheral basophils before and during omalizumab therapy in patients with chronic urticaria

Phase 4

• Conditions: L20.8; L50.8; Other urticaria; Other atopic dermatitis

• Registration Number: DRKS00003280
• Lead Sponsor: niversitätsklinikum MagdeburgDekan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-12
• Study Completion: 2013-02-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

intermittent or persistent symptoms of chronic urticaria and / or angioedema for at least 6 weeks to treat refractory stage 3 of the international guideline CU, or
- Persistent symptoms of AD with / without allergic / s asthma despite treatment with topical steroids drug class two and systemic therapy with antihistamines.
- The / the patient / in is able to understand the study, to give his / her consent and is available for the study duration.
- Written consent after thorough verbal and written explanation is given.

Exclusion Criteria

- Hypersensitivity to omalizumab or Xolair one of the ingredients.
- Xolair therapy in history
- Immunosuppressive medication 4 weeks before study entry
- Acute asthma exacerbations, acute bronchospasm, status asthmaticus
- Pregnancy
- Severe other diseases: for example HIV, chronic hepatitis B / C, severe autoimmune disease or with pre-existing renal or hepatic dysfunction.
- Non-compliance and / or inability to understand the context in the study required information.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of disease activity before and after therapy<br><br> Comparing the release rate of Granulasysteme from basophils and mast cells before and after therapy

Secondary Outcome Measures

Name	Time	Method
Reduction of drug consumption,<br> Therapy Safety (survey of possible side effects)<br>Influence of quality of life,<br> change of the composition of granula in situ<br> Paraclinical parameters change