Omalizumab Treatment in Venom Immunotherapy With Systemic Reactions
- Registration Number
- NCT02968394
- Lead Sponsor
- The University Clinic of Pulmonary and Allergic Diseases Golnik
- Brief Summary
The purpose of this study is to evaluate if omalizumab co-treatment may allow reintroduction of honey bee venom immunotherapy in patients with immunotherapy treatment failure due to systemic reactions.
- Detailed Description
Some honey bee venom allergic patients cannot be treated with venom immunotherapy due to systemic reactions during immunotherapy - immunotherapy failure due to systemic reactions. High basophil allergen sensitivity is a risk factor for venom immunotherapy failure due to systemic reactions. Omalizumab decreases basophil sensitivity. Venom immunotherapy failure patients will be co-treated with omalizumab during another attempt of immunotherapy introduction. Patients will be clinically and immunologically followed up after the introduction.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 11
- severe anaphylactic reaction after honey-bee sting (Mueller grade III or IV) confirmed sensitization to honey-bee venom,
- honey-bee venom immunotherapy treatment failure due to systemic reactions.
- systemic mastocytosis,
- pregnancy,
- use of beta-adrenergic blocking agents.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NEVIT omalizumab Co treatment with omalizumab during another attempt of immunotherapy introduction
- Primary Outcome Measures
Name Time Method Number of systemic reactions during ultra rush immunotherapy build up phase and maintenance phase followed by omalizumab co-treatment. 2 months
- Secondary Outcome Measures
Name Time Method Changes in basophil sensitivity during omalizumab co-treatment 2 years
Trial Locations
- Locations (1)
University Clinic of Pulmonary and Allergic Diseases Golnik
🇸🇮Golnik, Slovenia