Allergy, Bee Venom, Immunotherapy, Omalizumab
Conditions
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.
Interventions
DRUGomalizumab
Sponsors
The University Clinic of Pulmonary and Allergic Diseases Golnik
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* systemic mastocytosis, * pregnancy, * use of beta-adrenergic blocking agents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of systemic reactions during ultra rush immunotherapy build up phase and maintenance phase followed by omalizumab co-treatment. | 2 months |
Secondary
| Measure | Time frame |
|---|---|
| Changes in basophil sensitivity during omalizumab co-treatment | 2 years |
Countries
Slovenia
Contacts
Primary ContactPeter Kopac, MD
Outcome results
None listed