Food Allergy with Anaphylaxis MedDRA version: 20.0 Level: LLT Classification code 10014315 Term: Egg allergy System Organ Class: 100000004870 MedDRA version: 20.0 Level: LLT Classification code 10016709 Term: Fish allergy System Organ Class: 100000004870 MedDRA version: 20.0 Level: LLT Classification code 10040539 Term: Shellfish allergy System Organ Class: 100000004870 MedDRA version: 20.0 Level: LLT Classification code 10001745 Term: Allergy to cow's milk System Organ Class: 100000004870
Conditions
Interventions
Trade Name: Xolair
Pharmaceutical Form: Injection
INN or Proposed INN: OMALIZUMAB
CAS Number: 242138-07-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300 -
Sponsors
Odense Research Center for Anaphylaxis (ORCA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 10 male or female subjects, age 18 - 70 years with verified allergy to a food allergen, where validated methods for determination of specific IgE to the food and to the major allergens (Component Resolved Diagnostics) are available. The foods include, but will not be confined to milk, egg, peanut, hazelnut, sesame, wheat, cod and shrimp. Patients with/without elevated levels of total IgE (> 1000 kIU/l) will be included. Minimum level of specific IgE to the major allergen component in the food in question will be 10 kIU/l. No control group will be included. 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 9 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: •Ischemic heart disease or other significant co-morbidity (e.g. uncontrolled asthma) that might compromise the patient’s safety or study outcomes. •Infection on the day of study •Pregnancy or nursing •Ongoing treatment with antihistamine or drugs with antihistaminic properties that cannot be paused three days prior to the tests •Ongoing treatment with ß-blockers that cannot be paused one day prior to the tests •Ongoing treatment with oral glucocorticoids (>10 mg daily) •Alcohol abuse, abuse of opioids or other drugs •Occurrence of unexpected side effects •Patients who are not supposed to be able to meet the requirements in the protocol •Patients who are physically or mentally unable to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim will be to investigate if the combination of initial IgE-specific immunoadsorption and subsequent therapy with Omalizumab will increase the clinical threshold to the culprit food and thus prevent medical emergencies in patients with food anaphylaxis.;Secondary Objective: Not applicable;Primary end point(s): Primary parameters: Clinical thresholds before, during and after therapy (Tr0, TrP, TrX and TrW) will be determined for each patient as described. Serum levels of total and specific IgE together with skin prick test and basophil histamine release test will be determined at the time points described. Since clinical threshold values may fluctuate spontaneously over time, only a change exceeding 1 challenge step will be considered clinically significant. Since the theoretical maximal efficacy of the combined therapy is a forty fold increase in threshold (a factor of 10 by plasmapheresis and a factor of at least 4 by Omalizumab 300 mg) the expected change from Tr0 to TrX will be at least a factor of 10, corresponding to at least two dose steps. No difference between Tr0 (before therapy) and TrW (four weeks after cessation of therapy is expected, although an effect on lymphocytic B-cells after repeated immunoadsorption has been suggested. ;Timepoint(s) of evaluation of this end point: not applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The reduction in total IgE as well as the reduction of the levels of specific IgE to the major components of the allergen will be correlated to the corresponding thresholds. An inverse correlation is expected. Reduction in SPT size and a shift to the right of basophil histamine release is also expected.;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Denmark
Contacts
Public ContactCarsten Bindslev-Jensen
Odense Research Center of Anaphylaxis (ORCA)
Outcome results
None listed