An observational study in Food Hypersensitivity and Anaphylaxis, sponsored by Novartis Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2025-06-18.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Observational
This was a retrospective, multi-center observational study conducted across four allergy departments in Europe (Berlin, Leipzig, Barcelona, and Basel). The study included patients with immunoglobulin E (IgE)-mediated food allergy who were treated with omalizumab, either as monotherapy or in combination with oral immunotherapy (OIT) between 2002-2022.
376 studies on the registry are indexed under Food Hypersensitivity; 90 are open to participants now.
This study's enrollment of 62 is below the median of 151 across 120 observational studies indexed under Food Hypersensitivity.
Browse Food Hypersensitivity studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
This was a retrospective, noninterventional cohort study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
None identified.
Adult patients diagnosed with IgE-mediated food allergy who received omalizumab treatment between 2002 and 2022.
This study also gives Omalizumab. No intervention listed here names it: that was found by reading the record.
Number of Patients by Response to Treatment
Patients were classified as treatment responders if an oral food challenge was negative, or a decrease in severity of food allergy during an oral food challenge was determined and no anaphylactic reactions occurred during treatment. Non-responders were those who experienced repetitive food anaphylactic reactions during treatment. Partial treatment responders were patients who experienced less than 1 food anaphylactic reaction despite undergoing treatment.
Time frame: Months 3, 6, 12, and 24
Frequency of Accidental Reactions
Accidental reactions were those that occurred when a patient unknowingly ingested the food allergen.
Time frame: Up to approximately 7 years
Change From Baseline in Allergen Threshold Levels
Allergen threshold was measured by oral food challenge test. The change in threshold level means the increase in the food dose that the patient was able to tolerate during the food challenge test.
Time frame: From Baseline up to approximately 7 years
Change From Baseline in Severity of Anaphylactic Reactions
Change in severity of food allergy was either demonstrated by an oral food challenge or based on the clinical assessment by the investigator.
Time frame: From Baseline up to approximately 7 years
Health-related Quality of Life (HRQoL) Based on Patient Reported Data as Measured by the EuroQol-5 Dimensions (EQ-5D) Questionnaire
The EQ-5D is a generic multidimensional measurement tool for describing HRQoL (EuroQol, 1999). The five domains of mobility, self-care ability, daily activities, pain/discomfort and anxiety/depression are considered. For each of the dimensions, the most appropriate answer from three given possibilities is selected (1=no problem, 2=moderate problem, 3=large problem). In addition, the patient marks the current state of health on a scale from 0 (worst conceivable state of health) to 100 (best conceivable state of health). HRQoL was measured if data was available.
Time frame: Months 3, 6, 12, and 24
HRQoL Based on Patient Reported Data as Measured by the Food Allergy Quality of Life Questionnaire (FAQLQ)
FAQLQs are disease-specific questionnaires used to measure the impact of food allergy on HRQoL. The forms are completed by the patients themselves or by the parents of food-allergic children and teenagers. Questions are scored on a 7-point scale from 1 (no) to 7 (maximal) impairment on quality of life. HRQoL was measured if data was available.
Time frame: Months 3, 6, 12, and 24
Ran from Jun 2023 to primary completion in Sep 2023, 3 months.
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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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