NCT06316414

Omalizumab in Severe Asthmatics With Food Allergy

Effects of Omalizumab on Food Allergy in Children With Severe Asthma: A Real Life Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 65 (actual)
• Sponsor: Bambino Gesù Hospital and Research Institute · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective assessment of the impact of Omalizumab in terms of efficacy, safety, and quality of life (FA-QoL) in patients with moderate/severe asthma and history of anaphylaxis to peanut, tree nuts, fish, egg, milk, and/or wheat. Evaluation of the trend of total and specific IgE during Omalizumab treatment.

Detailed description

Children (6-18 yrs) with severe asthma eligible for treatment with Omalizumab and reporting food anaphylaxis to be assessed for their concomitant food allergy. At T0: * oral food challenges (OFCs) to establish the threshold of reaction to the culprit food(s); * number and severity of food-allergic reactions in the previous 12 months recorded * Asthma Control Test * Food Allergy-Quality of Life (FA-QoL) questionnaire * total IgE * specific IgE for the culprit foods At T1 - four months after starting Omalizumab treatment: * OFCs to the previously positive foods with evaluation of the threshold of reaction * number and severity of food-allergic reactions in the previous 4 months recorded * Asthma Control Test * Food Allergy-Quality of Life (FA-QoL) questionnaire * total IgE * specific IgE for the culprit foods At T2 - eight months after starting Omalizumab treatment: * OFCs to the previously positive foods with evaluation of the threshold of reaction * number and severity of food-allergic reactions in the previous 4 months recorded * Asthma Control Test * Food Allergy-Quality of Life (FA-QoL) questionnaire * total IgE * specific IgE for the culprit foods At T1 - twelve months after starting Omalizumab treatment: * OFCs to the previously positive foods with evaluation of the threshold of reaction * number and severity of food-allergic reactions in the previous 4 months recorded * Asthma Control Test * Food Allergy-Quality of Life (FA-QoL) questionnaire * total IgE * specific IgE for the culprit foods

Conditions

• Food; Allergy, Anaphylactic Shock
• Asthma in Children

Interventions

Type	Name	Description
BIOLOGICAL	Omalizumab	Administration of Omalizumab at the doses indicated for asthma in the EMA information leaflet.

Timeline

• Start date: 2018-01-01
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2024-03-18
• Last updated: 2024-03-18

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated drug study