Omalizumab in Severe Asthmatics With Food Allergy

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06316414
Study type	Observational
Source	Bambino Gesù Hospital and Research Institute
Contact
Status	Completed
Phase
Start date	January 1, 2018
Completion date	March 31, 2023

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Omalizumab in Severe Asthmatics With Food Allergy — OSAFA

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms