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COMPLETED

Omalizumab in Severe Asthmatics With Food Allergy

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

NCT06316414•Bambino Gesù Hospital and Research Institute

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

Eligibility

Age

6 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age 6 - 18 years
•Severe persistent allergic asthma according to the GINA guidelines
•Sensitized to a perennial aeroallergen, as witnessed by positive skin test and/or in vitro reactivity
•Symptoms inadequately controlled with inhaled corticosteroids + another medication, as witnessed by an ACT ≤ 19
•On treatment with high dose inhaled corticosteroids + another medication. Threshold dose for inhaled corticosteroids set at 400 mcg/day budesonide (or equivalent doses) for children \< 12 years, at 800 mcg/day for older patients.
•Immediate food allergy with anaphylactic symptoms within 1hr. of ingestion of milk, egg, wheat, peanut, hazelnut, and/or codfish.
•Total IgE \< 70 and \>1,500 kU/L at baseline
•Sensitivity to food allergen documented by a positive skin prick test result and/or allergen-specific IgE level, with 0.35 kU/L as a lower limit of eligibility
•Positive OFC within the past 12 months, with minimal or no reactions to the placebo challenge.
•Trained on the proper use of epinephrine
+3 more criteria

Exclusion Criteria

•Total IgE at screening \> 70 or ≤ 2,500 kUI/L
•allergy to food(s) not investigated in this study
•Immune deficiency
•Previous reaction to Omalizumab
•Previous organ transplantation
•Use of monoclonal antibodies in the previous 6 months
•Subjects with gastrointestinal or gastroesophageal disease, chronic infections, scleroderma, hepatic and gallbladder disease, chronic non-allergic pulmonary disease.
•Subjects who have received an experimental drug in the last 30 days prior to admission into this study or who plan to use an experimental drug during the study
•Pregnant or breast-feeding females.
•Subjects with food protein induced enterocolitis syndrome (FPIES)
+4 more criteria

Locations (1)

Pediatric Hospital Bambino Gesù IRCCS - Allergy Dpt

Roma, Italy

Key Dates

Start Date

January 1, 2018

Primary Completion Date

March 31, 2023

Completion Date

March 31, 2023

Last Updated

March 18, 2024

Enrollment

ACTUAL participants

Conditions

Food; Allergy, Anaphylactic ShockAsthma in Children

Interventions

Omalizumab

BIOLOGICAL

ASMact: Study on Management of Bronchial Asthma

NCT07412769

Asthma AcuteAsthma Childhood+2 more

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RECRUITINGNA

Reducing Asthma Attacks in Disadvantaged School Children With Asthma

NCT06003569

Asthma in Children

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RECRUITINGPHASE2

Soy Isoflavones For Inner City Infants At Risk For Asthma (SIRA) Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Omalizumab in Severe Asthmatics With Food Allergy

Inclusion Criteria

Exclusion Criteria

ASMact: Study on Management of Bronchial Asthma

Reducing Asthma Attacks in Disadvantaged School Children With Asthma

Soy Isoflavones For Inner City Infants At Risk For Asthma (SIRA) Study

Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)

Implementation of Asthma Community Home and School Management Program (Asthma CHAMPS)

Omalizumab Before Onset of Exacerbations