Omalizumab in Severe Asthmatics With Food Allergy (OSAFA)

Bambino Gesù Hospital and Research Institute

Status: Completed

Conditions: Food; Allergy, Anaphylactic Shock; Asthma in Children

Treatments: Biological: Omalizumab

Study type: Observational

Funder types: Other

Identifiers

NCT06316414

1501/17

Details and patient eligibility

About

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.

Full 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

Enrollment: 65 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No 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
• In case of female subjects of child-bearing potential, negative human chorionic gonadotropin blood sample for pregnancy testing
• No known contraindications to oral immunotherapy with food protein or Omalizumab
• Parent/legal guardian written informed consent

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)
• Subjects is on a build-up phase of standard subcutaneous immunotherapy for inhalant allergens (may be enrolled on maintenance dose)
• Inability to discontinue antihistamines for 5 half-lives prior to routine study tests (OFC)
• Subjects with weight-IgE combination yielding a dose requirement greater than 600 mg according to the EMA schedule for Omalizumab
• Systemic steroids oral, IM, or IV for indications other than asthma for more than 3 weeks in the past 6 months.

Trial design

65 participants in 1 patient group

Severe asthmatics with history of food anaphylaxis

Description:

Omalizumab will be administered i.m. with doses ranging from 150 mg every 28 days to 600 mg every 14 days, according to EMA dosing range table.

Treatment:

Biological: Omalizumab