Clinical trial NCT06316414: Omalizumab in Severe Asthmatics With Food Allergy
Official title: Effects of Omalizumab on Food Allergy in Children With Severe Asthma: A Real Life Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Food; Allergy, Anaphylactic Shock
Asthma in Children
Lead sponsor: Bambino Gesù Hospital and Research Institute
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 65
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Children with severe asthma eligible for treatment with Omalizumab consecutively enrolled at the Bambino Gesu Pediatrica Hospital IRCCS in Rome
* ACT \< 20
* Food allergy as described
* History of food-induced anaphylaxis
* positive OFCs with milk, baked milk, egg, baked egg, wheat, peanut, hazelnut, codfish.

Brief 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 criteria: 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.

Primary outcomes:
measure: Milligram tolerated food allergen (gms) of raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T1.
timeFrame: Four months (T1)
Secondary outcomes:
measure: Proportion of negative OFCs at T1
timeFrame: Four months (T1)
measure: NOAEL for raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T2.
timeFrame: Eight months (T2)
measure: NOAEL for raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T3.
timeFrame: Twelve months (T3)
measure: Change in number of anaphylactic events
timeFrame: Twelve months (T3)
measure: Rate of severity of anaphylactic events
timeFrame: Twelve months (T3)
measure: Asthma Control Test (ACT)
timeFrame: Twelve months (T3)
measure: Quality of Life score
timeFrame: Four (T1), eight (T2), twelve (T3) months
measure: Total IgE
timeFrame: Four (T1), eight (T2), twelve (T3) months
measure: Specific IgE for milk, egg, hazelnut, peanut, wheat, and/or fish
timeFrame: Four (T1), eight (T2), twelve (T3) months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Pediatric Hospital Bambino Gesù IRCCS - Allergy Dpt
Study officials:
References:
citation: Fiocchi A, Artesani MC, Riccardi C, Mennini M, Pecora V, Fierro V, Calandrelli V, Dahdah L, Valluzzi RL. Impact of Omalizumab on Food Allergy in Patients Treated for Asthma: A Real-Life Study. J Allergy Clin Immunol Pract. 2019 Jul-Aug;7(6):1901-1909.e5. doi: 10.1016/j.jaip.2019.01.023. Epub 2019 Feb 20.