Omalizumab in Severe Asthmatics With Food Allergy

Asthma in Children Clinical Trial

— OSAFA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06316414
• Other study ID #: 1501/17
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: March 31, 2023

Study information

• Verified date: March 2024
• Source: Bambino Gesù Hospital and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anaphylaxis
• Asthma
• Asthma in Children
• Food Hypersensitivity
• Hypersensitivity

Intervention

Biological:
• Omalizumab
Administration of Omalizumab at the doses indicated for asthma in the EMA information leaflet.

Locations

Country	Name	City	State
Italy	Pediatric Hospital Bambino Gesù IRCCS - Allergy Dpt	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Bambino Gesù Hospital and Research Institute

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Milligram tolerated food allergen (gms) of raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T1.	Threshold of reactivity assessed as No Observed Adverse Events Level (NOAEL) to each of the analysed food	Four months (T1)
Secondary	Proportion of negative OFCs at T1	Percentage of OFC tolerated until the last dose of food.	Four months (T1)
Secondary	NOAEL for raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T2.	Change in the NOAEL at the third OFC to the foods who did not pass the OFC at T1	Eight months (T2)
Secondary	NOAEL for raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T3.	Change in the NOAEL at the fourth OFC to the foods who did not pass the OFC at T2	Twelve months (T3)
Secondary	Change in number of anaphylactic events	Number of episodes of anaphylaxis in the 6 - 12 months preceding T0 compared with those 6 - 12 months after the first dose of Omalizumab	Twelve months (T3)
Secondary	Rate of severity of anaphylactic events	Severity of episodes of anaphylaxis in the 6 - 12 months preceding T0 compared with those 6 - 12 months after the first dose of Omalizumab; PRACTALL score: 1 - mild, 2 - moderate, 3 - severe.	Twelve months (T3)
Secondary	Asthma Control Test (ACT)	Change from baseline in ACT score: 5 worse, 25 better outcome	Twelve months (T3)
Secondary	Quality of Life score	Change from baseline in age-appropriate FA-QoL score: 0, better; 84, worse outcome	Four (T1), eight (T2), twelve (T3) months
Secondary	Total IgE	Change from baseline in total IgE	Four (T1), eight (T2), twelve (T3) months
Secondary	Specific IgE for milk, egg, hazelnut, peanut, wheat, and/or fish	Change from baseline in sIgE;	Four (T1), eight (T2), twelve (T3) months