NCT06316414CompletedNot Applicable
Effects of Omalizumab on Food Allergy in Children With Severe Asthma: A Real Life Study
Bambino Gesù Hospital and Research Institute1 site in 1 country65 target enrollmentStarted: January 1, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Milligram tolerated food allergen (gms) of raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T1.
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 6 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Milligram tolerated food allergen (gms) of raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T1.
Time Frame: Four months (T1)
Threshold of reactivity assessed as No Observed Adverse Events Level (NOAEL) to each of the analysed food
Secondary Outcomes
- Proportion of negative OFCs at T1(Four months (T1))
- NOAEL for raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T2.(Eight months (T2))
- Rate of severity of anaphylactic events(Twelve months (T3))
- Change in number of anaphylactic events(Twelve months (T3))
- NOAEL for raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T3.(Twelve months (T3))
- Asthma Control Test (ACT)(Twelve months (T3))
- Quality of Life score(Four (T1), eight (T2), twelve (T3) months)
- Total IgE(Four (T1), eight (T2), twelve (T3) months)
- Specific IgE for milk, egg, hazelnut, peanut, wheat, and/or fish(Four (T1), eight (T2), twelve (T3) months)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Active, not recruiting
Phase 1
Treatment with Omalizumab in food allergic childreFood Allergy with AnaphylaxisMedDRA version: 20.0 Level: LLT Classification code 10064075 Term: Seafood allergy System Organ Class: 100000004870MedDRA version: 20.0 Level: LLT Classification code 10014315 Term: Egg allergy System Organ Class: 100000004870MedDRA version: 20.0 Level: LLT Classification code 10016709 Term: Fish allergy System Organ Class: 100000004870MedDRA version: 20.0 Level: LLT Classification code 10040539 Term: Shellfish allergy System Organ Class: 100000004870MedDRA version: 20.0 Level: LLT Classification code 10001745 Term: Allergy to cow's milk System Organ Class: 100000004870MedDRA version: 20.1 Level: LLT Classification code 10034202 Term: Peanut allergy System Organ Class: 100000004870MedDRA version: 20.0 Level: LLT Classification code 10011240 Term: Cow's milk allergy System Organ Class: 100000004870MedDRA version: 20.1 Level: LLT Classification code 10054957 Term: Allergy to grains System Organ Class: 100000004870MedDRA version: 20.1 Level: LLT Classification code 10054959 Term: Allergy to nuts System Organ Class: 100000004870MedDRA version:EUCTR2018-004427-37-DKOdense Research Centre for Anaphylaxis (ORCA)100
Completed
Phase 4
Behandling af Boern Med Foedevareallergi Med Omalizumab (Xolair)Food AllergyNCT04037176Carsten Bindslev-Jensen20
Recruiting
Phase 4
Effect of Omalizumab in the Skin of Food Allergy PatientsFood Allergy in ChildrenFood AllergyNCT06618963National Jewish Health40
Recruiting
Not Applicable
Therapy monitoring of omalizumab in children and adolescents with severe allergic asthmaJ45.0Predominantly allergic asthmaDRKS00006046niversitätsklinikum Gießen und Marburg15
Active, not recruiting
Not Applicable
Combination Therapy of Omalizumab and Allergen Immunotherapy for Moderate to Severe AsthmaAllergic AsthmaNCT06771934Qianfoshan Hospital60