临床试验/NCT06316414

NCT06316414已完成不适用

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

Bambino Gesù Hospital and Research Institute1 个研究点分布在 1 个国家目标入组 65 人开始时间: 2018年1月1日最近更新: 2024年3月18日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 65
试验地点: 1
主要终点: Milligram tolerated food allergen (gms) of raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T1.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型: Observational
观察模型: Case Only
时间视角: Prospective

入排标准

年龄范围: 6 Years 至 18 Years（Child, Adult）
性别: All
接受健康志愿者: 否

入选标准

•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

排除标准

•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.

结局指标

主要结局

Milligram tolerated food allergen (gms) of raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T1.

时间窗: Four months (T1)

Threshold of reactivity assessed as No Observed Adverse Events Level (NOAEL) to each of the analysed food

次要结局

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)

研究者

发起方

Bambino Gesù Hospital and Research Institute

申办方类型

Other

责任方

Sponsor

研究点 (1)

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