A Randomized Controlled Trial to Investigate the (Cost)Effectiveness of Oral Immunotherapy With Different Allergens in Young Children With an Established Food Allergy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 500
- 试验地点
- 5
- 主要终点
- Cost-utility ratio at 18 months (week 78).
研究概览
简要总结
The goal of this clinical trial is to learn about oral immunotherapy in food allergic children < 30 months of age. The main question it aims to answer is: What is the clinical- and cost-effectiveness of early low-dose oral immunotherapy aimed at long-term tolerance induction. Participants will receive oral immunotherapy for 1 year with a maintenance dose of 300 mg allergenic protein and are compared with food allergic infants not receiving oral immunotherapy to compare with natural tolerance development.
详细描述
Primary objective: What is the clinical- and cost-effectiveness of early low-dose oral immunotherapy aimed at long-term tolerance induction in children under the age of 30 months with an established food allergy compared to routine care? Secondary objective: What is the effect of early low-dose oral immunotherapy in children under the age of 30 months with an established food allergy on (allergy specific) quality of life of parents and children compared to routine care? Study design: randomized controlled superiority trial Study population: Children between 9 and 30 months old with an IgE-mediated food allergy to peanut, tree nuts, cow's milk and/or hen's egg as proven by an oral food challenge. Intervention: 1-year low-dose oral immunotherapy (daily 300 mg allergenic protein) compared to strict avoidance in the control group.
Main study parameters/endpoints: Long-term tolerance as assessed by an exit oral food challenge at 4 weeks after discontinuation of the oral immunotherapy, combined with uncomplicated consumption of a full dose of the specific food at 6 months after discontinuation of the therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 9 Months 至 30 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An IgE-mediated food allergy to peanut, cashew, hazelnut, walnut, cow's milk and/or hen's egg as proven by sensitization to the specific allergen (sIgE > 0.35kU/l) and a positive oral food challenge.
- •The fore-mentioned allergens are introduced into the diet of the child (the child is tolerant for the specific allergen(s)), or the child is diagnosed with a food allergy for the specific allergen(s).
排除标准
- •(Suspected) eosinophilic oesophagitis
- •Uncontrolled asthma/ viral wheeze.
- •The inability of parents to follow instructions, recognize allergic reactions or administer emergency medication.
- •Participation in any other intervention study at the time of the OIT study, with the exception of studies on guided early introduction of highly allergenic foods.
结局指标
主要结局
Cost-utility ratio at 18 months (week 78).
时间窗: 18 months (week 78): at the end of the study period.
Incremental cost-utility ratio (ICUR) will be calculated for both groups using health-related quality of life (HRQoL) scores from the AQoL-6D (assessment of quality of life - 6 dimensions) and converted to utility scores and will be expressed in euros per QALY.
Cost-effectiveness ratio at 18 months (week 78).
时间窗: 18 months (week 78).
Incremental cost-effectiveness ratio (ICER) at 18 months (week 78). Costs associated with oral immunotherapy will be measured in Euros. Effectiveness will be considered as percentage of tolerant participants at week 78.
Percentage of tolerant participants at week 78
时间窗: week 78 = 6 months after stop of the 1-year oral immunotherapy
In children achieving sustained unresponsiveness (outcome 1), the allergen is introduced into the diet by parents at a regular base. Six months after discontinuation of the OIT, tolerance to the specific allergenic protein is assessed. Definition of tolerant: Percentage of children with uncomplicated (i.e. without any allergic symptoms) consumption at home of a full dose of the specific allergenic protein (e.g. a glass of milk or a sandwich with peanut butter).
Percentage of patients with sustained unresponsiveness to consumption of a specific allergenic food 4 weeks after stopping the 1-year oral immunotherapy (OIT)
时间窗: Timing of the OFC: week 57 (52 weeks of OIT, followed by a 4-week allergenic food-free interval)
Definition of sustained unresponsiveness: a participant who passed an oral food challenge (OFC) to 4.2 gram of the allergenic protein. Definition of the allergenic protein: the allergenic protein which induced an allergic response at an OFC at the start of the study, and was administered to the patient during the OIT (i.e. milk, egg, peanut, hazelnut, cashew or walnut).
次要结局
- Health related quality of life of children, during the 1-year OIT and six months after the therapy (week 78)(during oral immunotherapy (T=0, 26 weeks and 52 weeks), and 6 months after stopping the oral immunotherapy (78 weeks))
- Occurrence of Adverse Event(s) Related to Oral Immunotherapy up to 65 weeks study participation(during build-up (up to 3 months) and 1-year oral immunotherapy, total 65 weeks)
- Levels of allergy-related immune parameters(at start of the therapy and after 6 and 12 months maintenance therapy)
- adherence(during 1 year oral immunotherapy)
- Health related quality of life of parents, during the 1-year OIT and six months after the therapy (week 78)(during oral immunotherapy (T=0, 26 weeks and 52 weeks), and 6 months after stopping the oral immunotherapy (78 weeks))
- Occurrence of Adverse Event(s) Related to Oral Immunotherapy up to 65 weeks study participation(during build-up (up to 3 months) and 1-year oral immunotherapy, total 65 weeks)
- Levels of allergy-related immune parameters(at start of the therapy and after 6 and 12 months maintenance therapy)
- Health related quality of life of children, during the 1-year OIT and six months after the therapy (week 78)(during oral immunotherapy (T=0, 26 weeks and 52 weeks), and 6 months after stopping the oral immunotherapy (78 weeks))
- Health related quality of life of parents, during the 1-year OIT and six months after the therapy (week 78)(during oral immunotherapy (T=0, 26 weeks and 52 weeks), and 6 months after stopping the oral immunotherapy (78 weeks))
- adherence(during 1 year oral immunotherapy)
研究者
Ted Klok
Principal Investigator
Deventer Ziekenhuis