Phase 2 Randomised Study of Oral Immunotherapy Using Boiled Peanut to Induce Desensitisation in Children With Challenge-proven, IgE-mediated Peanut Allergy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Desensitisation to >1.4g (Roasted) Peanut Protein at Food Challenge
研究概览
简要总结
Peanut allergy is increasingly common, especially in countries such as UK and Australia. There is currently no accepted routine clinical therapy to cure peanut allergy. Recently studies have looked at desensitising people with peanut allergy by giving them small daily doses of roasted peanut. Although this therapy works for some people, its effects are not generally long lasting and it is associated with many side effects during protocol, resulting in a significant rate of drop-outs.
Pilot data suggests that boiled peanut is less immunogenic than roasted peanut, and may therefore provide a safer way of inducing desensitisation in patients who are allergic to roasted peanut, by first inducing tolerance to boiled peanut.
Study hypothesis: Increasing doses of boiled peanut can induce desensitisation to roasted peanut, in peanut-allergic individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IgE-mediated peanut allergy, confirmed at double-blind placebo-controlled food challenge
- •Tolerant to at least 1/4 boiled peanut (boiled for 4 hours) at open food challenge.
- •Informed consent of parent/legal guardian and patient assent
排除标准
- •Allergic to 1/4 boiled peanut at PCFC
- •Tolerates ≥1.4 g roasted peanut protein at entry PCFC
- •Unstable asthma
- •Unwilling or unable to fulfil study requirements
- •Undergoing other forms of immunotherapy (e.g. SCIT or SLIT to aeroallergens)
- •Previous admission to ICU for management of allergic reaction to peanut
- •Clinically significant chronic illness (other than asthma, rhinitis or eczema).
- •Undergoing subcutaneous or sublingual immunotherapy and within the first year of therapy, for respiratory allergy.
- •Subjects receiving anti-IgE therapy, oral immunosupressants, beta-blocker or ACE inhibitor therapy.
结局指标
主要结局
Desensitisation to >1.4g (Roasted) Peanut Protein at Food Challenge
时间窗: 12 months
The proportion of participants who tolerate 1.4g (or more) roasted peanut protein after 12 months of OIT as assessed by DBPCFC, in the active vs control group.
次要结局
- Sustained Unresponsiveness After 4 Week Cessation of Maintenance OIT(After 1 year of OIT)
- Study Compliance(12 months)
- Safety, Incidence of Adverse Event(12 months)
- Quality of Life Measures(6, 12 and 24 months)
- Change in Threshold to Roasted Peanut After 6 and 12 Months of OIT(6 and 12 months after study intervention)
- Immunological Outcomes(Pre, 3, 6, and 12 months post start of OIT)
研究者
Paul Turner
Principal Investigator
Imperial College London