Oral Immunotherapy for Peanut Allergy- Peanut Oral Immunotherapy (PnOIT3)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Percentage of Subjects Achieving Tolerance as Defined by a Negative DBPCFC 4 Weeks After Discontinuation of Peanut OIT Therapy.
研究概览
简要总结
Peanut allergy is known to cause severe anaphylactic reactions.The goal of this proposal is to produce a new treatment that would benefit subjects who have peanut allergy by lowering the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune response in subjects who have peanut allergy (tolerance).
详细描述
Peanut allergy is known to cause severe anaphylactic reactions. Compared with other food allergies it tends to be more persistent and also its prevalence seems to be rising. Currently there is no proven treatment other than strict avoidance. We are attempting to decrease the risk of anaphylaxis on accidental ingestion by desensitizing subjects to peanut using peanut oral immunotherapy (OIT). We are also studying the effect of peanut OIT on the peanut specific immune response to determine if tolerance to peanut protein will develop. Children ages one to six years of age with peanut allergy will be randomized to peanut OIT or placebo (active subjects). Thirty subjects will also be recruited as controls. These subjects will not receive any peanut or placebo but only have skin prick testing and lab work in addition to a history and physical exam. Active subjects will undergo a modified rush immunotherapy on the first day and then increase the doses at least every two weeks up to a maintenance dose of 4 grams (equivalent to about 13 peanuts). Doses will be taken daily at home except for dose increases which will be done on the research unit. Outcome variables of interest include response to double-blind placebo controlled food challenge, skin prick testing, peanut specific IgE, and adverse events. These results will be compared between the start and end of peanut OIT using appropriate statistical analysis.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 1- 6 years all of either sex, any race, any ethnicity at the time of the initial visit
- •The presence of IgE specific to peanuts (a positive skin prick test to peanuts (diameter of wheal >3.0 mm) and a positive in vitro IgE [CAP-FEIA] > 7 kUA/L
- •A history of significant clinical symptoms occurring within 60 minutes after ingesting peanuts
- •Provide signed informed consent
排除标准
- •History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or neurological compromise (Cyanosis or oxygen saturation < 92% at any stage, hypotension, confusion, collapse, loss of consciousness; or incontinence)
- •Currently participating in a study using an investigational new drug
- •Participation in any interventional study for the treatment of food allergy in the past 12 months
- •Subjects with a known wheat food allergy will be excluded because of cross contamination of oat with wheat
- •Poor control or persistent activation of atopic dermatitis
- •Moderate to severe persistent asthma
- •Currently being treated with greater than medium daily doses of inhaled corticosteroids, as defined by the National Heart Lung and Blood Institute (NHLBI) guidelines
- •Inability to discontinue antihistamines for skin testing and oral food challenges (OFCs)
研究组 & 干预措施
Peanut OIT
Subjects randomized to receive active treatment with peanut protein flour.
干预措施: Peanut OIT (Drug)
Placebo
Subjects randomized to receive placebo in the form of oat flour.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Subjects Achieving Tolerance as Defined by a Negative DBPCFC 4 Weeks After Discontinuation of Peanut OIT Therapy.
时间窗: 61 months for those randomized to active treatment and 73 months for those randomized to placebo for the initial 12 months of therapy
Upon completion of 60 months of peanut OIT treatment, subjects discontinued peanut OIT for 4 weeks. The primary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 5 gm peanut protein double-blind placebo controlled food challenge (DBPCPFC) without developing symptoms 4 weeks after discontinuing peanut OIT.
次要结局
- The Percentage of Subjects Achieving Full Desensitization as Defined by a Negative DBPCFC After 60 Months of Peanut OIT Therapy.(60 months for those randomized to active treatment and 72 months for those randomized to placebo for the initial 12 months of therapy)
- The Percentage of Subjects Who Are Successfully Able to Escalate up to the 4000 mg Maximum Maintenance Dose of Peanut Protein OIT During the 60 Month Desensitization Phase of the Study(approximately 40 weeks (10 months))
- The Percentage of Subjects Who Tolerated the Initial-day Escalation to 6 mg of Peanut(first day of peanut OIT dosing)
- Incidence of All Serious Adverse Events During the Study(61 months for those randomized to active peanut OIT and 73 months for those randomized to placebo for the initial 12 months of the study.)