ACTRN12624000515594尚未招募Unknown
A head-to-head non-inferiority trial of low vs standard dose multi-nut oral immunotherapy in children under 6 years old.
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 208
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 1 Years 至 5 Years（—）
- 性别
- All
入选标准
- •1)Male or female children from 1 until 5 years of age (not yet turned 6)
- •2)Confirmed or highly probably allergy (as defined below) to at least one of almond, cashew, hazelnut, walnut or peanut.
- •3)Parents/guardians and subjects willing to comply with all the study requirements during their participation in the study.
- •6.2.1Tree nut allergy inclusion definitions (almond, cashew, hazelnut or walnut)
- •a)Confirmed (entry OFC required):
- •Positive skin prick test (SPT, mean wheal diameter >3mm) or specific IgE (>0.35 kU/L) at SV1 and allergic reaction to the tree nut during the entry OFC which meets the stopping criteria.
- •b)Highly probable (entry OFC not required):
- •i)Clinical history of anaphylaxis to the tree nut in the 24 months prior to SV1, with a positive SPT or sIgE at SV1, or
- •ii)Clinical history of a mild to moderate allergic reaction, with signs/symptoms meeting protocol-specified stopping criteria for OFC, to the tree nut in the 12 months prior to SV1 with a positive SPT or sIgE at SV1, or
- •iii)Allergic reaction during an oral food challenge to the nut in the 12 months prior to SV1 (performed as part of usual clinical care), with a positive SPT or sIgE at SV1, or
- •iv)For walnut only, any one of the below
- •(1) a skin prick test with mean wheal diameter >8mm in a participant who has no clinical history of reaction to walnut and is avoiding it in their diet, or
- •(2) a SPT with mean wheal diameter >6mm in a participant AND a previous clinical history of an allergic reaction to walnut prior to SV1
- •v)For cashew only, any two of the following three criteria:
- •(1)A previous clinical history of an allergic reaction to cashew prior to screening
- •(2)Cashew SPT >7mm mean wheal diameter
- •(3)Cashew component Ana o 3 specific IgE >1 kU/L
- •6.2.2Peanut allergy inclusion definitions
- •a)Confirmed (OFC required): positive peanut SPT (mean wheal diameter >3mm) or specific IgE (>0.35 kU/L) at SV1 and allergic reaction during the entry peanut OFC which meets the stopping criteria
- •b)Highly probable (OFC not required): any two of the following four criteria:
- •i)Previous clinical history of allergic reaction to peanut with signs/symptoms meeting stopping criteria
- •ii)Peanut SPT mean wheal diameter at SV1 >8mm
- •iii)Peanut sIgE at SV1 >15 kU/L
- •iv)Ara h 2 sIgE at SV1 >1 kU/L
- •c)Highly probable (OFC not required): clinical history of anaphylaxis to peanut in the 12 months prior to SV1, with a positive SPT or sIgE to peanut at SV1:
- •d)Highly probable (OFC not required): allergic reaction during an oral food challenge to peanut in the 12 months prior to SV1 (performed as part of usual clinical care), with a positive SPT or sIgE at SV1.
排除标准
- •Participants will be excluded if they meet any of the following criteria:
- •1.History of severe anaphylaxis to any nut prior to study entry, defined as a reaction causing loss of consciousness, persistent hypoxia refractory to treatment, or requiring more than three doses of IM adrenaline or intubation for management of an allergic reaction.
- •2.Use of beta-blockers
- •3.Participants currently enrolled in another clinical trial of immunotherapy for food allergy (participants who are enrolled in a follow on study after completing a previous clinical trial are not excluded).
- •4.Participants currently receiving or planning to commence sublingual immunotherapy for environmental allergens (e.g. house dust mite, grass pollens). Participants who are receiving subcutaneous immunotherapy for environmental or venom allergen desensitisation will be eligible, but OIT doses will be withheld on the day of subcutaneous immunotherapy administration.
- •5.Persistent, uncontrolled asthma. In participants with asthma, symptom control will be assessed at screening using the expert opinion-based schema in the Global Initiative for Asthma (GINA) Global Strategy for Asthma Management and Prevention, whereby uncontrolled asthma is defined as any 3 or more of the following occurring in the preceding 4 weeks
- •a)Daytime asthma symptoms for more than a few minutes, more than once a week
- •b)Any activity limitation due to asthma
- •c)Reliever medication needed more than once a week (excluding reliever taken before exercise)
- •d)Any night waking or night coughing due to asthma
- •Participants may be re-screened after asthma treatment is optimised.
- •6.Confirmed diagnosis of eosinophilic oesophagitis, and/or uncontrolled symptoms of dysphagia, postprandial abdominal pain or vomiting.
- •7.Children with other significant underlying medical conditions that place them at increased risk of adverse outcomes in the event of an allergic reaction, such as cardiovascular or respiratory diseases. The Principal Investigator or delegated study doctor will review these children and consult with the child’s usual treating specialist, and the Principal Investigator will confirm that the child is not at increased risk of harm from the study procedures by virtue of their underlying medical condition before enrolling the child in the study.
- •8.Subjects who in the opinion of the investigator will be unable to follow the protocol
研究者
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