Phase 2/3 Clinical Trial to Assess the Effect of a Sublingual Treatment Phase Prior to Oral Immunotherapy in Children With Cow's Milk Allergy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Adverse events in participants
研究概览
简要总结
Allergy to cow's milk is the most common food allergy affecting children. There is currently no accepted routine clinical therapy to cure milk allergy. Recently studies have attempted to induce desensitisation using small daily doses of cow's milk, predominantly by the oral route (oral immunotherapy, OIT). Although this therapy works for some people, its effects are not generally long lasting and it is associated with significant side effects during protocol, including potentially life-threatening allergic reactions.
Pilot data suggests that sublingual immunotherapy (SLIT, where allergen is held under the tongue, rather than swallowed) can also induce a degree of desensitisation, but with fewer adverse events. However, the degree of desensitisation induced appears to be lower than that with oral immunotherapy.
The investigators wish to determine whether a sublingual pretreatment phase can improve the safety of conventional OIT in cow's milk allergy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Allergic to 1.44g CM protein (approx. 40ml fresh milk) or less, at DBPCFC prior to randomisation
- •Informed consent of parent/legal guardian, patient assent where possible
排除标准
- •Required previous admission to an intensive care unit for management of an allergic reaction.
- •Significant symptoms of non---IgE---mediated CM allergy within the previous 12 months.
- •Children with a past history of CM allergy currently consuming CM-containing products other than extensively--heated milk in baked foods (e.g. biscuits, cakes).
- •Poorly controlled asthma within the previous 3 months (as defined by clinician judgement with reference to the ICON consensus), or asthma requiring treatment with >5 days oral corticosteroids within the previous 3 months.
- •Moderate---severe eczema, defined as requiring more than once daily application of 1% hydrocortisone as maintenance treatment despite appropriate use of emollients (eczema is not otherwise an exclusion criteria)
- •Clinically significant chronic illness (other than asthma, rhinitis or eczema)
- •History of symptoms of eosinophilic oesophagitis, irrespective of cause
- •Undergoing specific immunotherapy to another allergen and within the first year of treatment.
- •Receiving anti--IgE therapy, oral immunosuppressants, beta---blocker or ACE inhibitor.
- •Unwilling or unable to fulfil study requirements
结局指标
主要结局
Adverse events in participants
时间窗: 1 year
Proportion of participants experiencing adverse events (excluding mild, non-transient symptoms) conventional OIT to cow's milk in phase 2, in those who have received SLIT pretreatment compared to placebo.
次要结局
- Peptide microarray(12 months)
- Immunological outcomes: Allergen-specific IgE(12 months)
- Change in Health-related quality of life (HRQL) from baseline - assessed using Change in EQ-5D from baseline - after each phase of immunotherapy(15 months)
- Immunological outcomes(12 months)
- Immunological outcome: skin prick test(12 months)
- Incidence of adverse events(1 year)
- Change in self-efficacy after each phase of immunotherapy(15 months)
- Eliciting dose(mg cow's milk protein) at DBPCFC after each phase of immunotherapy(1 year)
- Change in Health-related quality of life (HRQL) from baseline - assessed using FAQLQ - after each phase of immunotherapy(15 months)
- Change in Health-related quality of life (HRQL) from baseline - assessed using FAIM - after each phase of immunotherapy(15 months)
研究者
Paul Turner
MRC Clinician Scientist, Clinical Senior Lecturer and Hon Consultant in Paediatric Allergy & Immunology
Imperial College London