Comparative Analysis Between Two Oral Immunotherapy Schemes in Cow´s Milk and/or Hen´s Egg Allergic Children to Improve Treatment Efficiency and Identify Response Biomarkers. CompITO Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of adverse events with an oFASS5 severity ≥2 occurred until Induction Phase (Part 1) completion at the hospital setting per subject in both groups, rush vs conventional
研究概览
简要总结
This study investigates the efficacy and safety of two different OIT schemes to treat milk and egg allergic children
详细描述
Food immunotherapy, especially oral immunotherapy (OIT), is now a standard treatment option for patients allergic to cow´s milk, hen´s egg or peanuts. While peanut OIT has drawn considerable attention from the scientific community, milk and hen´s egg OIT still remain as the most common immunotherapy administered in daily routine. Optimization of these treatments is a priority to offer to a wider number of candidates a more efficient and safe way of treatment.
A Phase II/III randomized clinical trial enrolling a total of 40 patients with non-severe food allergies (20 cow's milk allergic children and 20 hen's egg allergic children) to assess the safety and efficacy of a rush/rapid versus a conventional OIT protocol.
Schemes are comparable in terms of the number of doses, the relative increment between doses and the final amount of protein, with one exception: the "rush" regimen includes several doses given the same day over the first week of treatment while in the "conventional" regimen Induction Phase is based upon single doses given every 2 weeks.
There are two different parts in the study, during Induction Phase (Part 1, 1 week up to 7 months), participants in both groups will receive incremental doses of milk/egg, depending on their allergy, until they tolerate 6600 mg or 4680mg of milk or egg protein respectively. The occurrence of adverse events in both groups will result in dose adjustments and delay in completion Induction Phase. During Maintenance Phase (Part 2), patients will ingest the same dose (daily for milk and every 48h for egg) until the end of study, that will last for a total duration of 7 months.
The study features a dual primary outcome. Safety and efficacy variables are primary outcomes, and parents and patient-reported food allergy-related quality of life (HRQoL) are secondary outcomes, as well as burden of treatment and immunological changes. Molecular changes underlying OIT will be studied, and biomarkers of safety and efficacy will be sought
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
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 6 to 16 years old
- •sIgE levels to milk 0.35 to 35kUA/L for milk allergic subjects and egg 0.35 to 35kUA/L for egg allergic subjects
- •Entry DBPCFC discrete milk eliciting dose (ED)≥ 22.2mg of milk protein and discrete egg ED≥18.5mg of egg protein, that are the population-based reference values for the ED20
- •Having a mild to moderate food allergy severity per DEFASE score (<13 points)
排除标准
- •sIgE levels to milk >35kUA/L for milk allergic subjects and egg > 35kUA/L for milk allergic subjects
- •Entry DBPCFC discrete milk ED<22.2mg of milk protein or discrete egg ED<18.5mg of egg protein
- •Entry DBPCFC discrete ED for milk>2112mg of milk protein (cumulative amount of 4193,7mg of milk protein) and egg discrete ED>1560mg of egg protein (cumulative amount of 3110.8mg of egg protein)
- •Having severe food allergy per DEFASE score (≥13 points)
- •Other exclusion criteria: uncontrolled asthma, FEV1<70%, severe atopic dermatitis, Eosinophilic Esophagitis, non-IgE mediated allergy, having started SCIT 3 months before, or SLIT one week before. Pregnancy
研究组 & 干预措施
Rush protocol
Milk and egg allergic children undergoing OIT following a Rush regimen
干预措施: "Rush" regimen (Biological)
Conventional protocol
Milk and egg allergic children undergoing OIT following a Conventional regimen
干预措施: "Conventional" regimen (Biological)
结局指标
主要结局
Number of adverse events with an oFASS5 severity ≥2 occurred until Induction Phase (Part 1) completion at the hospital setting per subject in both groups, rush vs conventional
时间窗: Throughout the Induction Phase (Part 1), 1 week up to 7 months
Proportion of subjects completing the Induction Phase (Part 1) in both groups (rush vs conventional) at the end of study (7 months of treatment)
时间窗: End of study (7 months of treatment)
次要结局
- Number of adverse events with an oFASS5 severity ≥2 reported until Induction Phase (Part 1) completion at home and hospital setting per subject in both groups, rush vs conventional(Throughout the Induction Phase (Part 1), 1 week up to 7 months)
- Number of anaphylaxis events reported until Induction Phase (Part 1) completion at home and hospital setting per subject in both groups, rush vs conventional(Throughout the Induction Phase (Part 1), 1 week up to 7 months)
- Comparison of the median threshold change between baseline double blind placebo-controlled food challenge (DBPCFC) and maximum tolerated dose (mg of protein) between rush and conventional protocol subjects at the end of the study (7 months of treatment)(End of study (7 months of treatment))
- Comparison of the median number of days needed in both groups, rush vs conventional, to complete the Induction Phase (Part 1) in subjects accomplishing this outcome(Throughout the Induction Phase (Part 1), 1 week up to 7 months)
- Comparison of the median Food Allergy Quality of Life Questionnaire, Parental Form (FAQLQ-PF) score change in patients undergoing rush vs conventional protocols between baseline and end of study (7 months of treatment).(End of study (7 months of treatment))
- Comparison of the median burden of treatment score in patients undergoing rush vs conventional protocols at the end of study (7 months of treatment)(End of study (7 months of treatment))
- Comparison of the median sIgE levels (kU/L) to milk or egg proteins in patients undergoing rush vs conventional protocols at baseline and at end of study (7 months of treatment)(End of study (7 months of treatment))
- Comparison of the median SPT (mm) wheal size to milk or egg proteins in patients undergoing rush vs conventional protocols at baseline and at end of study (7 months of treatment)(End of study (7 months of treatment))
- Comparison of the median sIgG4 (mg/L) levels to milk or egg proteins in patients undergoing rush vs conventional protocols at baseline and at end of study (7 months of treatment)(End of study (7 months of treatment))
研究者
Pablo Rodríguez del Rio
Sponsor-Investigator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa