Specific Oral Immunotherapy in Food Allergy - Real-life Long-term Follow up (After Milk Oral Immunotherapy), Effect on Health-related Quality of Life and Cost-utility Analyses
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Long-term effectiveness as a measure of milk consumption (dl/day).
研究概览
简要总结
The outcomes of oral immunotherapy (OIT) in food allergy study will provide more knowledge of oral immunotherapy. So far the OIT has showed in clinical experiments to be a interesting way to increase the unresponsiveness in severe food allergies. However little is known about it´s long-term outcomes, immunological mechanisms and there are no previous studies about cost-utility of OIT.
详细描述
The purpose of the present study is to examine the outcomes of the food oral immunotherapy on patients with severe food allergy in the three different subprojects:
Study 1: Long-term follow up after milk oral immunotherapy. The measured outcomes are long-term effectiveness (e.g. health-related quality of life), safety of desensitization and immunological changes.
Study 2: Measure health-related quality of life with disease-specific and generic questionnaire. The aim of this study is to define the suitability of the FAQLQ and the 15-D questionnaires for the Finnish food allergic patients. Another purpose of this study is to examine the relationship between FAQLQ and 15-D questionnaires.
Study 3: QALYs. This is called the cost-utility analyses and QALYs and its purpose is to calculate the cost of OIT and to define the cost-effectiveness of OIT by measuring QALYs. To our knowledge this will be the first pilot study to define the QALYs in food oral immunotherapy. The aim is to have 50-100 patients. The literature in other areas of medicine 50-100 patients in QALY-publishing is quite plain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study 1: All the children have been eligible to participate milk OIT during the years 2005-
- •Study 2 + 3: Patients will start OIT treatment (to milk / egg / peanut).
排除标准
- •Not willing to participate
- •Active asthma, low lung function, pregnancy, cardiovascular or other disease that might worsen during the OIT.
结局指标
主要结局
Long-term effectiveness as a measure of milk consumption (dl/day).
时间窗: Ten years
Consumption of milk (dl/day)
次要结局
- General health-related quality of life(One year)
- Cost-utility analysis and health benefits by measuring quality-adjusted life-years (QALYs).(One year)
- Disease specific health-related quality of life(One year)
- Incidence of Treatment - Emergent Adverse Events(Ten years)
研究者
Tiina Kauppila, MD
MD
Helsinki University Central Hospital