Safety and Efficacy of Ultra-Rush High-Dose Sublingual Immunotherapy in Children With Asthma Allergic to Grass Pollen - Prospective, Randomized, Placebo Controlled Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- clinical symptoms, reliever drugs usage, controller medication usage, lung function
研究概览
简要总结
The aim of the study is to assess the safety and efficacy of sublingual immunotherapy applied preseasonal and seasonal in ultra-rush scheme in children with bronchial asthma allergic to grass pollen. The investigators will assess clinical symptoms, reliever drugs usage, lung function, chosen markers of allergic inflammation, bronchial hyperreactivity with methacholine, and presence and type of allergy after two years of sublingual immunotherapy (SLIT) in children with asthma.
详细描述
Specific immunotherapy is the only causal treatment method of atopic diseases including bronchial asthma in children. Sublingual immunotherapy seems to be the most promising alternative to traditional specific subcutaneous injection immunotherapy.
The aim of the study is to assess the safety and efficacy of sublingual immunotherapy applied preseasonal and seasonal in ultra-rush scheme in children with bronchial asthma allergic to grass pollen. We will assess clinical symptoms, reliever drugs usage, lung function, chosen markers of allergic inflammation, bronchial hyperreactivity with methacholine, and presence and type of allergy after two years of SLIT in children with asthma.
After two years the study will be unblinded, all the children will be given grass pollen allergen extract for a year.
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
- Double (Participant, Investigator)
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
- •patients allergic to grasses pollen
- •patients with bronchial asthma
- •patients with controlled asthma
- •patients who were qualified for immunotherapy and gave written informed consent for immunotherapy
排除标准
- •patients allergic for other perennial and seasonal allergens
- •patients with other chronic diseases that either put the patient at risk when participating in the study or could influence the results of the study or the patient's ability to participate in the study as judged by the investigator
研究组 & 干预措施
1
干预措施: Staloral 300 (Drug)
2
干预措施: placebo (Drug)
结局指标
主要结局
clinical symptoms, reliever drugs usage, controller medication usage, lung function
时间窗: all visits
次要结局
- chosen markers of inflammation (specific IgE, IgG4, eosinophils)(1 month after baseline visit (second visit), after 5 months (fifth visit), after 18 months (ninth visit), after 30 months (thirteenth visit))
- skin prick test, specific nasal provocation test with grass pollen allergen(baseline visit, after 24 months (tenth visit), after 36 months (fourteenth visit))
- bronchial hyperreactivity with methacholine(after 5 months (fifth visit), after 18 months (sixth visit), after 30 months (thirteenth visit))