NCT00413556已完成3 期
Randomised, Double-Blind, Placebo-Controlled Phase IIIb Study Investigating Changes in Immunological Parameters and Cutaneous Reactivity Induced by a Short Course Immunotherapy With ALK Grass Tablets
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Difference in serum leves of IgG4
研究概览
简要总结
We plan to determine changes in the immune system during the allergic response to grass pollen allergens. We have chosen a particular element of the immune response, the immunoglobulin G4 (IgG4) as an indicator.
We hypothesize that treatment with Grazax will increase serum levels of Phleum pratense specific IgG4 and IgE, as well as reduce the cutaneous sensitivity of the early (IgE mediated) and late (cell mediated) allergic response.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A history of grass pollen allergy
- •Positive skin prick test to grass
- •Positive specific IgE to grass
排除标准
- •Treatment with anti-IgE
结局指标
主要结局
Difference in serum leves of IgG4
时间窗: 6 months
次要结局
- Changes in IgE level(6 months)
- Changes in cutaneous response(6 months)
研究者
研究点 (2)
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