NCT00540150已完成3 期
Compatibility and Immunogenicity of a Short Specific Immunotherapy (SIT) in Contrast to Classic Specific Immunotherapy in a Randomized Study Depending on Mite-Depot Supplement in Children and Adolescents With Allergic Bronchial Asthma.
Johann Wolfgang Goethe University Hospital2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2004年5月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Safety of the shortened specific immunotherapy.
研究概览
简要总结
We wanted to examine the immunogenicity and safety of a shortened specific immunotherapy in contrast to the standard specific immunotherapy.
Therefore, we challenged 12 patients for 14 weeks with the standard specific scheme and 22 patients for 6 weeks with the shortened scheme.
详细描述
see above
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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •informed consent of patient and/or parents
- •age >6 and <18 years
- •bronchial asthma I° or II°
- •allergy on house dust-mite
排除标准
- •age <6 and >18 years
- •vital capacity <80% or FEV1 <70%
- •pregnancy
- •inhalative or systemic steroid use
- •bronchial asthma III° or IV°
- •heavy exacerbation during the last 3 months
结局指标
主要结局
Safety of the shortened specific immunotherapy.
时间窗: may 2004 - march 2005
次要结局
- Exhaled nitric oxid (eNO) and immunogenicity (IgE, specific IgE, specific IgG) in both groups.(may 2004 - march 2005)
研究者
研究点 (2)
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