NCT00492076已完成4 期
A Randomised, Double-Blind Placebo-Controlled Study Assessing the Short-Term Effect of a Dermatophagoides Pteronyssinus Extract, Quantified in Mass Units, in Subjects With Perennial Mite Induced Asthma
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Reduction in inhaled corticosteroids
研究概览
简要总结
The purpose of this study is to determine whether a short course of subcutaneous immunotherapy is efficacious in mite induced asthma. The efficacy is based on reduction in control medication.
详细描述
The control of mild-moderate persistent asthma include the need of concomitant medication, as inhaled corticosteroids. However, compliance in perennial asthma is low. The aim of this study is to assess the possibility to reduce the need of concomitant medication through a short-course of subcutaneous immunotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 14 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild/moderate persistent asthma
- •Positive skin prick test or specific IgE to mites
- •Age: 14-55 years old
排除标准
- •Immunotherapy contraindications
- •Allergy to other inhalant allergens
- •Previous immunotherapy (5 years)with mites
研究组 & 干预措施
1
Active Comparator
Pangramin Plus Dermatophagoides pteronyssinus 100%
干预措施: Pangramin Plus D. pteronyssinus 100% (Biological)
2
Placebo Comparator
Pangramin Plus placebo
干预措施: Pangramin Plus D. pteronyssinus 100% (Biological)
结局指标
主要结局
Reduction in inhaled corticosteroids
时间窗: 4 months
次要结局
- Reduction in symptoms and rescue medication Tolerability(4 months)
研究者
研究点 (1)
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