NCT00410930终止2 期
Double-Blind Placebo-Controlled Study of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Reduction of symptom and medication scores.
研究概览
简要总结
To compare versus placebo the efficacy and safety of recombinant Bet v1, natural purified Bet v1 and birch pollen licenced extract used for 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
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-50 with seasonal rhinoconjunctivitis for at least 2 years, and/or mild asthma range 1 and 2 GINA.
- •Positive history of birch pollen allergy (clinical history, positive skin prick test, birch specific IgE, presence of birch pollen)
- •Compliant patients
- •Written consent.
排除标准
- •Perennial rhinoconjunctivitis and/or asthma due to cosensitization with: animal danders, mites, alternaria cladosporium
- •Uncontrolled seasonal asthma : severe asthma permanent or not range 3 and 4 of GINA.
- •Patients treated with beta-blockers or under continuous oral corticosteroids.
- •Pregnant women
结局指标
主要结局
Reduction of symptom and medication scores.
次要结局
未报告次要终点
研究者
研究点 (2)
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