JPRN-jRCT2080221805未知2 期
Phase II/III Clinical Trial of TO-203 -Efficacy and Safety Trial in Patients with HDM-induced Asthma
试验速览
- 阶段
- 2 期
- 入组人数
- 900
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 64age old（—）
- 性别
- All
入选标准
- •(1) HDM-specific IgE antibodies >= Class 3
- •(2) Positive HDM-allergen scratch or prick test
- •(3) Asthmatic symptoms were treated with ICS
- •(4) Dicumented reversible airway obstruction
- •(5) FEV1 > 70% of the predicted value
排除标准
- •(1) Patients who have perennial symptoms of asthma or rhinitis due to regular exposure to antigens (excluding HDM).
- •(2) Patients who received immunotherapy with HDM allergen-containing products (e.g., house dust) for at least 1 month during 5 years before the first day of observation.
- •(3) Patients who are on immunotherapy other than HDM allergen-containing products on the first day of observation.
- •(4) Patients with a history of serious adverse drug reactions due to immunotherapy.
- •(5) Patients who were hospitalized due to worsening of asthma within 3 months before the first day of observation.
研究者
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