NCT07567690进行中（未招募）不适用
A Prospective Observational Study of Biologic Treatment and Outcomes in Patients With Severe Asthma (BREATH)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of participants experiencing at least one asthma exacerbation
研究概览
简要总结
This study aims to evaluate the immunogenicity of the drug by measuring anti-drug antibody (ADA) formation and titers. The presence of ADAs will be assesses to determine their potential impact on the drug's efficacy and safety.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with severe asthma
排除标准
- •History of hypersensitivity reactions to biologics (anti IL5 or IL5Ra)
研究组 & 干预措施
Patients with severe asthma
结局指标
主要结局
Number of participants experiencing at least one asthma exacerbation
时间窗: 12 month
Number of participants experiencing at least one asthma exacerbation
Annualized rate of clinically significant asthma exacerbations
时间窗: 12 month
Annualized rate of clinically significant asthma exacerbations
次要结局
未报告次要终点
研究者
Noeul KANG
Principal Investigator
Samsung Medical Center
研究点 (1)
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