Specific Use-Result Surveillance of Spiriva Respimat in Asthmatics (Patients With Mild and Moderate Persistent Asthma)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 193
- 试验地点
- 1
- 主要终点
- Number of Participants With Suspected Adverse Drug Reactions (ADRs)
研究概览
简要总结
The study objective is to investigate the safety and effectiveness of Spiriva Respimat in patients with mild to moderate persistent asthma under real-world use
详细描述
The study is Post-Marketing Surveillance on the Long-Term Use of Spiriva Respimat in Japanese patients with mild to moderate persistent asthma. The patient population who receive Spiriva Respimat and the safety profile is not expected to change. This study can investigate the safety and effectiveness of Spiriva Respimat in patients with mild to moderate persistent asthma under real-world use
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with mild to moderate persistent bronchial asthma
- •Patient aged ≥ 15 years
- •Patients who are naive to Spiriva Respimat and receive Spiriva Respimat for the first time for treatment of bronchial asthma on top of at least ICS treatment.
排除标准
- •Patients who have a contraindication to Spiriva Respimat defined in the package insert for Spiriva Respimat
- •Patients who have been enrolled in this study before.
研究组 & 干预措施
Spiriva Respimat group
干预措施: Spiriva Respimat (Drug)
结局指标
主要结局
Number of Participants With Suspected Adverse Drug Reactions (ADRs)
时间窗: From first drug administration until 30 days after last drug administration; up to 337 days
Number of participants with suspected adverse drug reactions (ADRs) is presented. An Adverse Event (AE) was considered to be ADR if either the physician who reported the AE or the sponsor assessed its causal relationship as related.
次要结局
- The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline(baseline and 12 weeks)