NCT02489981已完成不适用
Specific Use-result Surveillance of Spiriva Respimat in Asthmatics (Patients With Severe Persistent Asthma)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 359
- 试验地点
- 1
- 主要终点
- Percentage of Patients With Suspected Adverse Drug Reactions (ADRs)
研究概览
简要总结
The safety of Spiriva® 2.5 µg Respimat® 60 puffs (hereinafter referred to as Spiriva® Respimat®) in patients with severe persistent asthma under the real-world use was not confirmed in clinical trials.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Spiriva
Patients with severe persistent asthma
干预措施: Spiriva (Drug)
结局指标
主要结局
Percentage of Patients With Suspected Adverse Drug Reactions (ADRs)
时间窗: Week 52
Percentage of patients with ADRs are presented. There was no primary outcome for effectiveness as the primary objective of the surveillance is the evaluation of safety.
次要结局
- Change From Baseline in Asthma Control Status at Week 52(Baseline and Week 52)
研究者
研究点 (1)
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