NCT06254664已完成1 期
Open Label Study to Assess the Effect of Patient Use and Robustness of Tiotropium 18ug Inhalation Powder, Hard Capsule, Zephir Inhaler Device
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Xiromed LLC
- 入组人数
- 116
- 试验地点
- 9
- 主要终点
- In vitro Measurement of Emitted Dose
研究概览
简要总结
An Open Label Study to Assess the Effect of Patient Use and Robustness of Tiotropium 18ug Inhalation Powder, Hard Capsule, Inhaler Device. Zephir inhaler robustness will be assessed by in vitro testing of the Zephir inhaler after 12 weeks of patient use
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（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
Tiotropium 18 µg inhalation powder, hard capsule once daily (QD)
Experimental
Interventions:
Drug: Tiotropium 18 µg inhalation powder, hard capsule
Device: Zephir inhaler
干预措施: Tiotropium 18 µg inhalation powder, hard capsule (Drug)
Tiotropium 18 µg inhalation powder, hard capsule once daily (QD)
Experimental
Interventions:
Drug: Tiotropium 18 µg inhalation powder, hard capsule
Device: Zephir inhaler
干预措施: Zephir inhaler (Device)
结局指标
主要结局
In vitro Measurement of Emitted Dose
时间窗: 3 weeks
次要结局
未报告次要终点
研究者
研究点 (9)
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