Inspiratory Flow Parameters With Placebo Tiotropium Easyhaler® and Placebo Spiriva® Capsule Via HandiHaler® in Patients With COPD and in Healthy Volunteers. Substudy: Easyhaler® and HandiHaler® Usability Study in Patients With COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The primary variable will be the PIF rate through the Easyhaler and HandiHaler inhalers.
研究概览
简要总结
The study will characterise inspiratory flow parameters across placebo dry powder inhaler Easyhaler (2 inhaler versions) and placebo Spiriva inhalation powder capsule inhaled via HandiHaler in patients with chronic obstructive pulmonary disease (COPD) and in healthy volunteers.
Substudy: Easyhaler® and HandiHaler® Usability study in patients with COPD; to assess patients acceptability, preference, correct use and ability to learn to use Easyhaler and HandiHaler (with capsules) and to compare PIF rate via In-Check Dial meter with the PIF rate via spirometer in the main study.
详细描述
This is an open, randomised, multicentre, crossover study with Easyhaler and HandiHaler inhalers. The primary objective is to characterise inspiratory flow parameters across placebo dry powder inhaler Easyhaler (2 inhaler versions) and placebo Spiriva inhalation powder capsule inhaled via HandiHaler in patients with chronic obstructive pulmonary disease (COPD) and in healthy volunteers. The secondary objective is to calculate correlation of peak inspiratory flow (PIF) rate with regards to anthropometric and lung function parameters.
Substudy: This is an open, randomised, multicentre, crossover study with Easyhaler and HandiHaler inhalers.There will be 1 study visit per subject, usually this visit is done at the same visit with the main study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Inhaler B, Tiotropium Easyhaler
Placebo Tiotropium Easyhaler, type B
干预措施: Placebo Tiotropium inhalation powder type B (Drug)
Inhaler A, Tiotropium Easyhaler
Placebo Tiotropium Easyhaler, type A
干预措施: Placebo Tiotropium inhalation powder type A (Drug)
Reference product, Spiriva modified HandiHaler
Placebo Spiriva, hard capsule inhaled via modified HandiHaler device
干预措施: Placebo Spiriva capsule (Drug)
Substudy Test product Placebo Tiotropium Easyhaler
The substudy subjects will demonstrate the use of the inhaler.
干预措施: Substudy Placebo Tiotropium Easyhaler (Device)
Substudy Reference product Placebo Spiriva® HandiHaler
The substudy subjects will demonstrate the use of the inhaler.
干预措施: Substudy Placebo Spiriva® via HandiHaler (Device)
结局指标
主要结局
The primary variable will be the PIF rate through the Easyhaler and HandiHaler inhalers.
时间窗: 1 day
After practising, 3 inspiratory flow curves will be recorded and the inhalation with the highest PIF rate analysed.
次要结局
- Inspiratory volume through the Easyhaler and HandiHaler inhalers(1 day)