NCT01033669已完成不适用
A Randomized Cross-Over Study Investigating The Inhalation Profiles Of Four Dry Powder Inhalation Devices In Subjects With Asthma And Chronic Obstructive Pulmonary Disease.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Peak Inspiratory Flow Rate
研究概览
简要总结
Assessment of the inhalation profiles of four dry powder inhalers in patients with variable degrees of lung obstruction
详细描述
Randomized to device sequence
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a physician documented history or diagnosis of asthma for at least 6 months
- •Reversibility, defined as an increase in FEV1 at the Screening visit of greater than or equal to 12% and 200 mL
- •Subjects with a physician documented history or diagnosis of mild or severe Chronic Obstructive Pulmonary Disease
排除标准
- •Female subjects who are pregnant
- •Subjects who have a history of life-threatening asthma/COPD or who have experienced two or more exacerbations requiring hospitalization in the 12 months prior to screening
- •Evidence of lower respiratory tract infection
- •Subjects diagnosed with pulmonary fibrosis, bronchiectasis, pneumoconiosis, sarcoidosis or tuberculosis
结局指标
主要结局
Peak Inspiratory Flow Rate
时间窗: Day 3-10
次要结局
- Pressure Slope(Day 3-10)
- Peak Pressure Drop(Day 3-10)
- Time to Peak Pressure Drop(Day 3-10)
- Inhaled Volume(Day 3-10)
研究者
研究点 (1)
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