NCT02753712已完成3 期
A Two-arm, Randomised, Assessor-blind, Parallel Group Study to Evaluate the Effect of Fluticasone/Formoterol Breath Actuated Inhaler (BAI) and Relvar® Ellipta® DPI on Ventilation Heterogeneity in Subjects With Partially Controlled or Uncontrolled Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 16
- 主要终点
- Measuring peripheral airway resistance (R5-R20)
研究概览
简要总结
The purpose of this study is to demonstrate improvement of peripheral airway resistance (R5-R20) from baseline with fluticasone/formoterol breath actuated inhaler (BAI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（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
fluticasone/vilanterol DPI (Relvar Ellipta DPI)
Active Comparator
Inhalation powder. 92/22µg, I inhalation od
干预措施: Fluticasone/Vilanterol DPI (Relvar Ellipta DPI) (Drug)
Fluticasone/formoterol BAI
Experimental
Pressurised suspension for inhalation 125/5µg, 2 inhalations bid
干预措施: Fluticasone/Formoterol BAI (Drug)
结局指标
主要结局
Measuring peripheral airway resistance (R5-R20)
时间窗: From baseline to week 8
Measuring peripheral airway resistance (R5-R20)
次要结局
- Measuring distal airway volume and resistance (using impulse oscillometry)(From baseline to week 8 and 9)
- Evaluate asthma control (using ACQ-6) )(From baseline to week 4 and 8)
- Evaluate health status (using AQLQ)(From baseline to week 4 and 8)
- measure ventilation heterogeneity (using Functional Respiratory Imaging)(From baseline to week 9)
研究者
研究点 (16)
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