NCT02007590已完成不适用
Does High-frequency Airflow Oscillation, Delivered Using Aerosure, Increase Exercise Capacity in Severe Chronic Obstructive Pulmonary Disease?
Actegy Ltd.2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2014年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Six minute walk distance (6MWD)
研究概览
简要总结
To investigate whether high frequency airflow oscillation (HFAO), delivered using Aerosure, increases six minute walk distance (6MWD) and reduces exertional breathlessness in patients with severe chronic obstructive pulmonary disease (COPD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable severe COPD (FEV1 < 50% predicted)
- •Modified MRC dyspnoea score 2 or greater
- •At least 10 pack year smoking history
- •Able to mobilise independently
排除标准
- •Contraindications to spirometry [1]
- •Contraindications to clinical exercise testing [2]
- •Contraindications to HFAO (see section A.6.3b))
- •Resting SpO2>88% on air or on patient's usual oxygen prescription
- •Systolic arterial blood pressure (ABP) >200mmHg, diastolic ABP >100 mmHg
- •Cooper, B.G., An update on contraindications for lung function testing. Thorax,
- •ATS/ACCP Statement on Cardiopulmonary Exercise Testing. Am. J. Respir. Crit. Care Med.,
- •167(2): p. 211-277.
结局指标
主要结局
Six minute walk distance (6MWD)
时间窗: up to 6 minutes
次要结局
- end-6MWD Borg breathlessness(after 6 minute walk test)
- Arterial oxygen saturation (SpO2)(At start of 6 minute walk test and after every 1 minute)
研究者
研究点 (2)
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