NCT00821418已完成不适用
Assessment of the Safety and the Effect on Patients With COPD of Treatment With PulseHaler™ - a Novel Device for Pulsating Positive Expiratory Pressure Ventilation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pulmonary function tests
研究概览
简要总结
The purpose of the study is to assess the safety and the effect of treatment by PulseHaler™ on patients with COPD, as measured by the change from baseline in full pulmonary functions, oxygen saturation, exercise tolerance and health related quality of life; and to assess the ease of use of PulseHaler™ by the patients.
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
- •Diagnosis of COPD
- •Diagnosis established for at least 1 year;
- •Post-bronchodilator FEV1/FVC < 0.7
- •Post bronchodilator FEV1 <70% predicted
- •Age: 40 years or older
- •Smoking cigarettes, at least 10PY
- •Patient signed the informed consent form
排除标准
- •Bullous Emphysema (ruled out by recent CT)
- •Hospitalization due to exacerbation of COPD within the last 3 months
- •Upper respiratory infection and/or exacerbation of COPD in the last 4 weeks
- •Systemic steroid treatment in the last 4 weeks
- •Women at the age of fertility, who are pregnant, or plan pregnancy, or do not use contraceptive.
- •Severe cardiac disease, e.g., CHF grade 3 or higher
- •Acute MI within last 3 months
- •CABG within last 3 months
- •Other severe systemic disease
研究组 & 干预措施
PulsHaler first
Experimental
干预措施: PulseHaler treatment (Device)
Placebo first
Placebo Comparator
干预措施: CPAP treatment (through a deactivated version of PulsHaler) (Device)
结局指标
主要结局
Pulmonary function tests
时间窗: Within 2 hours from first treatment, and after 2 weeks of treatment
Six minute walk test
时间窗: Within 2 hours from first treatment, and after 2 weeks of treatment
Health related quality of life
时间窗: Within 2 hours from first treatment, and after 2 weeks of treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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