NCT01187589已完成不适用
Preliminary Assessment of the Effect of PulseHaler™ With Albuterol on Lung Deposition of Aerosol and on Pulmonary Functions in COPD Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Lung deposition
研究概览
简要总结
This study is aimed at finding the effect of PulseHaler™ with Albuterol on Lung Deposition of Aerosol and on Pulmonary Functions in COPD 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), established for at least 1 year
- •Post-bronchodilator FEV1/FVC < 0.7
- •Post-bronchodilator FEV1 in the range 30% - 70% predicted
- •Age: 40 years or older
- •Patient signed the informed consent form
排除标准
- •Pneumothorax in the past, per anamnesis.
- •Women at the age of fertility, who are pregnant, or plan pregnancy, or do not use contraceptive.
- •Severe cardiac disease, e.g., Congestive Heart Failure (CHF) grade 3 or higher
- •Coronary Artery Bypass Graft (CABG) or Acute Myocardial Infarction (MI) within last 3 months
- •Other severe systemic disease
- •Non-cooperative or non-compliant patient
研究组 & 干预措施
Pulsehaler
Experimental
Fully operational Pulsehaler, with protocol enabled
干预措施: Pulsehaler (Device)
Pulsehaler
Experimental
Fully operational Pulsehaler, with protocol enabled
干预措施: Nebulizer & Albuterol 0.5ml (Drug)
Nebulizer
Active Comparator
Deactivated Pulsehaler (protocol disabled), so only the nebulizer is active
干预措施: Nebulizer & Albuterol 0.5ml (Drug)
结局指标
主要结局
Lung deposition
时间窗: 1 hour
Lung deposition of the albuterol-containing aerosol
Pulmonary functions
时间窗: 1 hour
Pulmonary function tests by spirometry
次要结局
- Dyspnea(1 hour)
研究者
研究点 (1)
Loading locations...
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