NCT03927365暂停不适用
Muco-ciliary Cleansing of Lungs in COPD With and Without a Salt Particle Inhaler
Liita Care ApS2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2018年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Muco-ciliary clearance
研究概览
简要总结
Cross-over trial of the effect of a salt particle inhaler on pulmonary muco-ciliary cleansing in COPD patients as measured by lung scintigraphy.
详细描述
Stable COPD patients will be examined twice with minimum two, maximum 14 days interval. In randomized order the patients will inhale from a salt particle inhaler with (active) or without (placebo) content.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization of a salt particle inhaler devices with (active) or without (placebo) content
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD grade 1, 2 and 3 in stable condition (less than 10% change of FEV1 ratio between investigation visits
排除标准
- •Pregnant or lactating women
- •Patients exposed to radionuclear isotopes within one month
- •Patients under antibiotic treatment
- •Patients with known hyper reactive airways
结局指标
主要结局
Muco-ciliary clearance
时间窗: Activity at time 120 minutes
Retention of inhaled radioactive marker in percentage
次要结局
- Registering number of coughs(Activity at any time between time zero and 120 minutes)
- Collection of sputum(Activity at any time between time zero and 120 minutes)
- Symptoms in the subjects health(Activity at time 120)
研究者
研究点 (2)
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