Mucociliary Clearance in Healthy Subjects: Comparison of Levalbuterol and Racemic Albuterol
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Lung mucociliary clearance
研究概览
简要总结
The purpose of this study is to determine whether lung mucociliary clearance (MCC) can be significantly enhanced in healthy subjects by one week of inhalation of nebulized levalbuterol aerosol, as compared to racemic albuterol or placebo. Subjects will inhale one week of levalbuterol, one week of racemic albuterol, and one week of placebo, in a randomized order.
详细描述
In healthy lungs, inhaled insoluble material such as bacteria, viruses, antigens, and toxins deposit in the tracheobronchial airway mucus and are removed from the lung in a matter of hours by mucociliary clearance (MCC). When MCC is overwhelmed or impaired, some mucus can be removed by mechanical or cough clearance (CC). Impairment of MCC typically leads to the accumulation of mucus in the airways, and this in turn is associated with acute infections, chronic bacterial colonization, and chronic inflammation.
Racemic albuterol has been shown to stimulate MCC in various patient populations. Inhaled and subcutaneous terbutaline has also been shown to stimulate MCC in healthy subjects. We hypothesize that levalbuterol will be more potent than racemic albuterol in enhancing MCC and CC in healthy subjects.
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
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •non-smoking males and non-pregnant females greater than or equal to 18 years of age
- •forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) greater than or equal to 80% of predicted values
- •normal systolic and diastolic blood pressures
排除标准
- •history of heart disease, irregular heartbeat, hypertension
- •history of diabetes, hyperthyroid
- •history of pneumonia, tuberculosis
- •history of seizure disorder, depression, hospitalization in the last month for non-elective purposes, cold or flu in the previous three months
结局指标
主要结局
Lung mucociliary clearance
Lung cough clearance
次要结局
- Forced expiratory volume in 1 second
- Forced vital capacity
