An Open-Label, 2-way Crossover Placebo-Controlled , Radio-Labeled Tracer Study Evaluating the Effect of MUCINEX® 1200 mg on Mucociliary and Cough Clearance From The Human Lung In Healthy, Non-Smoking Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Difference between drug and placebo in the percentage of particles cleared from the lung.
研究概览
简要总结
The purpose of this research study is to test the ability of Mucinex, an oral, over-the-counter, FDA approved expectorant) to stimulate the clearance of inhaled particles from the subject's lungs (called "mucociliary clearance"). The study will also monitor the metabolism of the drug by the subject's body.
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)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non smoker
- •BMI 19-29
- •Normal lung function
排除标准
- •Any illness
研究组 & 干预措施
Mucinex 1200mg
Pill
干预措施: Mucinex 1200mg (Drug)
Placebo
Pill
干预措施: Placebo (Drug)
结局指标
主要结局
Difference between drug and placebo in the percentage of particles cleared from the lung.
时间窗: Measurements at 60, 90 and 180 min
Difference between drug and placebo as an estimate of small airway clearance.
时间窗: Measurements at 60, 90 and 180 min
Difference between drug and placebo between study days.
时间窗: Measurements at 60, 90 and 180 min
次要结局
- Blood will be drawn to determination of guaifenesin in the serum.(at baseline and every 30 min x8)
研究者
William Bennett, PhD
Professor of Medicine
University of North Carolina, Chapel Hill