A Proof of Principal Randomized Controlled Eight-Week Study of the Safety and Efficacy of the Lung Flute in Adults With Chronic Obstructive Pulmonary Disease. A FDA 510(k) Equivalency Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Safety and Efficacy of the Lung Flute Versus the Acapella for the Treatment of COPD in Adults. Twenty-four (24) Hour Dry Sputum Weight
研究概览
简要总结
This is an eight-week, randomized, controlled, two arm parallel study. The study consists of, a screening visit, two weeks of intervention-free run-in randomization, clinic visits week 0, 1, 2, 4, 6, and 8 weeks during the intervention period to collect 24 hour sputum and to confirm techniques of device use and entries into daily diaries. Twenty-four (24) hour sputum samples will be collected and weighed at each clinic visit. In addition to clinic visits, subjects will be expected to make daily diary entries of COPD symptoms. Clinical evaluation will include adverse event surveillance, and St. Georges Respiratory questionnaire.
详细描述
No further details
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age of over 40 with COPD
排除标准
- •Children,
- •New mothers; and
- •Women intending to become pregnant
结局指标
主要结局
Safety and Efficacy of the Lung Flute Versus the Acapella for the Treatment of COPD in Adults. Twenty-four (24) Hour Dry Sputum Weight
时间窗: 8 weeks
In order to test the overall treatment effect on dry sputum weight over the course of the study, mixed effects analysis were performed. These models allow us to account for the longitudinal nature of the data. We assumed that the observations collected within each patient were correlated; however, observations collected across patients were assumed to be independent. Dry sputum weights obtained prior to and at randomization were regarded as baseline measurements, while those obtained at week 1, 2, 4, 6 and 8 were examined for treatment effects.
次要结局
- FEV1 - Baseline and Device Comparisons(8 weeks)
- Quality of Life Questionnaire/Daily Diary(8 weeks)
- Change in CCQ Score(8 weeks)