Impact of Lung Flute Therapy on Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Impact of Lung Flute Therapy on Asthma
研究概览
简要总结
We hypothesized that the ability of the Lung Flute to enhance mucus clearance from the lower airways could be used to improve asthma control, if the device is used on a chronic basis. The primary end point of the study is the comparison of Asthma Control Test (ACT) - a validated questionnaire for asthma control and exhaled NO before, during and after using the lung flute. Several secondary end points were assessed for efficacy and safety, including health status, spirometric lung function, "stepping down" controller therapy and daily albuterol use.
详细描述
This is a 3 month open label study. We plan to enroll 48 subjects with asthma at the Buffalo General Medical Center Allergy Clinic or the office of Dr. James Cumella. Inclusion criteria includes: at least 12 years of age, diagnosis of asthma and no current or previous history of smoking. Exclusion criteria includes: exacerbation of asthma or hospitalization for asthma within 8 weeks prior to enrollment, predominant chronic obstructive pulmonary disease (COPD) and bronchiectasis by clinical and/or radiological assessment, history of cough syncope, pregnant or nursing women, and inability to comply with study procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 12 years of age
- •diagnosis of asthma and no current or previous history of smoking.
排除标准
- •exacerbation of asthma or hospitalization for asthma within 8 weeks prior to enrollment
- •predominant COPD and bronchiectasis by clinical and/or radiological assessment
- •history of cough syncope
- •pregnant or nursing women
- •not fluent in English
- •inability to comply with study procedures.
结局指标
主要结局
Impact of Lung Flute Therapy on Asthma
时间窗: three months
improvement in quality of life as measured by the validated Asthma Control Test (ACT);
次要结局
- Impact of Lung Flute on Asthma(three months)