Comparison of the Airway Clearance Efficacy of Electro Flo 5000 and the G5 Flimm-Fighter in Patients With Cystic Fibrosis (CF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- Wet Sputum Weight
研究概览
简要总结
It is the goal of the proposed study to compare the efficacy, as assessed primarily by sputum weight, of these two different devices (the Electroflo 500 and the G5 Flimm-Fighter) for airway clearance (AC) in CF patients with mild to moderate lung disease, who have stable lung health and perform AC at home as part of their routine therapeutic regimen.
详细描述
The investigators hope to enroll 25 patients with cystic fibrosis (with daily sputum production) in this study. It is the goal of the proposed study to compare the efficacy, as assessed primarily by sputum weight, of these two different devices (the Electroflo 500 and the G5 Flimm-Fighter) for airway clearance (AC) in CF patients with mild to moderate lung disease, who have stable lung health and perform AC at home as part of their routine therapeutic regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of CF established by standard criteria (sweat chloride > 60 mmol/L and/or two alleles affected by gene mutations know to be associated with CF).
- •Age older than 8 years.
- •Known to consistently produce sputum.
- •Currently on a home therapeutic regimen that includes some form of AC performed at least 1 time daily.
- •FEV1 > 30%-predicted, and with stable lung function
排除标准
- •Hospitalization for CF pulmonary complications in the 1 months preceding enrollment.
- •Hemoptysis > 60 cc in a single episode in the 4 weeks preceding enrollment.
- •Chronic chest pain.
- •Participation in another interventional clinical trial in the previous 30 days.
结局指标
主要结局
Wet Sputum Weight
时间窗: End of study visit per intervention
To compare the wet to dry weight of study patients' sputum collected during their Day 1 \& Day 2 therapy sessions.
Dry Sputum Weight
时间窗: End of study visit per intervention
To compare the wet to dry weight of study patients' sputum collected during their Day 1 \& Day 2 therapy sessions.
Pulmonary Function Measured as a Percent Predicted AFTER Therapy With Either ElectroFlo 5000 / G5.
时间窗: End of study visit per intervention
Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 \& Day 2 therapy sessions. Will also compare the results based on the therapies they receive.
次要结局
- PRO (Patient-reported Outcome)(End of study visit per intervention)
- Pulmonary Function Measured as a Percent Predicted BEFORE Therapy With Either ElectroFlo 5000 / G5.(End of study visit per intervention)
研究者
Carlos Milla
Associate Professor of Pediatrics
Stanford University