Evaluation of the Effectiveness of The Volara System Determined by Sputum Movement and Production
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in mucus plug volume (mL)
研究概览
简要总结
The aim of this study is to evaluate the therapeutic effect of therapy with The Volara System on mucus clearance.
详细描述
The aim of this study is to evaluate the therapeutic effect of therapy with The Volara System on mucus clearance. Mucus volume (mL) measured by Functional Respiratory Imaging (FRI). FRI is a quantitative endpoint that identifies mucus plugs in the segmented airways. Mucus volume will be assessed based on movement of mucus plugs and/or clearance from segmental airways. CT scans are obtained to determine FRI and will be obtained and assessed at baseline and after the 4-week treatment period to assess changes in mucus volume within the airways, associated with the Volara treatment. The study will also provide insight into the mechanism of action of the therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of COPD with or without bronchiectasis.
- •Age ≥ 21 years.
- •Naive to Volara therapy.
- •FEV1 < 80% predicted (based on pulmonary function tests within the past 12 months).
- •Daily sputum production over the prior 2 weeks.
- •Signed informed consent.
- •Stable pulmonary disease defined as no change in disease status.
- •Stable medication regimen for 30 days prior to visit 1, defined as no change in prescribed medications and adherence to their prescribed medications for pulmonary disease
排除标准
- •Anticipated requirement for hospitalisation within the next 35 days (± 1 day).
- •History of pneumothorax within the past 6 months prior to visit
- •History of haemoptysis requiring embolization within the past 12 months prior to visit
- •Inability or unwillingness to perform Volara System therapy as directed, without healthcare provider support.
- •Inability or unwillingness to complete study visits and/or provide follow-up data as required per the study protocol.
- •Inability to complete a 6-minute walk.
- •Actively participating in another clinical trial involving an investigational medication or device.
- •Pregnant females as verified by point of care human chorionic gonadotropin test.
- •Current Intrapulmonary Percussive Ventilation and/or oscillation and lung expansion users.
- •Participant requires a prescribed daily regimen for airway clearance with a device or with manual therapy in addition to Volara.
- •Participant requires mechanical ventilation.
- •Participants with artificial airways
结局指标
主要结局
Change in mucus plug volume (mL)
时间窗: 28 Days
Assessed based on movement of mucus plugs and/or clearance from segmental airways
次要结局
未报告次要终点