Evaluation of the Effectiveness of The Volara System Determined by Sputum Movement and Production

Korábbi kezelés

• History of pneumothorax within the past 6 months prior to visit 1.
• History of haemoptysis requiring embolization within the past 12 months prior to visit 1.
• Inability or unwillingness to perform Volara System therapy as directed, without healthcare provider support.
• Actively participating in another clinical trial involving an investigational medication or device.

Laborértékek

• Participant requires a prescribed daily regimen for airway clearance with a device or with manual therapy in addition to Volara.

Egyéb

• Anticipated requirement for hospitalisation within the next 35 days (± 1 day).
• 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.
• 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 mechanical ventilation.
• Participants with artificial airways

• 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