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

Launched by BAXTER HEALTHCARE CORPORATION · Apr 15, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to explore how well The Volara System helps patients with bronchiectasis or chronic obstructive pulmonary disease (COPD) clear mucus from their lungs. The goal is to see if using this device can improve the movement and production of sputum, which is the mucus that can build up and cause breathing difficulties.

To participate in this study, you must be at least 21 years old and have a confirmed diagnosis of COPD, with or without bronchiectasis. You should also produce sputum daily and have stable lung disease without recent changes in your health. If you decide to join, you will be expected to use The Volara System as directed and attend study visits to provide feedback on your experience. This trial is not yet recruiting participants, so there will be more information available soon for those interested in taking part.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Documented diagnosis of COPD with or without bronchiectasis.
• • 2. Age ≥ 21 years.
• • 3. Naive to Volara therapy.
• • 4. FEV1 \< 80% predicted (based on pulmonary function tests within the past 12 months).
• • 5. Daily sputum production over the prior 2 weeks.
• • 6. Signed informed consent.
• • 7. Stable pulmonary disease defined as no change in disease status.
• • 8. 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
• Exclusion Criteria:
• • 1. Anticipated requirement for hospitalisation within the next 35 days (± 1 day).
• • 2. History of pneumothorax within the past 6 months prior to visit 1.
• • 3. History of haemoptysis requiring embolization within the past 12 months prior to visit 1.
• • 4. Inability or unwillingness to perform Volara System therapy as directed, without healthcare provider support.
• • 5. Inability or unwillingness to complete study visits and/or provide follow-up data as required per the study protocol.
• • 6. Inability to complete a 6-minute walk.
• • 7. Actively participating in another clinical trial involving an investigational medication or device.
• • 8. Pregnant females as verified by point of care human chorionic gonadotropin test.
• • 9. Current Intrapulmonary Percussive Ventilation and/or oscillation and lung expansion users.
• • 10. Participant requires a prescribed daily regimen for airway clearance with a device or with manual therapy in addition to Volara.
• • 11. Participant requires mechanical ventilation.
• • 12. Participants with artificial airways