Volara therapy: Oscillation and Lung Expansion (OLE) therapy, is a respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure
Study summary
The aim of this study is to evaluate the therapeutic effect of therapy with The Volara System on mucus clearance.
Eligibility
Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Change in mucus plug volume (mL) — 28 Days Assessed based on movement of mucus plugs and/or clearance from segmental airways
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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