Not Yet RecruitingNot Applicable

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

Belgium10 participantsStarted 2025-05

Plain-language summary

The aim of this study is to evaluate the therapeutic effect of therapy with The Volara System on mucus clearance.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. Anticipated requirement for hospitalisation within the next 35 days (± 1 day).
. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in mucus plug volume (mL)

Timeframe: 28 Days

Trial details

NCT IDNCT06937216

SponsorBaxter Healthcare Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09

Contact for this trial

Danielle Endres, RN

+13157296141 danielle_endres@baxter.com

View on ClinicalTrials.gov More Bronchiectasis Adult trials