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

April 15, 2025 updated by: Baxter Healthcare Corporation
The aim of this study is to evaluate the therapeutic effect of therapy with The Volara System on mucus clearance.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Group Assignment
Each participant will be his/her own control comparing their baseline status to an active treatment period.
Device: Volara therapy
Oscillation and Lung Expansion (OLE) therapy, is a respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mucus plug volume (mL)
Time Frame: 28 Days
Assessed based on movement of mucus plugs and/or clearance from segmental airways
28 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baxter Healthcare Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

April 15, 2025

First Submitted That Met QC Criteria

April 15, 2025

First Posted (Actual)

April 22, 2025

Study Record Updates

Last Update Posted (Actual)

April 22, 2025

Last Update Submitted That Met QC Criteria

April 15, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BXU602317
  • CIV-25-04-052074 (Other Identifier: Eudamed)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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