Real Life Evaluation of the LibAirty Airway Clearance System in Adults With Bronchiectasis (RELACS)
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Synchrony-Medical, Ltd
- Study ID
- NCT07135284
- Status
- Recruiting
Conditions
- Bronchiectasis Adult
Eligibility Criteria
- Sex
- ALL
- Age
- 21 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Airway clearance system — DEVICEThe device is prescribed as part of each participant's regular medical care, independently of the study. The study does not assign the device or alter standard treatment. Participants are observed while using the device as part of their usual care.
Study Details
The purpose of this study is to collect data to assess the use of the LibAirty™ System for improving bronchiectasis symptoms and healthcare resource utilization when it is used at home. The main question this study is trying to answer is: How often do adults with bronchiectasis experience pulmonary exacerbations (flare-ups of their lung condition) while using the LibAirty™ airway clearance system at home? Participants will use the LibAirty™ airway clearance system at home as prescribed by their doctor - the device is not being provided as part of the study. The study will last for 12 months from the time participants begin using LibAirty. During the study period, participants will continue with their usual clinic visits. At some of these regular visits (up to 4 times over the year), participants will be asked to complete short questionnaires about their bronchiectasis symptoms and their experience using LibAirty. At these same visits, the study team will also review participants' medical records and collect information related to their bronchiectasis condition, such as test results, medications, and any hospital or emergency room visits.
Key Dates
- Start date
- Aug 20, 2025
- Status verified
- Apr 2026
- Primary completion
- Feb 28, 2027
- Completion
- Feb 28, 2027
Study Design
- Enrollment
- 200 participants (estimated)
Arms
- Arm: Adults with bronchiectasisAdults with bronchiectasis, prescribed with the LibAirty airway clearance system
Primary Outcome Measure
The primary endpoint for this study is the rate of pulmonary exacerbations (PE). [ Time Frame: 12 months ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | George Martin Solomon, MD (PRINCIPAL_INVESTIGATOR) |
| Emory University School Of Medicine | Atlanta | Georgia | 30342 | Colin Swenson, MD (PRINCIPAL_INVESTIGATOR) |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | Patrick Flume, MD (PRINCIPAL_INVESTIGATOR) |