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 — DEVICE
    The 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 bronchiectasis
    Adults 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)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Clinical Research Cordinator
205.638.5134
George Martin Solomon, MD (PRINCIPAL_INVESTIGATOR)
Emory University School Of MedicineAtlantaGeorgia30342
Study Coordinator
404-544-2105
Colin Swenson, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29425
Study Coordinator
843-792-2123
Patrick Flume, MD (PRINCIPAL_INVESTIGATOR)

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