Real Life Evaluation of the LibAirty Airway Clearance System in Adults With Bronchiectasis (RELACS) - A Prospective Study
Synchrony-Medical, Ltd
Summary
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.
Description
This prospective, single-arm, open-label study aims to evaluate the real-world use of the LibAirty™ Airway Clearance System for airway clearance in adult patients with bronchiectasis in a home setting. The primary objective is to assess the rate of pulmonary exacerbations during the 12-month study period, compared to the 12 months prior to enrollment, using each participant as their own historical control. Importantly, this study is observational in nature. Participants are prescribed the LibAirty™ system by their treating physician as part of routine clinical care, independent of study enrol…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Have a radiological diagnosis of Bronchiectasis based on high resolution chest CT scan 2. Have bronchiectasis characterized by either: * Daily productive cough (as determined by a treating physician) * OR Available documentation from the last 12 months of 2 or more pulmonary exacerbations requiring antibiotic therapy 3. Be at age ≥ 21 years 4. Prescribed and receives the LibAirty system for home use 5. Be on a standard of care treatment plan that includes at least one physician encounter every 6 months 6. No change in treatment for Bronchiectasis in the 2-month p…
Interventions
- DeviceAirway clearance system
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.
Locations (3)
- University of Alabama at BirminghamBirmingham, Alabama
- Emory University School Of MedicineAtlanta, Georgia
- Medical University of South CarolinaCharleston, South Carolina