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.
Have a radiological diagnosis of Bronchiectasis based on high resolution chest CT scan
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
Be at age ≥ 21 years
Inability to independently perform therapy with the LibAirty system as directed
Any other condition that, in the opinion of the PI, could jeopardize the safety of the subject or impact the validity of the study results.
Pregnancy or planned pregnancy during the expected duration of the trial (12 months).
Adults with bronchiectasis who have been prescribed the LibAirty airway clearance system as part of their standard care. Participants will be identified and recruited from outpatient pulmonary or respiratory clinics affiliated with participating study sites.
Cohort
Prospective
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.
The primary endpoint for this study is the rate of pulmonary exacerbations (PE).
Rate of respiratory related hospitalizations, including length of stay
Rate of severe PEs (requiring IV antibiotics and/or hospitalization)
Number of respiratory related ED visits
Change from Baseline in PFTs (FEV1)
Time to first PE and median time between PEs
Percent of patients who have not experienced a PE for 6 months and 12 months
Number of courses of antibiotics prescribed for pulmonary exacerbations, including duration and route of administration
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