Real Life Evaluation of the LibAirty Airway Clearance System in Adults With Bronchiectasis (RELACS)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorSynchrony-Medical, Ltd

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Airway clearance system

Treatment groups

200 Participants
are divided into 1 treatment group

Sponsors and collaborators