Recruiting

LibAirty™ System

Sponsor:

Synchrony-Medical, Ltd

Code:

NCT07135284

Conditions

Bronchiectasis Adult

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Airway clearance system

Study Details

Brief 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.

Conditions

Bronchiectasis Adult

Study ID

NCT07135284

Start date

Aug 20, 2025

Status verified date

Apr, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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 period prior to enrollment
7. Signed informed consent

Exclusion Criteria:

1. Inability to independently perform therapy with the LibAirty system as directed
2. 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.
3. Pregnancy or planned pregnancy during the expected duration of the trial (12 months).

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Adults with bronchiectasis

Adults with bronchiectasis, prescribed with the LibAirty airway clearance system

Interventions

Airway 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.

Primary outcome measure

  • The primary endpoint for this study is the rate of pulmonary exacerbations (PE). [ Time Frame: 12 months ]

Central Contacts and Locations

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Clinical Research Cordinator

205.638.5134rseverinsen@uabmc.edu

Principal Investigator:

George Martin Solomon, MD

Emory University School Of Medicine

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Study Coordinator

404-544-2105aanwar@emory.edu

Principal Investigator:

Colin Swenson, MD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Study Coordinator

843-792-2123woodenm@musc.edu

Principal Investigator:

Patrick Flume, MD

More Information

Sponsor

Synchrony-Medical, Ltd

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Synchrony-Medical, Ltd on 2026-04-13.