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

NCT07135284 | Recruiting FDA Device

• 1 other identifier: CL-00010
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• The primary endpoint for this study is the rate of pulmonary exacerbations (PE).

  12 months

Secondary Outcomes (10)

• Rate of respiratory related hospitalizations, including length of stay

  12 months

• Rate of severe PEs (requiring IV antibiotics and/or hospitalization)

  12 months

• Number of respiratory related ED visits

  12 months

• Change from Baseline in PFTs (FEV1)

  12 months

• Change from Baseline in PFTs (FVC)

  12 months

Other Outcomes (3)

• Time to first PE and median time between PEs

  12 months

• Percent of patients who have not experienced a PE for 6 months and 12 months

  6 months and 12 months

• Number of courses of antibiotics prescribed for pulmonary exacerbations, including duration and route of administration

  12 months

Study Arms (1)

Adults with bronchiectasis

Adults with bronchiectasis, prescribed with the LibAirty airway clearance system

Device: Airway clearance system

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.

Adults with bronchiectasis

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Have a radiological diagnosis of Bronchiectasis based on high resolution chest CT scan
• 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
• Be at age ≥ 21 years
• Prescribed and receives the LibAirty system for home use
• Be on a standard of care treatment plan that includes at least one physician encounter every 6 months
• No change in treatment for Bronchiectasis in the 2-month period prior to enrollment
• Signed informed consent

You may not qualify if:

• 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).

Sponsors & Collaborators

• Synchrony-Medical, Ltd: lead

Study Sites (3)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

Emory University School Of Medicine

Atlanta, Georgia, 30342, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: August 22, 2025
• Study Start: August 20, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (3)