Bronchiectasis Clinical Trials

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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Georgia
Emory University School Of Medicine
RECRUITING
Atlanta
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Time Frame
Start Date: 2025-08-20
Estimated Completion Date: 2027-02
Participants
Target number of participants: 200
Treatments
Adults with bronchiectasis
Adults with bronchiectasis, prescribed with the LibAirty airway clearance system
Related Therapeutic Areas
Sponsors
Leads: Synchrony-Medical, Ltd

This content was sourced from clinicaltrials.gov