Home use of the LibAirty airway clearance system for adults with bronchiectasis
Real Life Evaluation of the LibAirty Airway Clearance System in Adults With Bronchiectasis (RELACS) - A Prospective Study
This project will see if using the LibAirty airway clearance system at home reduces pulmonary exacerbations and improves symptoms for adults with bronchiectasis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Synchrony-Medical, Ltd Industry-sponsored |
| Locations | 3 sites (Birmingham, Alabama and 2 other locations) |
| Trial ID | NCT07135284 on ClinicalTrials.gov |
What this trial studies
This prospective, single-arm, open-label observational study follows adults with CT-confirmed bronchiectasis who are already prescribed the LibAirty system for home use. Participants will be followed for 12 months while they continue their usual care, with outcomes compared to each participant's prior 12 months as a historical control. Up to four routine clinic visits will collect medical record data, validated symptom and quality-of-life questionnaires, and device usage logs to measure adherence. The study does not provide the device and does not change prescribing or standard clinical care.
Who should consider this trial
Good fit: Adults aged 21 or older with CT-confirmed bronchiectasis who are prescribed the LibAirty system, have daily productive cough or at least two exacerbations in the past year, and can perform the therapy independently are ideal candidates.
Not a fit: Patients who cannot independently perform the therapy, are pregnant or planning pregnancy during the study, have had recent treatment changes for bronchiectasis, or are not prescribed the LibAirty system are unlikely to benefit from enrolling.
Why it matters
Potential benefit: If successful, using LibAirty at home could reduce the number of flare-ups, decrease healthcare visits or hospitalizations, and improve daily symptoms and quality of life.
How similar studies have performed: Airway clearance techniques and similar oscillatory devices have shown benefit in some bronchiectasis studies, but real-world data specific to the LibAirty system remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Birmingham, Alabama and 2 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- Emory University School Of Medicine — Atlanta, Georgia, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.