Bronchiectasis AdultNCT07135284
Real Life Evaluation of the LibAirty Airway Clearance System in Adults With Bronchiectasis (RELACS)
An observational study of Bronchiectasis Adult, run by Synchrony-Medical, Ltd at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Bronchiectasis Adult
- What is being tested?
- Airway clearance system
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Aug 2025to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Emory University School Of Medicine
Atlanta, Georgia, 30342
Study Coordinator, 404-544-2105, aanwar@emory.edu
Colin Swenson, MD
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Clinical Research Cordinator, 205.638.5134, rseverinsen@uabmc.edu
George Martin Solomon, MD
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Study Coordinator, 843-792-2123, woodenm@musc.edu
Patrick Flume, MD
About this study
Official title: Real Life Evaluation of the LibAirty Airway Clearance System in Adults With Bronchiectasis (RELACS) - A Prospective Study
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?
Read more
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.
Read the detailed description
This prospective, single-arm, open-label study aims to evaluate the real-world use of the LibAirty™ Airway Clearance System for airway clearance in adult patients with bronchiectasis in a home setting. The primary objective is to assess the rate of pulmonary exacerbations during the 12-month study period, compared to the 12 months prior to enrollment, using each participant as their own historical control.
Importantly, this study is observational in nature. Participants are prescribed the LibAirty™ system by their treating physician as part of routine clinical care, independent of study enrollment. The study does not assign participants to receive the device, nor does it provide the device as part of the study. Participants will use the LibAirty™ system in the same manner and frequency as they would outside of the study, based on the physician's clinical judgment and standard treatment protocols.
The study will observe clinical outcomes in participants who are already prescribed the device. Data will be collected prospectively during regularly scheduled clinic visits that occur as part of each participant's standard care. At up to four of these visits, information will be gathered from medical records, and participants will complete validated questionnaires to assess health-related quality of life and user satisfaction with the LibAirty™ system. Adherence to therapy will be assessed using usage logs recorded by the device.
Additional clinical outcomes such as hospitalizations, emergency department visits, use of antibiotics for exacerbations, pulmonary function test results, and healthcare resource utilization related to bronchiectasis will be monitored. No investigational procedures, treatments, or interventions are introduced or modified by the study team.
This study is designed to generate real-world evidence on the effectiveness, adherence, and patient experience associated with the LibAirty™ system when used as part of standard bronchiectasis care in the home setting.
- Conditions
- Bronchiectasis Adult
- Being tested
- Airway clearance system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway clearance systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Adults with bronchiectasis | Adults with bronchiectasis, prescribed with the LibAirty airway clearance system Receives: Device: Airway clearance system |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint for this study is the rate of pulmonary exacerbations (PE).
Measured: 12 months
Secondary outcomes (10)
Rate of respiratory related hospitalizations, including length of stay
Measured: 12 months
Rate of severe PEs (requiring IV antibiotics and/or hospitalization)
Measured: 12 months
Number of respiratory related ED visits
Measured: 12 months
Change from Baseline in PFTs (FEV1)
Measured: 12 months
Change from Baseline in PFTs (FVC)
Measured: 12 months
Change from Baseline in PFTs (FEV1/FVC)
Measured: 12 months
Change from baseline in Quality of Life (QoL-B)
Measured: 12 months
User satisfaction with the LibAirty system
Evaluated using a LibAirty™ system user satisfaction questionnaire
Measured: 12 months
Adherence to therapy
Adherence to therapy will be evaluated using device usage logs
Measured: 12 months
Healthcare resource utilization resulting from respiratory condition
Cost of treatments, hospitalizations and ED visits
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start20 Aug 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiectasis AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Synchrony-Medical, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135284
- Sponsor's protocol ID
- CL-00010
- Status last verified
- Apr 2026
- First submitted
- 26 Jun 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real Life Evaluation of the LibAirty Airway Clearance System in Adults With Bronchiectasis (RELACS) - A Prospective Study
- ClinicalTrials.gov ID
- NCT07135284
- Acronym / sponsor ID
- CL-00010
- Conditions
- Bronchiectasis Adult
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Synchrony-Medical, LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This prospective, single-arm, open-label study aims to evaluate the real-world use of the LibAirty™ Airway Clearance System for airway clearance in adult patients with bronchiectasis in a home setting. The primary objective is to assess the rate of pulmonary exacerbations during the 12-month study period, compared to the 12 months prior to enrollment, using each participant as their own historical control.
Importantly, this study is observational in nature. Participants are prescribed the LibAirty™ system by their treating physician as part of routine clinical care, independent of study enrollment. The study does not assign participants to receive the device, nor does it provide the device as part of the study. Participants will use the LibAirty™ system in the same manner and frequency as they would outside of the study, based on the physician's clinical judgment and standard treatment protocols.
The study will observe clinical outcomes in participants who are already prescribed the device. Data will be collected prospectively during regularly scheduled clinic visits that occur as part of each participant's standard care. At up to four of these visits, information will be gathered from medical records, and participants will complete validated questionnaires to assess health-related quality of life and user satisfaction with the LibAirty™ system. Adherence to therapy will be assessed using usage logs recorded by the device.
Additional clinical outcomes such as hospitalizations, emergency department visits, use of antibiotics for exacerbations, pulmonary function test results, and healthcare resource utilization related to bronchiectasis will be monitored. No investigational procedures, treatments, or interventions are introduced or modified by the study team.
This study is designed to generate real-world evidence on the effectiveness, adherence, and patient experience associated with the LibAirty™ system when used as part of standard bronchiectasis care in the home setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with bronchiectasis | – | Device: Airway clearance systemAdults with bronchiectasis, prescribed with the LibAirty airway clearance system |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- Have a radiological diagnosis of Bronchiectasis based on high resolution chest CT scan
- Have bronchiectasis characterized by either:
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Airway clearance systemThe 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. | Device | Adults with bronchiectasis |
Primary outcome
The primary endpoint for this study is the rate of pulmonary exacerbations (PE).
Time frame: 12 months
10 secondary outcomes
Rate of respiratory related hospitalizations, including length of stay
Time frame: 12 months
Rate of severe PEs (requiring IV antibiotics and/or hospitalization)
Time frame: 12 months
Number of respiratory related ED visits
Time frame: 12 months
Change from Baseline in PFTs (FEV1)
Time frame: 12 months
Change from Baseline in PFTs (FVC)
Time frame: 12 months
Change from Baseline in PFTs (FEV1/FVC)
Time frame: 12 months
Change from baseline in Quality of Life (QoL-B)
Time frame: 12 months
User satisfaction with the LibAirty system
Time frame: 12 months
Adherence to therapy
Time frame: 12 months
Healthcare resource utilization resulting from respiratory condition
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
Related trials for Bronchiectasis Adult
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
RecruitingPhase 3
Compare Oral Itraconazole and Standard Care Versus Standard Care Alone in Patients With Non-cystic Fibrosis Related Bronchiectasis With Chronic Aspergillus Infection in Reducing Bronchiectasis Exacerbations
Bronchiectasis, Bronchiectasis Adult
RecruitingPhase 2
Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NCFB)
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingPhase 1
A Phase 1a/1b Study to Investigate the Safety, Tolerability, Microbiological Response, and Pharmacokinetics of Inhaled Rev-56 in Adult Healthy Volunteers and Adult Non-cystic Fibrosis Bronchiectasis (NCFB) Patients With Chronic P. Aeruginosa
Healthy Participants, Non-cystic Fibrosis Bronchiectasis
RecruitingPhase 4
Azithromycin to Modify Bronchiectasis Exacerbation Risk
Non-cystic Fibrosis Bronchiectasis, Bronchiectasis Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis Adult, run by Synchrony-Medical, Ltd at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint for this study is the rate of pulmonary exacerbations (PE). (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.