Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3
NCT ID: NCT06891755
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
250 participants
INTERVENTIONAL
2025-07-15
2029-12-31
Brief Summary
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Detailed Description
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Each site will participate in a Roll-In phase prior to participation in the randomized phase of the study. Each site will enroll up to 2 subjects in this phase. Up to 50 subjects may be enrolled into the Roll-In cohort.
Up to 200 subjects with bilateral emphysema will be randomized at up to 25 centers in the United States centers and Europe.
In the Randomized cohort, subjects will be randomized to either a Treatment or Control group in a 2:1 ratio.
* Optimal Medical Management: All subjects (Roll-in and Randomized) will receive optimal medical management tailored to patient needs and per standard of care and as outlined in the 2024 GOLD report. This may include smoking cessation, vaccination, long-acting bronchodilator therapy, corticosteroids (when appropriate), and participation in or maintenance of an exercise program or pulmonary rehabilitation program.
* Treatment group: 133 subjects will receive optimal medical management and Apreo Implant placements. Treatment group subjects will undergo a single bronchoscopy with bilateral placement of up to 3 implants per lung in appropriately selected target airways. Appropriate target segments shall be based on segmental and lobar information (i.e. airway dimensional, emphysematous destruction, volumetric information, hetero/homogeneity) provided in the Quantitative CT (QCT) report for each patient.
* Control group: 67 subjects will receive optimal medical management. Control group subjects will be allowed the opportunity to cross over and receive the BREATHE treatment after their Month 12 visit and within 15 months from their baseline visit.
Subjects will undergo follow-up assessments at Months 1, 3, 6 and 12, and Years 2 and 3 post-procedure (treatment group) or post-randomization (control group). These visits will involve adverse event assessment, questionnaires, pulmonary function testing, and inspiratory/ expiratory CT scans.
Control group subjects electing crossover will then have additional follow-ups at 7- and 30-days post procedure, and 6 months post procedure. Control group subjects not electing crossover will be exited from the study after Month 12.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Apreo implants + Optimal Medical Management
Treatment group participants will receive optimal medical management and will undergo a single bronchoscopy with bilateral placement of up to 3 implants per lung in appropriately selected targeted airways.
Apreo BREATHE Airway Scaffold
The experimental treatment involves placement of up to 6 Apreo BREATHE Airway Scaffolds (up to 3 per lung), in a single procedure using bronchoscopy and fluoroscopy. Treatment group subjects will also receive optimal medical management (OMM).
Optimal Medical Management
Control group participants will receive optimal medical management tailored to patient needs and per standard of care and as outlined in the 2024 GOLD report. This may include smoking cessation, vaccination, long-acting bronchodilator therapy, corticosteroids (when appropriate), and participation in or maintenance of an exercise program or pulmonary rehabilitation program.
Optimal Medical Management (OMM)
Subjects will receive optimal medical management tailored to patient needs and per standard of care and as outlined in the 2024 GOLD report. This may include smoking cessation, vaccination, long-acting bronchodilator therapy, corticosteroids (when appropriate), and participation in or maintenance of an exercise program or pulmonary rehabilitation program.
Interventions
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Apreo BREATHE Airway Scaffold
The experimental treatment involves placement of up to 6 Apreo BREATHE Airway Scaffolds (up to 3 per lung), in a single procedure using bronchoscopy and fluoroscopy. Treatment group subjects will also receive optimal medical management (OMM).
Optimal Medical Management (OMM)
Subjects will receive optimal medical management tailored to patient needs and per standard of care and as outlined in the 2024 GOLD report. This may include smoking cessation, vaccination, long-acting bronchodilator therapy, corticosteroids (when appropriate), and participation in or maintenance of an exercise program or pulmonary rehabilitation program.
Eligibility Criteria
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Inclusion Criteria
2. Subject has body mass index (BMI) of between 18 and 32, inclusive.
3. Subject has completed a documented pulmonary rehabilitation program within 12 months prior to Baseline.
4. Subject has mMRC score ≥ 2.
5. Subject can walk ≥100 meters in 6 minutes.
6. Subject has ≥25% emphysema destruction score in each lung as quantified on baseline HRCT scan (low attenuation area less than -950HU) as determined by the CT core lab.
7. Subject has homogeneous or heterogeneous emphysema, and at least one lung has a 15% difference between upper and lower lobes in emphysema destruction score (-910HU) as determined by the CT core lab.
8. Subject has bilateral heterogenous emphysema and pre-procedure post-bronchodilator RV ≥ 180% predicted, or one lung with homogenous emphysema and pre-procedure postbronchodilator RV ≥ 200% predicted.
9. Subject has pre-procedure post-bronchodilator FEV1/ FVC \< 0.70.
10. Subject has a pre-procedure post-bronchodilator FEV1 percent predicted of ≥15% and ≤45%.
11. Subject has pre-procedure post-bronchodilator RV/TLC ≥ 0.55.
12. Subject has pre-procedure DLCO ≥ 20%.
13. Subject has been receiving optimal medical management tailored to subject needs for 2 months prior to enrollment.
14. Subject has not actively smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.) within the last 4 months, and agrees to smoking cessation during the study.
15. Subject has received preventative vaccinations (or documented clinical intolerance) against potential respiratory infections, including pneumococcus, influenza, RSV (subjects \>60 yrs. old) and Covid-19, consistent with local recommendations or policy.
16. In the opinion of the Primary investigator, subject can undergo bronchoscopy under general anesthesia and is able to adhere to the study follow-up schedule.
17. Subject has provided written informed consent.
Exclusion Criteria
2. Subject has a steroid-dependent condition requiring (e.g. ≥10 mg oral corticosteroid per day).
3. Subject has bilateral lobar emphysematous destruction scores of \>70% percent of voxels with \<-950 Hounsfield units on thin slice inspiratory CT, as determined by the CT core lab.
4. Subject has arterial or capillary blood on room air: PaCO2 \> 50 mmHg (8 kPa) or PaO2 ≤ 45 mmHg (6 kPa).
5. Subject has had ≥2 hospitalization for acute exacerbations of COPD or ≥3 moderate exacerbations/respiratory infections in the year prior to enrollment.
6. Subject has had previous lung volume reduction surgery, lobectomy, pneumonectomy, segmentectomy, bullectomy, lung transplantation, vapor, glue, or other pulmonary device implant (unless the device has been removed at least 3 months prior to consent).
7. Subject has known or suspected history of pulmonary arterial hypertension (e.g. PASP \> 50mmHg on echocardiogram in absence of confirmation on a right heart catheterization or mPAP \> 25mmHg on a right heart catheterization).
8. Subject has presence of a giant bulla (≥ 30% of hemithorax).
9. Subject has significant symptom burden due to currently active adult asthma based on GINA criteria and/or chronic bronchitis as their primary diagnosis.
10. Subject has presence of suspicious radiological abnormalities on HRCT scan such as pulmonary nodule/infiltrate that in judgement of the PI, may require intervention during course of the study.
11. Subject has clinically significant bronchiectasis (\>4 TBS / 45mL mucus production/day, per subject estimate) influencing subject's COPD symptoms.
12. Subject has unresolved lung cancer.
13. Subject has a serious medical condition that, in the Primary investigator's opinion, could compromise patient safety or confound the interpretation of the patient's response to therapy (e.g., congestive heart failure, cardiomyopathy (documented LVEF ≤40%), or myocardial infarction in the past year, renal failure, liver disease cerebrovascular accident within the past 6 months, uncontrolled diabetes (HbA1c \>8%), uncontrolled hypertension (diastolic BP \>110 mmHg or systolic \>200 mmHg) or autoimmune disease requiring treatment with immunosuppressant medications or a disease requiring chemotherapy.
14. Subject is on anticoagulant or antiplatelet therapy for cardiovascular indications and, at the discretion of the Primary investigator, is unable to have anticoagulants withheld for a bronchoscopy procedure per institution's standard of care.
15. Subject has invasive mechanical ventilator dependency.
16. Subject is pregnant, lactating, or of childbearing potential and plans to become pregnant during study duration.
17. Subject has known hypersensitivity to Nitinol (nickel-titanium alloy) or its constituent metals (nickel or titanium).
18. Subject is significantly immunocompromised, such as organ transplant recipients, those with congenital immune deficiencies, AIDS, or severe rheumatoid arthritis.
19. Subject has sensitivity or allergy to medications necessary for bronchoscopy under general anesthesia.
20. Subject is currently participating in another study involving an investigational product that could confound the study results or affect the subject's COPD symptoms.
21. Subject has within the 2 years prior to consent, had a severe respiratory infection with SARS-CoV-2 (COVID-19) that required ICU support with non-invasive and/or invasive mechanical ventilation.
40 Years
84 Years
ALL
No
Sponsors
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Apreo Health, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Gerard Criner, MD
Role: PRINCIPAL_INVESTIGATOR
Temple University
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Banner Health
Gilbert, Arizona, United States
University of California at Davis
Sacramento, California, United States
Mayo Clinic
Jacksonville, Florida, United States
Orlando Health
Orlando, Florida, United States
University of Chicago
Chicago, Illinois, United States
OSF St Francis Medical Center
Peoria, Illinois, United States
University of Kansas Medical Center Research Institute
Kansas City, Kansas, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Clinical Research Associates of Central Pennsylvania
DuBois, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Houston Methodist/Primary Critical Care
Houston, Texas, United States
Inova Health Care Services
Falls Church, Virginia, United States
University Medical Center Groningen
Groningen, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Elizabeth Plan
Role: primary
Robert Flynn
Role: primary
Daniel Tompkins
Role: primary
John Hatzimouratides
Role: primary
Roasa Boscan
Role: primary
Donya Shahnavas
Role: backup
Vanita Patel
Role: primary
Jessica Tuck
Role: backup
Kimberly Hartwig
Role: primary
Jamie Quigley
Role: primary
Paula Aranguren
Role: primary
Christine Conley
Role: backup
Crystal Cutlip
Role: primary
Yvonne Meli
Role: primary
Amy Miller
Role: primary
Hailey Adams
Role: primary
Gerard Criner, MD
Role: primary
Helga Criner
Role: backup
Paula Consolaro
Role: primary
Brooke Shope
Role: primary
Lori Schlegel
Role: primary
Karin Klooster
Role: primary
Other Identifiers
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CIP-0028
Identifier Type: -
Identifier Source: org_study_id