Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3
Start Date
7/15/2025
Completion Date
12/31/2029
Summary
The objective of this study is to assess the safety and efficacy of Apreo BREATHE system when used to support native airways and release trapped air in the treatment of adult COPD patients with emphysema suffering from dyspnea due to hyperinflation despite optimal medical treatment. The Apreo BREATHE Airway Scaffold is a permanent implant designed to tent open native airways. The study will include up to 250 participants at up to 25 study centers located in the United States and Europe. Study subjects will be followed for 3 years. The main questions it aims to answer are: Is it safe? Does it work?
Detailed Description
Prospective, randomized, two arm, parallel group, concurrently controlled, open-label, multi-center clinical trial following up to 250 participants to 3 years. 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.
Eligibility Criteria
Age Range: 40 years to 84 years
Interventions
Apreo BREATHE Airway Scaffold
Optimal Medical Management (OMM)
Conditions
Locations
University of Alabama at Birmingham
Birmingham, Alabama 35233
United States
Banner Health
Gilbert, Arizona 85234
United States
University of California at Davis
Sacramento, California 95817
United States
Mayo Clinic
Jacksonville, Florida 32224
United States
Orlando Health
Orlando, Florida 32806
United States
University of Chicago
Chicago, Illinois 60637
United States
OSF St Francis Medical Center
Peoria, Illinois 61637
United States
University of Kansas Medical Center Research Institute
Kansas City, Kansas 66160
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
University of Michigan
Ann Arbor, Michigan 48109
United States
Cleveland Clinic Foundation
Cleveland, Ohio 44103
United States
The Ohio State University
Columbus, Ohio 43210
United States
Clinical Research Associates of Central Pennsylvania
DuBois, Pennsylvania 15801
United States
Temple University
Philadelphia, Pennsylvania 19140
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
United States
Houston Methodist/Primary Critical Care
Houston, Texas 77030
United States
Inova Health Care Services
Falls Church, Virginia 22042
United States
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Karl Landsteiner Institute - Klink Floridsdorf
Vienna, A-1210
Austria
University Medical Center Groningen
Groningen, 9713 GZ
Netherlands
St. Bartholomew's Hospital
London, EC1A 7BE
United Kingdom
Royal Brompton Hospital
London, SW36JY
United Kingdom