Actively Recruiting
Bronchoscopic Release of Air Trapped in Hyperinflated Emphysematous Lung Study 3 Evaluating Apreo BREATHE Airway Scaffold and Optimal Medical Management
Led by Apreo Health, Inc. · Updated on 2026-04-24
250
Participants Needed
22
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the Apreo BREATHE system as a treatment for adults with COPD and emphysema who experience breathlessness due to trapped air and lung hyperinflation despite receiving optimal medical care. This study involves up to 250 participants at centers in the United States and Europe, with a follow-up period of three years to determine if the device is safe and helpful. Participants will be randomly assigned in a 2:1 ratio to either receive the Apreo BREATHE Airway Scaffold implants along with optimal medical management or to receive only the optimized medical care. The treatment involves a single bronchoscopy procedure during which up to three implants per lung are placed to help open airways. All participants will continue receiving medical treatments such as smoking cessation support, vaccinations, medications, and pulmonary rehabilitation as recommended. There is also a Roll-In phase at each site enrolling a small number of subjects before randomization. Throughout the study, participants will attend follow-up visits at 1, 3, 6, and 12 months, and then at 2 and 3 years after treatment or randomization. These visits include evaluations of lung function, questionnaires about respiratory health, CT scans to assess lung structure, and monitoring for any adverse effects. Participants in the control group may opt to receive the implant treatment after their 12-month visit, with additional follow-up assessments after crossover. The main outcome measured is the improvement in lung function, specifically Forced Expiratory Volume in 1 second (FEV1) at 12 months.
CONDITIONS
Brief Title
Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 40 and 84 years
- Body mass index between 18 and 32
- Completed a documented pulmonary rehabilitation program within 12 months prior to baseline
- Modified Medical Research Council (mMRC) score of 2 or higher
- Ability to walk at least 100 meters in 6 minutes
- At least 25% emphysema destruction score in each lung on baseline HRCT scan
- Presence of homogeneous or heterogeneous emphysema with at least 15% difference between upper and lower lobes in one lung
- Bilateral heterogeneous emphysema with post-bronchodilator residual volume (RV) ≥180% predicted, or one lung with homogeneous emphysema and RV ≥200% predicted
- Post-bronchodilator FEV1/FVC ratio less than 0.70
- Post-bronchodilator FEV1 percent predicted between 15% and 45%
- Post-bronchodilator RV/total lung capacity ratio ≥0.55
- Diffusing capacity of the lung for carbon monoxide (DLCO) ≥20%
- Receiving optimal medical management tailored to patient needs for 2 months prior to enrollment
- No active smoking for at least 4 months and agreement to smoking cessation during the study
- Received recommended vaccinations against respiratory infections or have documented intolerance
- Able to undergo bronchoscopy under general anesthesia and adhere to study follow-up
- Provided written informed consent
You will not qualify if you...
- Known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection, fungus, tuberculosis)
- Steroid-dependent condition requiring 10 mg or more oral corticosteroid per day
- Bilateral lobar emphysema destruction scores over 70% on CT scan
- Arterial or capillary blood gas abnormalities: PaCO2 > 50 mmHg or PaO2 ≤ 45 mmHg on room air
- Two or more hospitalizations for acute COPD exacerbations or three or more moderate exacerbations or respiratory infections in past year
- Previous lung volume reduction surgery, lobectomy, pneumonectomy, segmentectomy, bullectomy, lung transplant, vapor, glue, or other pulmonary device implant (unless removed ≥3 months prior)
- Known or suspected pulmonary arterial hypertension
- Presence of a giant bulla occupying 30% or more of one lung side
- Active adult asthma or chronic bronchitis as primary diagnosis causing significant symptoms
- Suspicious radiological abnormalities that may need intervention
- Clinically significant bronchiectasis with heavy mucus production affecting COPD symptoms
- Unresolved lung cancer
- Serious medical conditions that may affect safety or study results (e.g., heart failure, recent heart attack, renal failure, liver disease, stroke, uncontrolled diabetes or hypertension, autoimmune disease requiring immunosuppression, chemotherapy)
- On anticoagulant or antiplatelet therapy that cannot be safely stopped for bronchoscopy
- Mechanical ventilator dependency
- Pregnant, breastfeeding, or planning pregnancy during the study
- Known allergy to nickel-titanium alloy or its metals
- Significant immunocompromise such as organ transplant, congenital immune deficiencies, AIDS, or severe rheumatoid arthritis
- Allergy to medications needed for bronchoscopy under general anesthesia
- Currently enrolled in another investigational study affecting COPD or symptoms
- Severe COVID-19 respiratory infection requiring ICU support within 2 years prior to consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure day
Participants in the treatment group undergo a single bronchoscopy procedure for bilateral placement of up to 3 airway implants per lung in appropriately selected airways. All participants receive optimal medical management tailored to their needs according to standard care.
1 visit (in-person)
Duration - Up to 3 years
Participants receive optimal medical management tailored to their needs, including smoking cessation, vaccinations, bronchodilator therapy, corticosteroids if appropriate, and participation in exercise or pulmonary rehabilitation programs.
Follow-up visits at Months 1, 3, 6, 12, and Years 2 and 3
Duration - Up to 15 months after baseline for crossover, with follow-ups at 7 and 30 days, and 6 months post-procedure
Control group participants who elect to cross over receive the airway implant procedure and have additional follow-up visits to monitor their progress post-procedure.
3 visits (in-person) for crossover follow-up
Trial Site Locations
Total: 22 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Banner Health
Gilbert, Arizona, United States, 85234
Actively Recruiting
3
University of California at Davis
Sacramento, California, United States, 95817
Actively Recruiting
4
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
5
Orlando Health
Orlando, Florida, United States, 32806
Actively Recruiting
6
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
7
OSF St Francis Medical Center
Peoria, Illinois, United States, 61637
Actively Recruiting
8
University of Kansas Medical Center Research Institute
Kansas City, Kansas, United States, 66160
Actively Recruiting
9
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
10
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
11
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44103
Actively Recruiting
12
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
13
Clinical Research Associates of Central Pennsylvania
DuBois, Pennsylvania, United States, 15801
Actively Recruiting
14
Temple University
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
15
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
16
Houston Methodist/Primary Critical Care
Houston, Texas, United States, 77030
Actively Recruiting
17
Inova Health Care Services
Falls Church, Virginia, United States, 22042
Actively Recruiting
18
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
19
Karl Landsteiner Institute - Klink Floridsdorf
Vienna, Austria, A-1210
Actively Recruiting
20
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
Actively Recruiting
21
St. Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
Actively Recruiting
22
Royal Brompton Hospital
London, United Kingdom, SW36JY
Actively Recruiting
Research Team
C
Cindy Holtz
N
Nina Mohmood
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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