Actively Recruiting
Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3
Led by Apreo Health, Inc. · Updated on 2026-04-24
250
Participants Needed
22
Research Sites
232 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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?
CONDITIONS
Official 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 (BMI) between 18 and 32 inclusive
- Completed a documented pulmonary rehabilitation program within 12 months prior to baseline
- Modified Medical Research Council (mMRC) score of 2 or higher
- Able to walk at least 100 meters in 6 minutes
- At least 25% emphysema destruction score in each lung on baseline HRCT scan
- 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 homogeneous emphysema in one lung with RV ≥ 200% predicted
- Post-bronchodilator FEV1/FVC ratio less than 0.70
- Post-bronchodilator FEV1 percent predicted between 15% and 45%
- Post-bronchodilator RV/TLC ratio of 0.55 or higher
- Diffusing capacity of the lungs for carbon monoxide (DLCO) 20% or higher
- Receiving optimal medical management tailored to needs for at least 2 months before enrollment
- No active smoking within the last 4 months and agreement to smoking cessation during the study
- Received preventive vaccinations or documented intolerance against respiratory infections including pneumococcus, influenza, RSV (if over 60 years), and Covid-19
- Able to undergo bronchoscopy under general anesthesia and adhere to follow-up schedule
- Provided written informed consent
You will not qualify if you...
- Known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare, fungus, tuberculosis)
- Steroid-dependent condition requiring ≥10 mg oral corticosteroid daily
- 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 COPD exacerbations or three or more moderate exacerbations/respiratory infections in the past year
- Previous lung volume reduction surgery, lobectomy, pneumonectomy, or other pulmonary device implants unless removed at least 3 months before consent
- Known or suspected pulmonary arterial hypertension
- Presence of a giant bulla ≥ 30% of hemithorax
- Active adult asthma or chronic bronchitis as primary diagnosis
- Suspicious radiological abnormalities on HRCT requiring intervention
- Clinically significant bronchiectasis affecting COPD symptoms
- Unresolved lung cancer
- Serious medical conditions compromising safety or study interpretation (e.g., heart failure, recent myocardial infarction, renal failure, liver disease, stroke, uncontrolled diabetes or hypertension, autoimmune diseases requiring immunosuppressants)
- On anticoagulant or antiplatelet therapy preventing bronchoscopy
- Invasive mechanical ventilator dependency
- Pregnant, lactating, or planning pregnancy during study
- Known allergy to nickel-titanium or its metals
- Significantly immunocompromised (e.g., organ transplant, AIDS, severe rheumatoid arthritis)
- Allergy to medications needed for bronchoscopy under general anesthesia
- Participation in another investigational study affecting COPD symptoms
- Severe COVID-19 infection requiring ICU support with ventilation within 2 years before consent
AI-Screening
AI-Powered Screening
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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
CONTACT
N
Nina Mohmood
CONTACT
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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