COPDBREATHE-3NCT06891755
Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3
A study testing Apreo BREATHE Airway Scaffold and Optimal Medical Management (OMM) in people with COPD and Emphysema, run by Apreo Health, Inc. at 23 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 84 years
- What is being tested?
- Apreo BREATHE Airway Scaffold and Optimal Medical Management (OMM)
- Type of treatment
- Vaccines, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 23 sitesin 5 countries
- Study dates
- 15 Jul 2025to 31 Dec 2029
- Phase
- Interventional
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 40 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is at least 40, but not older than 84, years of age.
- Subject has body mass index (BMI) of between 18 and 32, inclusive.
- Subject has completed a documented pulmonary rehabilitation program within 12 months prior to Baseline.
- Subject has mMRC score ≥ 2.
- Subject can walk ≥100 meters in 6 minutes.
- 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.
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- 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.
- 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.
- Subject has pre-procedure post-bronchodilator FEV1/ FVC < 0.70.
- Subject has a pre-procedure post-bronchodilator FEV1 percent predicted of ≥15% and ≤45%.
- Subject has pre-procedure post-bronchodilator RV/TLC ≥ 0.55.
- Subject has pre-procedure DLCO ≥ 20%.
- Subject has been receiving optimal medical management tailored to subject needs for 2 months prior to enrollment.
- 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.
- 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.
- 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.
- Subject has provided written informed consent.
Who cannot join
- Subject has known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis).
- Subject has a steroid-dependent condition requiring (e.g. ≥10 mg oral corticosteroid per day).
- 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.
- Subject has arterial or capillary blood on room air: PaCO2 > 50 mmHg (8 kPa) or PaO2 ≤ 45 mmHg (6 kPa).
- Subject has had ≥2 hospitalization for acute exacerbations of COPD or ≥3 moderate exacerbations/respiratory infections in the year prior to enrollment.
- 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).
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- 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).
- Subject has presence of a giant bulla (≥ 30% of hemithorax).
- Subject has significant symptom burden due to currently active adult asthma based on GINA criteria and/or chronic bronchitis as their primary diagnosis.
- 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.
- Subject has clinically significant bronchiectasis (>4 TBS / 45mL mucus production/day, per subject estimate) influencing subject's COPD symptoms.
- Subject has unresolved lung cancer.
- 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.
- 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.
- Subject has invasive mechanical ventilator dependency.
- Subject is pregnant, lactating, or of childbearing potential and plans to become pregnant during study duration.
- Subject has known hypersensitivity to Nitinol (nickel-titanium alloy) or its constituent metals (nickel or titanium).
- Subject is significantly immunocompromised, such as organ transplant recipients, those with congenital immune deficiencies, AIDS, or severe rheumatoid arthritis.
- Subject has sensitivity or allergy to medications necessary for bronchoscopy under general anesthesia.
- Subject is currently participating in another study involving an investigational product that could confound the study results or affect the subject's COPD symptoms.
- 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.
Trial locations and contacts
23 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
Nina Mohmood contact
23 sites in 5 countries
United States18 sites, 18 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Kelly Rysso, kahernan@med.umich.edu
Melian Han, MD
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Abigail West, 205-975-0950, amwest@uabmc.edu
Surya Bhatt, MD
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Christine Conley, 617-632-8252, cconley@bidmc.harvard.edu
Adnan Majid, MD
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Jessica Tuck, jessica.tuck@bsd.uchicago.edu
Kyle Hogarth, MD
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44103
Yvonne Meli, 216-445-4215, meliy@ccf.org
Joseph Cicenia, MD
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Amy Miller, 614-366-7935, amy.miller2@osumc.edu
Christian Ghattas, MD
- Recruiting
Clinical Research Associates of Central Pennsylvania
DuBois, Pennsylvania, 15801
Rebecca Taylor, 824-553-8263, rebecca@clinicalresearchassoc.com
Sandeep Bansal, MD
- Recruiting
Inova Health Care Services
Falls Church, Virginia, 22042
Alma Khan, 703-776-5912, alma.khan2@inova.org
Amit "Bobby" Mahajan, MD
- Recruiting
Banner Health
Gilbert, Arizona, 85234
Bethany Kerr, 480-256-5464, Bethany.Kerr2@bannerhealth.com
Robert Flynn, 480-412-6859, Robert.Flynn@bannerhealth.com
- Recruiting
Houston Methodist/Primary Critical Care
Houston, Texas, 77030
Manikantha Bolloju, 346-238-4511, mbolloju@houstonmethodist.org
Lisa Kopas, MD
- Recruiting
Mayo Clinic
Jascksonville, Florida, 32224
John Hatzimouratides, 904-953-8995, Hatzimouratidesjr.John@mayo.edu
Jose Soto-Soto, MD
- Recruiting
University of Kansas Medical Center Research Institute
Kansas City, Kansas, 66160
Jamie Quigley, 913-574-3036, jtroxel@kumc.edu
Maykol Postigo-Jasahui, MD
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Alexandria Cook, 414-955-6839, alcook@mcw.edu
Jonathan Kurman, MD
- Recruiting
Orlando Health
Orlando, Florida, 32806
Donya Shahnavas, donya.shahnavaz@orlandohealth.com
Mark Vollenweider, MD
- Recruiting
OSF St Francis Medical Center
Peoria, Illinois, 61637
Kimberly Hartwig, 309-655-4229, Kimberly.Hartwig@osfhealthcare.org
Peyton Hopkins, Peyton.R.Hopkins@osfhealthcare.org
- Recruiting
Temple University
Philadelphia, Pennsylvania, 19140
Gerard Criner, MD, 215-707-8113, gerard.criner@tuhs.temple.edu
Helga Criner, 215-707-1359, Lii-Yoong.Criner@tuhs.temple.edu
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Paula Consolaro, 412-605-1904, consolaropj@upmc.edu
Frank Sciurba, MD
- Recruiting
University of California at Davis
Sacramento, California, 95817
Daniel Tompkins, 916-734-3845, dgtompkins@health.ucdavis.edu
Karla Ramirez, karamirez@health.ucdavis.edu
United Kingdom2 sites, 2 recruiting
- Recruiting
St. Bartholomew's Hospital
London, EC1A 7BE
Samy Winnie, +442037658535, w.samy@nhs.net
Kelvin Lau, MD
- Recruiting
Royal Brompton Hospital
London, SW36JY
Jon Panaguiton, MD, jon.panaguiton3@nhs.net
Pallav Shah, Professor
Austria1 site, 1 recruiting
- Recruiting
Karl Landsteiner Institute - Klink Floridsdorf
Vienna, A-1210
Raphaela Wahrmann, raphaela.wahrmann@extern.gesundheitsverbund.at
Arschang Valipour, Professor
Germany1 site, 1 recruiting
- Recruiting
Thoraxklinik Heidelberg
Heidelberg, 69126
Brigitte Rump, +49 6221 396-1211, Brigitte.Rump@med.uni-heidelberg.de
Eva Gaitzsch, MD, eva.gaitzsch@med.uni-heidelberg.de
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9713 GZ
Karin Klooster, +31 (50) 361 3279, k.klooster@umcg.nl
Dirk-Jan Slebos, Professor
About this study
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?
Read the 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.
- Being tested
- Apreo BREATHE Airway Scaffold, Optimal Medical Management (OMM)
- Keywords
- Apreo, COPD, Emphysema, BREATHE System, Hyperinflation, Air-trapping, Apreo BREATHE Airway Scaffold, BREATHE Implant, Airway Scaffold, Apreo Health
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apreo BREATHE Airway ScaffoldDevice
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)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Apreo implants + Optimal Medical Management | Experimental | 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. Receives: Device: Apreo BREATHE Airway Scaffold |
| Optimal Medical Management | Other | 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. Receives: Other: Optimal Medical Management (OMM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in 1 second (FEV1) Responder
Defined as a subject who experiences a reduction from baseline in post-bronchodilator FEV1 of ≥12%
Measured: Month 12
Secondary outcomes (9)
Residual Volume (RV) + St George's Respiratory Questionnaire for COPD (SGRQ-C)
Responder rate
Measured: Months 3 and 12
St. George's Respiratory Questionnaire for COPD (SGRQ-C) Responder Rate
SGRQ-C total score
Measured: Months 3, 6, 12 and Years 2, 3
Modified Medical Research Council (mMRC) Responder Rate
mMRC dyspnea score
Measured: Months 3, 6, 12 and Years 2, 3
COPD Assessment Test (CAT) Responder Rate
CAT Score
Measured: Months 3, 6, 12 and Years 2, 3
Forced Expiratory Volume in the first second (FEV1) Responder Rate
FEV1
Measured: Months 3, 6, 12 and Years 2, 3
6-minute walk distance (6MWD)
6MWD
Measured: Months 3, 6, 12 and Years 2, 3
Ratio of residual volume (RV)/ total lung capacity (TLC) Responder Rate
Ratio RV/TLC
Measured: Months 3, 6, 12 and Years 2, 3
Residual Volume (RV) Responder Rate
RV
Measured: Months 3, 6, 12 and Years 2, 3
Forced Vital Capacity (FVC) Responder Rate
FVC
Measured: Months 3, 6, 12 and Years 2, 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start15 Jul 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, two arm, parallel group, concurrently controlled, open-label, multi-center clinical trial following subjects to 3 years.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Apreo Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerard Criner, MD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891755
- Sponsor's protocol ID
- CIP-0028
- Acronym
- BREATHE-3
- Status last verified
- Oct 2026
- First submitted
- 18 Mar 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No