Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3

NCT06891755 | Recruiting DMC FDA Device

• 1 other identifier: CIP-0028
• Study Type: interventional
• Target: 250
• Locations: 4 countries
• Sites: 22

Brief 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?

Conditions

COPD; Emphysema

Keywords

Apreo; COPD; Emphysema; BREATHE System; Hyperinflation; Air-trapping; Apreo BREATHE Airway Scaffold; BREATHE Implant; Airway Scaffold; Apreo Health

Outcome Measures

Primary Outcomes (1)

• Forced Expiratory Volume in 1 second (FEV1) Responder

  Defined as a subject who experiences a reduction from baseline in post-bronchodilator FEV1 of ≥12%

  Month 12

Secondary Outcomes (9)

• Residual Volume (RV) + St George's Respiratory Questionnaire for COPD (SGRQ-C)

  Months 3 and 12

• St. George's Respiratory Questionnaire for COPD (SGRQ-C) Responder Rate

  Months 3, 6, 12 and Years 2, 3

• Modified Medical Research Council (mMRC) Responder Rate

  Months 3, 6, 12 and Years 2, 3

• COPD Assessment Test (CAT) Responder Rate

  Months 3, 6, 12 and Years 2, 3

• Forced Expiratory Volume in the first second (FEV1) Responder Rate

  Months 3, 6, 12 and Years 2, 3

Study Arms (2)

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.

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.

Other: Optimal Medical Management (OMM)

Interventions

Apreo BREATHE Airway Scaffold DEVICE

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).

Apreo implants + Optimal Medical Management

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.

Optimal Medical Management

Eligibility Criteria

• Age: 40 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Apreo Health, Inc.: lead

Study Sites (22)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

Banner Health

Gilbert, Arizona, 85234, United States

RECRUITING

University of California at Davis

Sacramento, California, 95817, United States

RECRUITING

Mayo Clinic

Jacksonville, Florida, 32224, United States

RECRUITING

Orlando Health

Orlando, Florida, 32806, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

OSF St Francis Medical Center

Peoria, Illinois, 61637, United States

RECRUITING

University of Kansas Medical Center Research Institute

Kansas City, Kansas, 66160, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44103, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Clinical Research Associates of Central Pennsylvania

DuBois, Pennsylvania, 15801, United States

RECRUITING

Temple University

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Houston Methodist/Primary Critical Care

Houston, Texas, 77030, United States

RECRUITING

Inova Health Care Services

Falls Church, Virginia, 22042, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Karl Landsteiner Institute - Klink Floridsdorf

Vienna, A-1210, Austria

RECRUITING

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

RECRUITING

St. Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

RECRUITING

Royal Brompton Hospital

London, SW36JY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gerard Criner, MD

  Temple University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cindy Holtz

CONTACT

650-326-2656; cindy.holtz@apreohealth.com

Nina Mohmood

CONTACT

nina.mohmood@apreohealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, two arm, parallel group, concurrently controlled, open-label, multi-center clinical trial following subjects to 3 years.

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 24, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 24, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (18); NL (1); GB (2); AU (1)