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

Launched by APREO HEALTH, INC. · Mar 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Apreo BREATHE system, which is designed to help patients with chronic obstructive pulmonary disease (COPD) and emphysema who have trouble breathing due to trapped air in their lungs. The goal is to determine if this device is safe and effective in improving breathing for adults who continue to experience shortness of breath despite receiving the best medical treatment available. The study will involve up to 250 participants at various centers in the U.S. and Europe, and those who join will be monitored for three years to see how well they respond to the treatment.

To be eligible for the trial, participants must be between 40 and 84 years old and have specific lung conditions that can be measured through imaging tests. They should have completed a rehabilitation program for their lungs within the past year and be able to walk a certain distance in six minutes. It's also important that participants have not smoked recently and have received vaccinations against respiratory infections. If you or someone you know is interested in this study, it's crucial to know that enrollment has not yet started, and participants will receive close follow-up care throughout the trial.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • 1. Subject is at least 40, but not older than 84, years of age.
• • 2. Subject has body mass index (BMI) of between 18 and 32, inclusive.
• • 3. Subject has completed a documented pulmonary rehabilitation program within 12 months prior to Baseline.
• • 4. Subject has mMRC score ≥ 2.
• • 5. Subject can walk ≥100 meters in 6 minutes.
• • 6. 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.
• • 7. 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.
• • 8. Subject has at least one target lobe with destruction score(s) of ≥35% with \< -950 Hounsfield units on thin slice inspiratory CT, as determined by the CT core lab.
• • 9. Subject has pre-procedure post-bronchodilator RV ≥ 180% predicted.
• • 10. Subject has pre-procedure post-bronchodilator FEV1/ FVC \< 0.70.
• • 11. Subject has a pre-procedure post-bronchodilator FEV1 percent predicted of ≥15% and ≤45%.
• • 12. Subject has pre-procedure post-bronchodilator RV/TLC ≥ 0.55.
• • 13. Subject has pre-procedure DLCO ≥ 20%.
• • 14. Subject has been receiving optimal medical management tailored to subject needs for 2 months prior to enrollment.
• • 15. 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.
• • 16. 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.
• • 17. 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.
• • 18. Subject has provided written informed consent.
• • Exclusion Criteria
• • 1. Subject has known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis).
• • 2. Subject has a steroid-dependent condition requiring (e.g. ≥10 mg oral corticosteroid per day).
• • 3. 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.
• • 4. Subject has arterial or capillary blood on room air: PaCO2 \> 50 mmHg (8 kPa) or PaO2 ≤ 45 mmHg (6 kPa).
• • 5. Subject has had ≥2 hospitalization for acute exacerbations of COPD or ≥3 moderate exacerbations/respiratory infections in the year prior to enrollment.
• • 6. 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).
• • 7. 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).
• • 8. Subject has presence of a giant bulla (≥ 30% of hemithorax).
• • 9. Subject has significant symptom burden due to currently active adult asthma based on GINA criteria and/or chronic bronchitis as their primary diagnosis.
• • 10. 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.
• • 11. Subject has clinically significant bronchiectasis (\>4 TBS / 45mL mucus production/day, per subject estimate) influencing subject's COPD symptoms.
• • 12. Subject has unresolved lung cancer.
• • 13. 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.
• • 14. 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.
• • 15. Subject has invasive mechanical ventilator dependency.
• • 16. Subject is pregnant, lactating, or of childbearing potential and plans to become pregnant during study duration.
• • 17. Subject has known hypersensitivity to Nitinol (nickel-titanium alloy) or its constituent metals (nickel or titanium).
• • 18. Subject is significantly immunocompromised, such as organ transplant recipients, those with congenital immune deficiencies, AIDS, or severe rheumatoid arthritis.
• • 19. Subject has sensitivity or allergy to medications necessary for bronchoscopy under general anesthesia.
• • 20. Subject is currently participating in another study involving an investigational product that could confound the study results or affect the subject's COPD symptoms.
• • 21. 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.