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

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

Keywords

ClinConnect Summary

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 gro...

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.

Trial Officials