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Bronchoscopic release of trapped air in hyperinflated emphysematous lungs

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

Not applicable Interventional Apreo Health, Inc. · NCT06891755

This trial tests if placing permanent Apreo BREATHE airway scaffold implants by bronchoscopy, together with usual medical care, helps adults with COPD and emphysema who remain short of breath from lung hyperinflation.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment250 (estimated)
Ages40 Years to 84 Years
SexAll
SponsorApreo Health, Inc. Industry-sponsored
Drugs / interventionschemotherapy
Locations22 sites (Birmingham, Alabama and 21 other locations)
Trial IDNCT06891755 on ClinicalTrials.gov

What this trial studies

This is a prospective, open-label, randomized, parallel-group trial enrolling up to 250 adults with COPD and emphysema at up to 25 centers in the United States and Europe with 3 years of follow-up. After a site roll-in phase, up to 200 subjects will be randomized 2:1 to receive either optimal medical management alone or optimal medical management plus bronchoscopic bilateral placement of up to three Apreo BREATHE airway scaffolds per lung. Target airways will be chosen using quantitative CT and pulmonary function criteria, and outcomes will include safety, measures of hyperinflation, symptoms, and exercise capacity. All participants receive guideline-based optimal medical management per the 2024 GOLD recommendations.

Who should consider this trial

Good fit: Ideal candidates are adults 40–84 years old with BMI 18–32, persistent dyspnea (mMRC ≥2) despite pulmonary rehabilitation and optimal medical therapy, measurable bilateral emphysema and hyperinflation on CT with specified destruction and RV thresholds, and the ability to walk ≥100 meters in six minutes.

Not a fit: Patients with mild emphysema or without significant hyperinflation, a BMI outside 18–32, FEV1/FVC ≥0.70, inability to undergo bronchoscopy, or major comorbidities are unlikely to receive benefit from this intervention.

Why it matters

Potential benefit: If successful, the implant could reduce trapped air and breathlessness, improving exercise capacity and quality of life for selected patients.

How similar studies have performed: Other bronchoscopic lung-volume-reduction approaches such as endobronchial valves and coils have shown benefit in selected emphysema patients, but the permanent Apreo BREATHE airway scaffold is a newer device with limited prior data.

Eligibility criteria

Show full inclusion / exclusion 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 bilateral heterogenous emphysema and pre-procedure post-bronchodilator RV ≥ 180% predicted, or one lung with homogenous emphysema and pre-procedure postbronchodilator RV ≥ 200% predicted.
  9. Subject has pre-procedure post-bronchodilator FEV1/ FVC \< 0.70.
  10. Subject has a pre-procedure post-bronchodilator FEV1 percent predicted of ≥15% and ≤45%.
  11. Subject has pre-procedure post-bronchodilator RV/TLC ≥ 0.55.
  12. Subject has pre-procedure DLCO ≥ 20%.
  13. Subject has been receiving optimal medical management tailored to subject needs for 2 months prior to enrollment.
  14. 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.
  15. 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.
  16. 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.
  17. 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.

Where this trial is running

Birmingham, Alabama and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions COPDEmphysemaApreoBREATHE SystemHyperinflationAir-trappingApreo BREATHE Airway ScaffoldBREATHE Implant
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.