Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3 (NCT06891755) | Clinical Trial Compass
RecruitingNot Applicable
Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3
United States250 participantsStarted 2025-07-15
Plain-language 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?
Who can participate
Age range40 Years – 84 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
What they're measuring
1
Forced Expiratory Volume in 1 second (FEV1) Responder
. 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).