Study of Apreo BREATHE Airway Scaffold with Optimal Medical Management to Treat Emphysema and COPD in Adults Aged 40 to 84

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Apreo BREATHE system as a treatment for adults with COPD and emphysema who experience breathlessness due to trapped air and lung hyperinflation despite receiving optimal medical care. This study involves up to 250 participants at centers in the United States and Europe, with a follow-up period of three years to determine if the device is safe and helpful. Participants will be randomly assigned in a 21 ratio to either receive the Apreo BREATHE Airway Scaffold implants along with optimal medical management or to receive only the optimized medical care. The treatment involves a single bronchoscopy procedure during which up to three implants per lung are placed to help open airways. All participants will continue receiving medical treatments such as smoking cessation support, vaccinations, medications, and pulmonary rehabilitation as recommended. There is also a Roll-In phase at each site enrolling a small number of subjects before randomization. Throughout the study, participants will attend follow-up visits at 1, 3, 6, and 12 months, and then at 2 and 3 years after treatment or randomization. These visits include evaluations of lung function, questionnaires about respiratory health, CT scans to assess lung structure, and monitoring for any adverse effects. Participants in the control group may opt to receive the implant treatment after their 12-month visit, with additional follow-up assessments after crossover. The main outcome measured is the improvement in lung function, specifically Forced Expiratory Volume in 1 second FEV1 at 12 months.

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