Novel Airway Scaffolds Show Promise in BREATHE-3 Trial for Severe Emphysema Treatment
Key Insights
The BREATHE-3 trial is testing self-expanding nitinol airway scaffolds (search) as a minimally invasive treatment for severe emphysema (search)-related hyperinflation (search) at select centers including Temple University and UAB (search).
Initial results from 60 patients showed significant improvements in lung function, with trapped air decreasing by an average of 753 milliliters at six months, along with better quality of life and exercise capacity.
The scaffolds demonstrated a favorable safety profile with no pneumothorax (search) events, potentially offering treatment options for the nearly 70% of severe emphysema (search) patients who don't qualify for existing procedures.
A novel minimally invasive treatment for severe emphysema (search) is showing promising results in the BREATHE-3 pivotal clinical trial, offering potential hope for patients who have exhausted traditional treatment options. The international study is testing self-expanding nitinol airway scaffolds (search) that address the root cause of hyperinflation (search) in emphysema patients.
Addressing Unmet Medical Need
In emphysema (search), a type of Chronic Obstructive Pulmonary Disease (search) (COPD (search)), the primary challenge extends beyond breathing in. "They can't empty their lungs (search) fully, and that makes them more short of breath, limits their activities of daily living," explains Dr. Gerard Criner, director of the Temple Lung Center (search), one of the key test sites for the device.
Currently, patients have two main treatment options: surgical removal of diseased lung sections, typically about 30% of each upper lobe, or implantation of tiny one-way valves that allow trapped air to escape. However, Dr. Criner notes that nearly 70% of patients suffering from severe emphysema (search) don't qualify for either procedure.
Innovative Scaffold Technology
The BREATHE-3 trial uses permanent airway scaffolds that function as bronchoscopic implants designed to reinforce and expand collapsed airways (search). "This is a device like a scaffold that's placed in the airway to prop the airway open in that area of emphysema (search) to let the patient deflate," Dr. Criner explains.
The scaffolds are implanted under general anesthesia using a bronchoscope, requiring only a one-night hospital stay. Five different lengths are available to accommodate varying treatment areas, and both sides of the lungs (search) can be treated simultaneously. "Treating both sides prevents the other side from getting bigger from hyperinflation (search) because air is like water, it goes to the path of least resistance," Dr. Criner notes.
Encouraging Clinical Results
Initial results from first-in-human studies across multiple international centers have demonstrated significant clinical benefits. Among 60 patients treated per protocol with the permanent airway scaffolds, researchers observed meaningful improvements in lung function, with residual volume—the amount of air trapped in the lungs (search)—decreasing by an average of 753 milliliters at six months.
Dr. Surya Bhatt, professor in the Department of Medicine at UAB (search) and director of the Center for Lung Analytics and Imaging Research, is leading the study at his institution. "For patients like Ms. Hill who have struggled with severe emphysema (search), hyperinflation (search) creates a debilitating cycle where air becomes trapped in the lungs (search), making it progressively harder to breathe," said Bhatt. "These airway scaffolds offer a new approach by keeping the airways (search) open, essentially creating a pathway for trapped air to escape."
One of UAB (search)'s first participants, P. Hill, described the transformative impact: "I can now breathe all the way to my belly button." Her FEV1—the amount of air she can forcefully exhale in one second—has improved significantly, and she has lost about a liter of trapped air that was previously preventing her lungs (search) from functioning properly. "Before this treatment, I felt like I could never get a full breath, and now I feel like I can fill my lungs," Hill said. "It's given me my life back."
Safety Profile and Broader Applicability
The scaffolds have demonstrated a favorable safety profile with minimal complications. Notably, the treatment appears to be free of causing collapsed lungs (search), which affect nearly a third of valve recipients. The scaffolds showed excellent stability with minimal migration, and airway patency was well-maintained through the six-month follow-up period.
"What makes this treatment particularly promising is that it may benefit a broader range of emphysema (search) patients than currently available options," said Bhatt. "Many existing treatments are limited to patients with specific emphysema patterns or require the fissures or partitions between upper and lower lung lobes to be intact without any holes."
Trial Enrollment and Future Outlook
The BREATHE-3 trial at UAB (search) is actively seeking participants aged 40-84 years with COPD (search) and severe emphysema (search) with significant hyperinflation (search). Eligible patients must have post-bronchodilator FEV1 between 15% and 45% of predicted, residual volume greater than 180% of predicted, and significant shortness of breath despite optimal medical management.
The trials will continue at participating centers in the United States and Europe for the next few years before the scaffold's manufacturers seek final government approval. Dr. Criner summarizes the trial's objectives: "Enrich the benefit and decrease the risk."