The BREATHE-3 trial is a pioneering phase 3 pivotal clinical study investigating the impact of a novel, experimental device designed to open the airways within a patient’s lungs and release trapped air in patients battling severe emphysema and COPD.The University of Alabama at Birmingham is now enrolling patients in the BREATHE-3 trial, a pioneering - pivotal clinical study investigating a innovative, experimental treatment for severe emphysema-related hyperinflation.
Hyperinflation refers to the lung’s increase in size due to the trapped air that has caused them to expand.
The BREATHE-3 trial uses self-expanding nitinol airway scaffolds that are placed bronchoscopically to connect emphysematous lung tissue with central airways. Unlike other emphysema treatments, these permanent scaffolds are designed to reinforce and expand collapsed airways, allowing trapped air to escape during exhalation. This addresses the root cause of hyperinflation—a major contributor to shortness of breath and reduced quality of life in severe emphysema patients.
Emphysema is a type of Chronic Obstructive Pulmonary Disease. This chronic condition causes damage to the lung’s alveoli, or air sacs. This specifically results in a decreased capacity to expel carbon dioxide from the lungs after oxygen has been inhaled during normal breathing. This causes patients to have difficulty exhaling, shortness of breath and an overall decrease in the quality of breathing and life as the condition progresses.
UAB is one of select centers participating in this international clinical trial and has recently treated one of its first participants who has experienced quantifiable initial improvements in her breathing and quality of life since the procedure.
“I can now breathe all the way to my belly button,” said P. Hill. describing the changes she has experienced since receiving the innovative airway scaffold treatment.
These results cannot be guaranteed and participating in the research may not result in any benefit. These are preliminary results and cannot be presumed to be reproducible in all patients.
Surya Bhatt, M.D., a professor in the Department of Medicine at the University of Alabama at Birmingham Marnix E. Heersink School of Medicine and director of the Center for Lung Analytics and Imaging Research is leading the study at UAB. He says the improvements in Hill are very encouraging.
“For patients like Ms. Hill who have struggled with severe emphysema, hyperinflation creates a debilitating cycle where air becomes trapped in the lungs, making it progressively harder to breathe," said Bhatt. “These airway scaffolds offer a new approach by keeping the airways open, essentially creating a pathway for trapped air to escape.”
Bhatt says Hill’s results speak for themselves. 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 from functioning properly.
Initial results from the first-in-human studies conducted across multiple international centers have been highly encouraging. Among 60 patients treated ‘per protocol’ with these permanent airway scaffolds, researchers observed significant improvements in lung function, with residual volume—the amount of air trapped in the lungs—decreasing by an average of 753 milliliters at six months. Patients also experienced meaningful improvements in quality of life, exercise capacity, and symptom scores.
Serious risks such as collapsed lung are still possible. Other lung problems, and risks from the procedure to place the devices are also possible. Two devices with a different mechanism of action are FDA-approved for treatment of severe emphysema.
"What makes this treatment particularly promising is that it may benefit a broader range of emphysema 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 lobed to be intact without any holes.”
Bhatt says in addition to positive results, the safety profile has also been favorable, with a low risk of serious complications and notably no pneumothorax or collapsed lung events—a common concern with other emphysema treatments such as endobronchial valves. The scaffolds demonstrated excellent stability with minimal migration, and airway patency was well-maintained through the six-month follow-up period.
“The airway scaffold approach may offer hope to patients who previously had few treatment options,” he said.
Ms. Hill says the improvements have been life changing.
“Before this treatment, I felt like I could never get a full breath, and now I feel like I can fill my lungs,” she said. “It's given me my life back.”
Bhatt is working alongside assistant professor of Pulmonary, Allergy, & Critical Care Medicine, Tetsuro Maeda, M.D., Elizabeth Plan, RRT and Abigail West, RRT.
The BREATHE-3 trial at UAB is actively seeking participants who meet the following criteria:
- Age 40-84 years
- COPD with severe emphysema with significant hyperinflation
- Post-bronchodilator FEV1 between 15% and 45% of predicted
- Residual volume greater than 180% of predicted
- Significant shortness of breath despite optimal medical management
Patients interested in learning more about the BREATHE trial or determining their eligibility should contact Elizabeth Plan at (205) 975-5294.