Temple University Hospital has become the first site in the United States to treat a patient in the BREATHE-3 clinical trial, a Phase 3 study evaluating the Apreo BREATHE Airway Scaffold—a novel, implantable device designed to open airways and release trapped air in patients with severe emphysema and hyperinflation.
Led at Temple by Gerard J. Criner, MD, FACP, FACCP, Chair and Professor of Thoracic Medicine and Surgery at the Lewis Katz School of Medicine and Director of the Temple Lung Center, the trial could offer a new non-surgical treatment for patients who are not candidates for existing options like endobronchial valves.
The multicenter trial will enroll up to 250 participants at 25 sites in the U.S. and Europe and follow them for three years. Eligible participants are between the ages of 40 and 84, have severe COPD-related emphysema, and experience significant breathlessness. The primary measure of success will be an improvement in lung function (FEV1) of at least 12% after one year.
This milestone builds on Temple’s leadership in advancing treatments for COPD and emphysema. Temple was the first U.S. hospital to perform minimally invasive bronchoscopic lung volume reduction with the Zephyr® Endobronchial Valve in 2018 and the Spiration® Valve System in 2019, both following pivotal trials led by Dr. Criner.
“With each new clinical trial, we take a step forward for our patients,” Dr. Criner said. “Each study is an attempt to improve their outcomes and expand their alternatives for care.”
Amy J. Goldberg, MD, FACS, The Marjorie Joy Katz Dean, Lewis Katz School of Medicine, noted, “Innovative clinical research like the BREATHE-3 trial is central to the mission of the Lewis Katz School of Medicine. This milestone reflects our commitment to leading research that changes lives, here in Philadelphia and around the world.”