image: Gerard J. Criner, MD, FACP, FACCP, Chair and Professor of Thoracic Medicine and Surgery at the Lewis Katz School of Medicine at Temple University and Director of the Temple Lung Center, is a principal investigator for the BREATHE-3 study and treated the first patient with his team.
Credit: Temple Health
(Philadelphia, PA) – Temple University Hospital has treated the first patient in the U.S. in the BREATHE-3 clinical trial, which will evaluate a novel bronchoscopic device designed to open airways and release trapped air in patients with severe emphysema and hyperinflation.
The Phase 3, multicenter, randomized, interventional, controlled trial will assess the safety and efficacy of the Apreo BREATHE Airway Scaffold, an implantable, tissue-sparing device that was granted U.S. Food and Drug Administration (FDA) Breakthrough Device Designation in May 2024. During the minimally invasive procedure, up to six of the self-expanding scaffolds (three per lung) are placed using bronchoscopy and fluoroscopy for those randomized to the treatment group. This design allows trapped air to move back and forth, relaxing the airways and enabling trapped air to escape.
Gerard J. Criner, MD, FACP, FACCP, Chair and Professor of Thoracic Medicine and Surgery at the Lewis Katz School of Medicine at Temple University and Director of the Temple Lung Center, is a principal investigator for the BREATHE-3 study and treated the first patient with his team on August 13th.
“Only 20-30% of screened patients with severe emphysema and hyperinflation are candidates for existing treatment options like bronchoscopic lung volume reduction (BLVR) with endobronchial valves,” said Dr. Criner. “These patients have a reduced quality of life, with symptoms that seriously impact their day-to-day activities. This approach could offer a new, non-surgical option for these underserved patients who do not qualify for the valves.”
Emphysema is a type of chronic obstructive pulmonary disease (COPD) that makes it hard to breathe. It is progressive and worsens over time. The condition affects the air sacs in the lungs, making it harder for the lungs to move oxygen in and carbon dioxide out of the body. Individuals with emphysema may experience frequent coughing (sometimes with mucus) or wheezing, shortness of breath, and tightness in the chest. According to the American Lung Association, more than 3 million people in the U.S. are living with emphysema.
The BREATHE-3 clinical trial will enroll up to 250 participants across 25 centers in the U.S. and Europe and will follow them for three years. Those between the ages of 40-84 with severe COPD-related emphysema and significant breathlessness may be eligible to participate. The trial’s primary endpoint will be improvement from baseline in FEV1 (Forced Expiratory Volume in 1 second) of greater than or equal to 12 percent after one year.
This study will build on past efforts of Dr. Criner and the Temple Lung Center, who have been at the forefront of research into treatments for COPD and emphysema for over 35 years. In August 2018, Temple became the first U.S. hospital to perform minimally invasive BLVR using the Zephyr® Endobronchial Valve (Zephyr® EBV®) following approval by the FDA. Then, in March 2019, Dr. Criner and the Temple Lung Center did it again, this time with the Spiration® Valve System, following FDA approval. In both instances, Dr. Criner was a principal investigator for the major international clinical trials that ultimately led to the valves’ approval, a significant advancement beyond traditional lung volume reduction surgery (LVRS).
“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.”
“Innovative clinical research like the BREATHE-3 trial is central to the mission of the Lewis Katz School of Medicine,” said Amy J. Goldberg, MD, FACS, The Marjorie Joy Katz Dean, Lewis Katz School of Medicine. “This milestone reflects our commitment to leading research that changes lives—here in Philadelphia and around the world. I’m proud of Dr. Criner and the Temple Lung Center team for pioneering the next generation of treatments for emphysema and COPD, and for providing our students and trainees with the opportunity to learn at the cutting edge of medicine.”
Editor’s Note: Dr. Criner has an ongoing financial interest in and consulting relationship with Apreo Health. This financial interest is being managed in accordance with the Lewis Katz School of Medicine at Temple University’s conflict of interest policy. For more information about the University’s policy, please contact coisom@temple.edu.
###
About Temple Health
Temple University Health System (Temple Health) is a $2.9 billion academic health system dedicated to providing access to quality patient care and supporting excellence in medical education and research. Temple Health includes Temple University Hospital (TUH)-Main Campus; TUH-Episcopal Campus; TUH-Jeanes Campus; TUH-Northeastern Campus; Temple University Hospital – Fox Chase Cancer Center Outpatient Department; TUH-Northeastern Endoscopy Center; The Hospital of Fox Chase Cancer Center, together with The Institute for Cancer Research, an NCI-designated comprehensive cancer center; Fox Chase Cancer Center Medical Group, Inc., The Hospital of Fox Chase Cancer Center’s physician practice plan; Temple Health – Chestnut Hill Hospital; Temple Women & Families; Temple Transport Team, a ground and air-ambulance company; Temple Physicians, Inc., a network of community-based specialty and primary-care physician practices; and Temple Faculty Practice Plan, Inc., Temple Health’s physician practice plan. Temple Health is affiliated with the Lewis Katz School of Medicine at Temple University.
Temple Health refers to the health, education and research activities carried out by the affiliates of Temple Health and by the Katz School of Medicine. Temple Health neither provides nor controls the provision of health care. All health care is provided by its member organizations or independent health care providers affiliated with Temple Health member organizations. Each Temple Health member organization is owned and operated pursuant to its governing documents.
Non-discrimination notice: It is the policy of Temple University Hospital and The Hospital of Fox Chase Cancer Center, that no one shall be excluded from or denied the benefits of or participation in the delivery of quality medical care on the basis of race, ethnicity, religion, sexual orientation, gender, gender identity/expression, disability, age, ancestry, color, national origin, physical ability, level of education, or source of payment.