Temple University Hospital has become the first site in the United States to treat a patient as part of the BREATHE-3 clinical trial. The study is focused on evaluating a new bronchoscopic device, the Apreo BREATHE Airway Scaffold, for patients with severe emphysema and hyperinflation.
The BREATHE-3 trial is a Phase 3, multicenter, randomized, interventional, controlled study. It will assess both safety and efficacy of the implantable airway scaffold, which received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in May 2024. The procedure involves placing up to six self-expanding scaffolds via bronchoscopy and fluoroscopy for those assigned to the treatment group. The device is designed to allow trapped air in diseased lungs to move more freely, helping it escape and reducing airway obstruction.
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 serving as principal investigator for this trial. Dr. Criner’s team treated the first patient on August 13.
“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 form of chronic obstructive pulmonary disease (COPD), characterized by damage to air sacs in the lungs that makes breathing difficult over time. According to data from the American Lung Association, more than three million people in the United States are living with emphysema.
The BREATHE-3 trial aims to enroll up to 250 participants across 25 centers in both the U.S. and Europe over three years. Eligible participants are adults aged 40–84 who have severe COPD-related emphysema accompanied by significant breathlessness. The primary goal is an improvement from baseline in Forced Expiratory Volume in one second (FEV1) by at least 12 percent after one year.
Dr. Criner and his team at Temple Lung Center have previously led research into treatments for COPD and emphysema over several decades. In August 2018, Temple was first in the nation to perform minimally invasive BLVR using Zephyr Endobronchial Valve after FDA approval; similar work followed with Spiration Valve System in March 2019.
“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—Dean at Lewis Katz School of Medicine—said: “Innovative clinical research like the BREATHE-3 trial is central to the mission of the Lewis Katz School of Medicine,” she stated.“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 withthe opportunityto learn atthe cutting edgeof medicine.”
Editor’s Note: Dr.Criner has an ongoing financial interestin anda consulting relationshipwithApreo Health.This financial interestis being managedin accordancewiththe Lewis Katz Schoolof MedicineatTemple University’sconflict-of-interest policy.For more information aboutthe University’spolicy,email [email protected].
