First U.S. Patient Treated in Apreo’s BREATHE-3 Trial

Temple University Hospital has treated the first U.S. patient in the randomized BREATHE-3 clinical trial, which is evaluating Apreo Health Inc.’s bronchoscopic device that opens airways and releases trapped air in patients with severe emphysema and hyperinflation.

The Phase 3, multicenter, interventional, controlled trial is assessing 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 last May. 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.

The BREATHE-3 study’s principal investigator is Gerard J. Criner, M.D., 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. He and his team treated the first patient on Aug. 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,” Dr. Criner said. “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. A progressive condition, it affects the lungs’ air sacs, 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 United States live with emphysema.

The BREATHE-3 clinical trial will enroll up to 250 participants across 25 centers in the United States 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 one second) of greater than or equal to 12% 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 COPD and emphysema treatments for more than 35 years. In August 2018, Temple became the first U.S. hospital to perform minimally invasive BLVR using the Zephyr Endobronchial Valve (Zephyr EBV) after its U.S. Food and Drug Administration (FDA) approval. Dr. Criner and the Center repeated the milestone in March 2019, this time with the Spiration Valve System, after FDA authorization. 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 stated. “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, M.D., 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.”

* Dr. Criner has an ongoing financial interest in and consulting relationship with Apreo Health.