Researchers at Pulmonary Associates today announced the start of the EASE (Exhale Airway Stents for Emphysema) Trial, an international, multi-center clinical trial to explore an investigational treatment that may offer a new, minimally invasive option for those suffering with advanced widespread emphysema.
The trial focuses on airway bypass, a catheter-based bronchoscopic procedure designed to reduce lung hyperinflation and shortness of breath (the clinical hallmarks of emphysema/COPD) by making new pathways for trapped air to exit the lungs.
During the minimally invasive procedure, new openings are created in the airway wall connecting the damaged lung tissue to the natural airway. These pathways are supported and kept open by Exhale Drug-Eluting Stents – manufactured by Broncus Technologies, Inc. The trial procedures will take place at the John C. Lincoln North Mountain Hospital.
“We are excited to be part of this study because currently there are limited treatment options for patients with severe emphysema. Patients struggle with each breath,” states Bernard Levine, MD, Principal Investigator of the study at Pulmonary Associates. “If we can reduce hyperinflation and improve lung function with airway bypass, patients will be able to breathe easier leading to a better quality of life.”
Emphysema, also known as COPD, is a characterized by a chronic, progressive, and irreversible destruction of lung tissue. The lungs lose their natural elasticity and are unable to exhale effectively, leading to air trapping within the lungs and lung overinflation. Breathing becomes inefficient and patients have to work very hard just to breathe – making normal activities, like walking, eating or even bathing, difficult. There are few treatment options for most patients with severe emphysema and there is no cure.
“The airway bypass procedure could be an excellent option for those who are not suitable candidates for lung transplant surgery or who would possibly spend years on a lung transplant list,” states Bernard Levine, MD, Principal Investigator. “Currently our center is the only place in the state of Arizona for patients to participate in the EASE Trial and potentially undergo this procedure.”
Physicians commonly use bronchoscopes to examine the airways within the lungs. During the airway bypass procedure physicians will first use a Doppler probe inserted through the bronchoscope to identify a site in the airway that is away from blood vessels. A special needle is then used to make a small opening and an Exhale® Drug-Eluting Stent is placed in the passageway to keep it open. The procedure involves placing up to six drug-eluting stents. The total time of the procedure is approximately one to two hours.
This procedure is still under clinical investigation, but early data suggest it may hold promise for patients with emphysema.