Investigational treatment for advanced widespread emphysema

Apr 2 2008

Researchers at Suburban Lung Associates and the Chicago Chest Center recently announced the start of the EASE (Exhale Airway Stents for Emphysema) Trial to explore an investigational treatment for advanced widespread emphysema.

The trial focuses on airway bypass, a minimally invasive bronchoscopic procedure designed to help patients with emphysema/COPD (chronic obstructive pulmonary disease) breathe more easily.

Central DuPage Hospital is the only site for the EASE trial in the Chicago area. “Airway bypass could be groundbreaking because it is a potential non-surgical treatment for the patient with diffuse emphysema,” states Dr. Kevin Kovitz, interventional pulmonologist and principal investigator of the study at the Central DuPage Hospital site. “Emphysema, which permanently destroys lung function, is such a devastating disease, and any potential new treatment option could offer substantial relief to the millions who struggle with each breath.”

During the airway bypass 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. Patients could see an immediate improvement in shortness of breath.

Emphysema, a type of COPD, is a chronic, progressive and irreversible lung disease characterized by the destruction of lung tissue. The loss of the lungs' natural elasticity and the collapse of airways in the lung combine to leave emphysema sufferers unable to get air out of their lungs. As a result, 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 emphysema and there is no cure.

“If proven, 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 Dr. Kovitz.

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 approximately two hour procedure involves placing up to six drug-eluting stents.

Although this procedure is still under clinical investigation, feasibility data suggest it may hold promise for patients with emphysema. Results from the open-label Exhale Drug-Eluting Stent feasibility study were published in the October issue of the Journal of Thoracic and Cardiovascular Surgery. Positive results included a statistically significant reduction in the amount of air trapped in the lungs and an improvement in breathing for patients at six months after the airway bypass procedure. The EASE trial is designed to see if these results hold in a randomized, controlled trial. That is, a group of patients will receive the stents and others will not. This will allow investigators to see if the stents improve function and quality of life. All participants will help gather information valuable to their fellow emphysema sufferers.