October 27, 2008 (Baltimore, MD)Franklin Square Hospital Center announces the start of the EASE (Exhale Airway Stents for Emphysema) Trial to explore an investigational treatment for advanced widespread emphysema/COPD. The trial focuses on airway bypass, a 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 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 dyspnea (shortness of breath).
"We are excited to be part of this study because currently there are limited treatment options for emphysema. Patients are often in poor physical condition, struggling with each breath," states William Krimsky, MD, director of Interventional Pulmonology at Franklin Square and principal investigator of the study. "By creating new pathways for airflow with the airway bypass procedure, we hope to reduce hyperinflation and improve lung function. If patients can breathe easier it is likely to improve their quality of life."
Emphysema, a component 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 make exhalation ineffective, leaving emphysema sufferers with hyperinflation because they are unable to get air out of their lungs. 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 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 Krimsky. "Given that emphysema, which permanently destroys lung function, is such a devastating disease -- any potential new treatment option could offer substantial relief to the millions who suffer."
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 two hours.
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 2007 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.
|Contact: Meghan Oreste|