EASE Trial to Evaluate Emphysema Treatment

Researchers at National Jewish Health poking holes in the lungs of emphysema patients to learn that helps them breathe more easily. Destruction of lung tissue caused by emphysema can leave lungs stiff and overinflated with air that cannot escape. The holes, kept open by small stents inserted during a minimally invasive procedure, could relieve the hyperinflation of the lungs, allowing the healthy parts of the lungs to more easily inflate and take in air.

“Advanced emphysema patients are often in poor physical condition, struggling with each breath,” said Ali Musani, MD, FCCP, principal investigator of the study at National Jewish. “If patients can breathe easier it is likely to improve their quality of life.”

During the 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.

“Airway bypass is groundbreaking because right now it is the only treatment being studied to help emphysema patients whose disease has destroyed tissue throughout the lung,” said Dr. Musani. “If successful this minimally invasive procedure would help those who would not otherwise be considered for or benefit from lung volume reduction surgery.”

Emphysema, a component of chronic obstructive pulmonary disease (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.

National Jewish is currently recruiting patients for the EASE trial. The study will last from 15 months to 5 years, depending if the patient is randomized to the control or the treatment group. During the airway bypass procedure physicians will 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.

Although this procedure is still under clinical investigation, feasibility data suggest it may hold promise for patients with emphysema. Results from the feasibility study were published in the October 2007 issue of the Journal of Throacic 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.

“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,” said Dr. Musani.

To learn more about the Ease trial or to enroll in the study, call 303-398-1911 or outside Colorado at 866-431-3273.

About National Jewish Health

National Jewish Health is known worldwide for treatment of patients with respiratory, immune and related disorders, and for groundbreaking medical research. Founded in 1899 as a nonprofit hospital, National Jewish provides the best integrated and innovative care for patients and their families; seeks to understand and find cures for the diseases we research; and educates and trains the next generation of healthcare professionals to be leaders in medicine and science. We pursue this vision by pioneering individualized medicine programs which embrace the paradigm shift from reactive medicine to proactive, personalized healthcare. For 10 consecutive years, U.S. News & World Report has ranked National Jewish the No. 1 respiratory hospital in the nation. Scholarly publisher Thomson Scientific has ranked National Jewish among the 25 most influential research institutions in the world in its areas of focus. Further information can be found by visiting www.nationaljewish.org.

About Broncus Technologies, Inc.

Broncus Technologies, Inc. is helping people breathe easier by developing bronchoscopic interventions for the treatment of chronic lung diseases. Founded in 1997, Broncus Technologies has developed the Exhale® Drug-Eluting Stent for use in the airway bypass procedure, a minimally-invasive procedure to treat emphysema. Airway bypass creates new pathways in the lung for air to escape and may potentially improve the breathing abilities of patients with emphysema. Broncus Technologies is currently conducting the pivotal EASE Trial to evaluate the safety and efficacy of airway bypass in the treatment of advanced widespread emphysema. For more information visit www.broncus.com.