Emphysema Treatment Study Begins

Researchers at Cedars-Sinai Medical Center to Study Airway Bypass Treatment for Emphysema

Cedars-Sinai - May 31, 2007

Researchers at Cedars-Sinai Medical Center announced today 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 study focuses on an experimental procedure called airway bypass designed to create pathways in the lung for trapped air to escape with the goal of relieving shortness of breath and other emphysema symptoms.

Emphysema 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 the emphysema sufferer with hyperinflation because they can't get air out of their lungs. With hyperinflation, breathing becomes inefficient and the patient is always short of breath. Even the most nominal physical activities become difficult for emphysema patients and many become dependent on oxygen therapy.

"We are excited to be part of this study because currently there are limited treatment
options for the emphysema patients," said Zab Mosenifar, M.D., Medical Director of
Cedars-Sinai Center for Chest Diseases and principal investigator of the study at Cedars-Sinai. "Patients are often in poor physical condition, struggling with each breath. 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."

During airway bypass, physicians will use a flexible bronchoscope to go through the
mouth into the airways. There the physician will create new small pathways and place
an Exhale® Drug-Eluting Stent - manufactured by Broncus Technologies, Inc. - to allow
the trapped air in the lung to escape.

"The airway bypass procedure could be a good option for those who would possibly spend years on a lung transplant list or not be suitable candidates for lung transplant surgery, which is one of the only other treatment options available for patients with this type of emphysema," said Mosenifar.

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 be beneficial to patients with emphysema.

Emphysema affects an estimated 60 million people worldwide with more than 3 million
sufferers in the United States. There is no cure for emphysema.

Cedars-Sinai is currently recruiting patients for the EASE Trial. Involvement in the study will last from approximately 15 months up to 5 years (depending on if the patient is randomized to the control or the treatment group) and include 8 to 16 physician appointments. All study-related medical procedures will be carried out at no charge to the patient and patients will be closely monitored throughout the trial. Participants will also receive at least 14 weeks of pulmonary rehabilitation therapy. If you or someone you know over the age of 35 have been diagnosed with advanced widespread emphysema and no longer smoke (or would be willing to stop smoking two months prior to the study), you may qualify to participate in this study. For more information please call 866-431-3273 or visit www.EASEtrialUS.com.