March 13, 2007
UI Researchers Announce New Emphysema Treatment Study
Researchers at the University of Iowa Hospitals and Clinics 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 significant new, minimally invasive option for those suffering with advanced widespread emphysema.
The study focuses on a procedure called airway bypass that involves creating pathways in the lung for trapped air to escape and, in turn, relieve emphysema symptoms including shortness of breath.
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 cannot 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 emphysema patients. Patients are often in poor physical condition, struggling with each breath," stated Geoffrey McLennan, M.D., principal investigator of the study at UI Hospitals and Clinics. "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. Patients could see an immediate improvement in dyspnea (shortness of breath).
"The airway bypass procedure could be an excellent 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," McLennan said.
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.
Emphysema affects an estimated 60 million people worldwide with more than three million sufferers in the United States. There is no cure for emphysema.
UI Hospitals and Clinics is currently recruiting patients for the EASE Trial. Involvement in the study will last from approximately 15 months up to five years (depending on if the patient is randomized to the control or the treatment group) and include eight 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 age 35 has been diagnosed with advanced widespread emphysema and no longer smokes (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 http://www.EASEtrialUS.com.
-- About Broncus Technologies:
Broncus Technologies 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 http://www.broncus.com.
NOTES TO EDITORS:
For more information on the EASE Trial at UI Hospitals and Clinics or to schedule an interview with Geoffrey McLennan, M.D., contact Tom Moore at 319-356-3945 or firstname.lastname@example.org.
For general information on the EASE Trial, airway bypass, or Broncus Technologies, please contact Meghan Oreste at 617-823-1441 or email@example.com.
For questions about enrolling in the trial call 866-431-3273 or visit http://www.EASEtrialUS.com
McLennan has no personal direct financial affiliation with Broncus Technologies Inc. The study is sponsored by Broncus Technologies, Inc. Broncus and Exhale are trademarks of Broncus Technologies, Inc.
STORY SOURCE: Joint Office for Marketing and Communications, University of Iowa Health Care, 200 Hawkins Drive, Room E110 GH, Iowa City, Iowa 52242-1009
MEDIA CONTACT: Tom Moore, 319-356-3945, firstname.lastname@example.org.