PHOENIX, AZ -- 02/11/08 --
Researchers at Pulmonary Associates 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 new, minimally invasive option for those
suffering with advanced widespread emphysema. The trial focuses on airway
bypass, a catheter-based 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 minimally invasive 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. The trial procedures will take
place at the John C. Lincoln North Mountain Hospital.
"We are excited to be part of this study because currently there are
limited treatment options for patients with severe emphysema. Patients
struggle with each breath," states Bernard Levine, MD, Principal
Investigator of the study at Pulmonary Associates. "If we can reduce
hyperinflation and improve lung function with airway bypass, patients will
be able to breathe easier leading to a better quality of life."
Emphysema, also known as COPD, is a characterized by a chronic,
progressive, and irreversible destruction of lung tissue. The lungs lose
their natural elasticity and are unable to exhale effectively, leading to
air trapping within the lungs and lung overinflation. 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 severe 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 Bernard Levine, MD,
Principal Investigator. "Currently our center is the only place in the
state of Arizona for patients to participate in the EASE Trial and
potentially undergo this procedure."
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.
Pulmonary Associates is currently recruiting patients for the EASE Trial.
The study will be a randomized controlled trial meaning that patients will
be randomly assigned to either a treatment or a smaller control group. Both
groups will undergo bronchoscopy but only the treatment group will receive
the airway bypass procedure. All subjects will have comprehensive medical
evaluation and laboratory studies and will receive at least 14 weeks of
pulmonary rehabilitation therapy. Involvement in the study will last from
approximately 15 months up to 5 years (depends on whether 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.
If you or someone you know over the age of 35 has been diagnosed with
advanced widespread emphysema and is no longer smoking (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.
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.
About the John C. Lincoln North Mountain Hospital
John C. Lincoln North Mountain Hospital was named one of the best hospitals
in the country for respiratory care by U.S. News and World Report.
Editors Notes
For more information on the EASE Trial at Pulmonary Associates or to
schedule an interview with Dr. Bernard Levine, please contact Pulmonary
Associates at 602-258 4951.
For general information on the EASE Trial, airway bypass, or Broncus
Technologies, please contact Meghan Oreste at 617-823-1441 or
moreste@comcast.net.
For questions about enrolling in the trial call 866-431-3273 or visit
www.EASEtrialUS.com.
Bernard Levine, MD 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.
