Virginia Hospital Center One of 20 US Institutions Participating ...
Virginia Hospital Center recently became part of the AIR2 Trial (Asthma Interventional Research), an international, multi-center clinical trial to explore a new investigational asthma procedure that may significantly change the course of asthma care. The study, headed up by Director of the Pulmonary Special Procedures Unit, David R. Duhamel, MD, and interventional pulmonologist Jeff B. Hales, MD, focuses on an outpatient procedure called Bronchial Thermoplasty(TM) to treat asthma.
"We are very excited about being involved in this study because it offers a unique opportunity for patients at Virginia Hospital Center to receive cutting-edge therapy only available at a handful of other institutions around the world," said Dr. Duhamel. "We believe that the results from the study have the potential to be very positive, and, in turn, may potentially open up a new treatment option for those that suffer with severe asthma."
Drs. Duhamel and Hales will use the Alair(R) System, developed by Asthmatx, Inc., to perform Bronchial Thermoplasty(TM), an investigative, minimally invasive outpatient procedure that reduces the amount of airway smooth muscle responsible for the constriction of airways in asthma patients. The procedure is performed through a standard flexible bronchoscope that is introduced through a patient's nose or mouth, and into their lungs. The small diameter Alair(R) catheter is delivered into the airways through the working channel of the flexible bronchoscope. The tip of the Alair catheter is expanded to contact the walls of targeted airways and deliver thermal energy to the airway walls in an effort to reduce the presence of airway smooth muscle, and thereby reduce the ability of treated airways to constrict.
"It's a very well designed study, randomized, controlled and double-blinded," says Dr. Duhamel. "If we can reduce the smooth muscle response that is narrowing the bronchi and establish a more open lumen to the airway, then we should be able to facilitate airflow, decrease symptoms and improve patients' pulmonary function and quality of life while potentially decreasing their need for other therapies."
The procedure is performed in the pulmonary special procedures unit and takes about an hour to complete, followed by post-procedure observations for approximately four hours. The procedure will be performed as an outpatient procedure under conscious sedation. No general anesthesia is used, no incision is necessary, and there is no need to stay overnight. Also, patients will remain on their current asthma treatment regimen through the duration of the study.
"This technique has been shown to decrease the amount of airway smooth muscle and also the hyper-responsiveness of the airways," said Dr. Hales. "Reduction of airway smooth muscle with Bronchial Thermoplasty is comparable to reduction in smooth muscle tone with bronchodilators, but is longer lasting, and potentially permanent.."
Study participants must be nonsmokers between the ages of 18 and 65, and must have moderately severe asthma that requires the equivalent of Advair 500 twice a day. Patients will be randomized at a 2:1 ratio to receive an active treatment of Bronchial Thermoplasty(TM).
Drs. Duhamel and Hales are careful to point out that there is no expectation that this new investigational procedure will cure asthma. However, it is hoped that this procedure could be useful in reducing the severity and frequency of asthma symptoms and improving quality of life for patients with asthma.
Dr. Duhamel anticipates enrolling up to 20 patients over the next year at Virginia Hospital Center as part of the 300 patient trial being conducted at many sites across the country including Duke University Medical Center, Cleveland Clinic Foundation, Brigham and Women's Hospital and Hospital of the University of Pennsylvania, as well as internationally at sites in Canada, Brazil, Australia and the United Kingdom.
Asthma is a disease involving greater than normal responsiveness of airways in the lungs to a variety of stimuli. This increased responsiveness can take the form of swelling of the airway wall, excess mucus production that can clog the airways, and significant narrowing of the airways when tiny muscles in the airway wall, called "airway smooth muscle", contract. It is one of the most common and costly diseases in the world, affecting more than 20 million people just in the U.S.; with an estimated two million emergency room visits, and 5,000 deaths per year. Currently, the only treatment for asthma sufferers is medication.
For over 60 years, Virginia Hospital Center has provided exceptional medical services to the Washington metropolitan area. In November of 2004, Virginia Hospital Center celebrated the Grand Opening of a new $150 million state-of-the-art facility. Virginia Hospital Center offers comprehensive healthcare and multiple Centers of Excellence including: Cardiology & Cardiovascular Surgery, Oncology, Urology and Women & Infant Health. Growing service lines include Neuroscience and the only Lung Cancer Center in Northern Virginia. Virginia Hospital Center is a teaching hospital, long-associated with Georgetown University's School of Medicine, and accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and Licensed by the Commonwealth of Virginia Department of Health. For additional information, please visit www.virginiahospitalcenter.com .
Asthmatx is developing catheter-based medical devices for the treatment of asthma, a disease that affects over 20 million people in the United States. Asthmatx has developed the Alair(R) System to perform an outpatient procedure called Bronchial Thermoplasty(TM). Bronchial Thermoplasty involves the delivery of precisely controlled thermal energy to the airway wall, to reduce the amount of airway smooth muscle, and lessen these muscles' ability to narrow the airway. The results of three clinical studies of the Alair System suggest the procedure may offer significant benefits to patients with severe asthma.
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