Healthcare Industry News: Alair System
News Release - September 19, 2006
Positive Patient Reported Outcomes Following Bronchial Thermoplasty for Asthma
Patients Report Satisfaction with the Procedure and Improvements in Quality of LifeMOUNTAIN VIEW, Calif.--(HSMN NewsFeed)--Sept. 19, 2006--Asthmatx, Inc., a medical device company that has developed a catheter-based procedure for the treatment for asthma, today announced the publication of positive results of a patient survey from its initial clinical study of Bronchial Thermoplasty for the treatment of asthma in the Volume 10 issue of the Journal of Outcomes Research (JOR). Clinical benefits of Bronchial Thermoplasty in 16 subjects with asthma, reported in the May 2006 issue of the American Journal of Respiratory and Critical Care Medicine (AJRCCM), motivated an assessment of quality of life changes and patient satisfaction with the procedure. Patients reported an increased ability to carry out activities, increased tolerance to allergens, and increased tolerance for physical exertion. Additionally, all of the patients reported a willingness to undergo the procedure again and to recommend it to others.
Bronchial Thermoplasty, an out-patient investigative procedure, uses the Alair® System from Asthmatx to deliver thermal energy to the airway walls to reduce the presence of airway smooth muscle, the tissue responsible for airway constriction and breathing difficulties in asthma patients.
The 16 patients who took part in the Feasibility Study of Bronchial Thermoplasty at two centers in Canada were given a 13-item questionnaire two months after the last patient completed the 12-month medical follow-up visit. The survey was conducted to assess the quality of life changes and patient satisfaction with the procedure. Patients who underwent the Bronchial Thermoplasty procedure reported improvements in quality of life. Additionally, these patients stated that they would probably/definitely undergo the procedure again, and would recommend it to a friend or family member with asthma.
"According to currently accepted international guidelines, asthma treatment should not only improve clinical status but should enable patients to feel better and function more fully in their day-to-day lives. The survey of the patients in this study was designed to evaluate these subjective measures," states Sandra Wilson, PhD, Adjunct Clinical Professor of Medicine at the Stanford University School of Medicine, and Senior Staff Scientist, and Chair of the Department of Health Services Research at the Palo Alto Medical Foundation Research Institute, and lead author of the publication. "Despite limitations imposed by the study design and small number of patients in this study, the results are suggestive of clinical benefits that are meaningful to patients. It will be important to assess the utility of Bronchial Thermoplasty in patients with more severe asthma, in order to identify the patient population that will benefit most from this therapy."
Patients who completed the survey were part of the Feasibility Study of Bronchial Thermoplasty, which was designed to evaluate the safety of performing Bronchial Thermoplasty in patients with mild to severe asthma by examining its impact on lung function and airway responsiveness over two years. Previous safety data reported earlier this year in the AJRCCM indicated that Bronchial Thermoplasty is well tolerated, and the long-term safety assessment at two years showed no deterioration in respiratory health status.
"These survey results provide a useful early assessment of both the ability of patients to tolerate the procedure and their satisfaction with its outcomes over time. The results of this survey, together with previously reported efficacy and safety outcomes, suggest that Bronchial Thermoplasty may offer long-lasting benefits to patients with asthma," states Glen French, CEO of Asthmatx.
Bronchial Thermoplasty is an investigative out-patient procedure that 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 catheter is delivered into the airways through the working channel of this flexible bronchoscope. The tip of the Alair catheter is expanded to contact the walls of targeted airways. Controlled thermal energy is then delivered to the airway walls, resulting in a reduction of muscles within the airway wall that cause airway narrowing in patients with asthma. Although still under clinical investigation, the data from this study suggest that reducing the amount of airway smooth muscle may reduce the ability of treated airways to constrict or narrow. The procedure, like many other flexible endoscopy procedures, is done under light anesthesia, and the patient returns home the same day.
Asthma is one of the most common and costly diseases in the world. The prevalence of asthma is on the rise, and there is no cure. According to the American Lung Association, more than 20 million Americans have asthma, and about two-thirds of these patients are adults. Managing unstable asthma consumes substantial healthcare resources. In the US each year, asthma attacks result in approximately 10 million unscheduled doctor office visits, 2 million emergency rooms visits, 500,000 hospitalizations, and 5,000 deaths.
Current Bronchial Thermoplasty Research - The AIR2 Trial:
The fourth clinical study of Bronchial Thermoplasty in patients with asthma, the AIR2 Trial (www.AIR2Trial.com), is well under way and will enroll approximately 300 patients worldwide this year.
Researchers are careful to point out that there is no expectation that this new investigational procedure will cure asthma. However, it is hoped that the procedure will prove useful in reducing the severity and frequency of asthma symptoms, and improve pulmonary function and the quality of life of patients with asthma.
If you have asthma, are between 18 and 65 years of age, are a non-smoker, and take medication daily to control your asthma, you may be eligible to participate in the AIR2 Trial. For more information on participation, please call the following toll-free number: (866) 400-AIR2 or visit www.AIR2Trial.com.
CAUTION: Alair® System is an Investigational Device. It is limited by United States law to investigational use. To be used by Qualified Investigators only.
Editor's Notes:
For more information on Asthmatx or the Alair System, please contact Karen Passafaro at 650-810-1118 or kpassafaro@asthmatx.com.
About Asthmatx:
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® System to perform an investigational outpatient procedure called Bronchial Thermoplasty. 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.
Source: Asthmatx
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