An Outpatient Procedure for Asthma Shows Positive Results
SAN DIEGO--(BUSINESS WIRE)--May 22, 2006--Results of the randomized and controlled Asthma Intervention Research (AIR) Trial, to examine the safety and efficacy of a new catheter-based procedure for the treatment of moderate to severe asthma, were reported today at the annual scientific assembly of the American Thoracic Society (ATS) by Dr. Gerard Cox, Professor of Medicine, McMaster University, Canada, Past President of the Canadian Thoracic Society, and principal investigator of the AIR Trial. The data from this international multicenter study showed that, as compared to a control group, subjects treated with Bronchial Thermoplasty demonstrated significantly greater improvements in key clinical parameters, including peak flow, quality of life and symptom free days.
Bronchial Thermoplasty(TM), an out-patient investigative procedure, uses the Alair® System from Asthmatx, Inc. to deliver thermal energy to the airway walls to reduce the presence of airway smooth muscle, the tissue responsible for airway constriction which can lead to breathing difficulties in asthma patients.
“The earlier feasibility study demonstrated that Bronchial Thermoplasty was well tolerated and demonstrated clinical improvements in patients with mild to moderate asthma. The much larger AIR Trial provides additional evidence that Bronchial Thermoplasty may also benefit patients with more severe asthma,” states Dr. Cox, “There is a great need for more effective treatments for severe asthma where patients often do not respond well to current drug therapies.”
These AIR Trial results follow the recent publication of the earlier clinical work in the May 1st issue of the American Journal of Respiratory and Critical Care Medicine (AJRCCM). Accompanying this publication was an editorial entitled “Hot Stuff” Bronchial Thermoplasty for Asthma, commenting on the potential for Bronchial Thermoplasty to provide a completely new approach for treating more severe asthma. For details on AJRCCM coverage visit http://thoracic.org/sections/publications/press-releases/journal/may- 2006.html
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“We are very encouraged by the results of this large randomized study of 110 patients followed out to one year beyond treatment. These data suggest that Bronchial Thermoplasty provides a durable benefit to patients with moderate to severe asthma,” states Glen French, CEO of Asthmatx. “Later this year, we anticipate announcing positive results from another study of Bronchial Thermoplasty in patients with very severe asthma, and our fourth study, an FDA-approved IDE pivotal study, is already well underway at roughly forty top-tier medical centers around the world.”
Bronchial Thermoplasty is an 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.
About the AIR2 Trial
The fourth clinical study of Bronchial Thermoplasty in asthma patients has begun with the AIR2 Trial (www.AIR2Trial.com) which will enroll approximately 300 patients worldwide this year. Currently, more than 130 patients have already entered the pre-treatment baseline period or have started their treatment course.
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 study. For more information on participation, please call the following toll-free number: (866) 400-AIR2 or visit www.AIR2Trial.com.
NOTE: 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(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 early results of three clinical studies of the Alair System suggest the procedure may offer significant benefits to patients with asthma.
Contact: Asthmatx Karen Passafaro, 650-810-1118 kpassafaro@asthmatx.com
Source: Asthmatx