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Asthma Trial Begins At USC; AIR2 Clinical Trial Looks at First-Ever Procedure to Treat Asthma

Posted on: Monday, 8 May 2006, 09:10 CDT

Asthmatx, Inc., a medical device company that has developed a novel procedure for the treatment of asthma, today announced that researchers at the Keck School of Medicine of the University of Southern California have joined more than 30 research centers worldwide in the AIR2 Clinical Trial studying Bronchial Thermoplasty, an investigational out-patient procedure to treat asthma.

"To date, doctors have relied on drugs, such as inhaled steroids, to reduce inflammation in the lungs. But about 30 percent of asthmatics don't respond well to inhaled steroids," says Richard Barbers, MD, professor of clinical medicine at the Keck School of Medicine and principal investigator of the study at USC. "Our research has found that some people stop responding to inhaled steroids because of permanent changes to their airways. The question is, what can we do to help these patients? We are hoping Bronchial Thermoplasty will provide a new treatment option." Barbers says.

Bronchial Thermoplasty(TM), a minimally invasive procedure, uses the Alair System(R) from Asthmatx to deliver heat 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 out-patient 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 and thermal energy is delivered to reduce the ability of treated airways to constrict. The procedure, like many other flexible endoscopy procedures, is done under light anesthesia, and the patient returns home the same day.

USC is the only California site participating in the AIR2 clinical trail.

Approximately 300 patients will be enrolled worldwide in the study during the coming year. Currently, more than 100 patients have already entered the pre-treatment baseline period or have started their treatment course. The procedure is completed in three bronchoscopic sessions, each lasting less than one hour, and each spaced apart by about three weeks.

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 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 this 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(R) 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.

Source: Business Wire

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