Penn to Test New Thermal Energy Procedure to Reduce Asthmatic Symptoms.

PHILADELPHIA -- New Procedure May Revolutionize Traditional Asthma Care By Lessoning Smooth Muscle Tissue in the Airway

Up until now, if you suffer from asthma, medication has been the only treatment available to you for relief. But now, clinical researchers at the Hospital of the University of Pennsylvania (HUP) hope to open up a new avenue to alleviate the debilitating symptoms of asthma - through an investigative bronchoscopic procedure where the smooth muscle of the airway, which causes the spasm, is reduced using thermal energy.

"Even though the smooth muscle in your airway serves no identifiable purpose, when something does go wrong with it, it can cause problems," explains Ali Musani, MD, an interventional pulmonologist at Penn and principal investigator of the study. "It can constrict, tighten, and narrow the airway considerably -- causing real health consequences for asthmatics."

Interventional pulmonologists will explore, for the first time in the United States, a new way to treat asthma. Physicians will actually go into the airways with a bronchoscope, which is a routine procedure, and by generating and applying thermal energy, will reduce areas of underlying smooth muscle in the small to medium size airways with a new medical device. The Alair(R) System - which is manufactured by Asthmatx, Inc. - consists of a single-use device and a controller that delivers thermal energy to the bronchial wall during an outpatient bronchoscopic procedure known as Bronchial Thermoplasty(TM).

The system, which has an expandable wire basket at the tip, consists of four arms that come in contact with and fit snugly against the airway wall. The expanded basket then delivers controlled radio frequency energy for about 10 seconds to heat the airway smooth muscle. Once the treatment session is completed, the device and the bronchoscope are removed. The controlled heat is designed to reduce the amount of airway smooth muscle in the airway wall, thus reducing the ability of the airway walls to contract and narrow and spasm in response to irritation, infection or inflammation.

"This is a minimally invasive procedure performed in a Bronchoscopy suite," says Maureen George, PhD, RN, AE-C, Coordinator, Comprehensive Asthma Care Program in the Pulmonary, Allergy and Critical Care Division at HUP. "The procedure itself takes only about an hour to complete and no general anesthesia is used. This is done on an outpatient basis as a bronchoscopic procedure, with conscious sedation (in which a tube is placed through the mouth or nose and positioned into the lungs). There is no incision and no need to stay overnight."

During the clinical trial, physicians will treat one-third of the lungs in each treatment period for three treatment sessions total. Also, patients who are currently highly medicated will stay on their medication for the duration of the study.

In this country, severe asthmatics are a major health problem. It's predicted that 40-50% of adults suffer from asthma leading to lost days at work. Asthma is a common disease in which the airways in the lung become inflamed, excess airway mucus is produced, and airways narrow when muscles within the airway walls contract. Asthma affects more than 20 million people in the U.S.

"There's no expectation that this new procedure will cure asthma but we're hopeful it will be useful in reducing the severity and frequency of asthma symptoms and help to improve the quality of life for asthma sufferers," comments Musani.

Penn researchers have received approval to begin the AIR 2 (Asthma Interventional Research) clinical trial and are now enrolling patients. If you have asthma, are between 18 and 65 years of age, and are a non-smoker, you may be eligible to participate in this study. The Hospital of the University of Pennsylvania is the only site involved in this trial in the state and will eventually be one of 20 sites nationally.

Editor's Notes: To schedule an interview with Drs. Ali Musani or Maureen George, please contact Susanne Hartman at 215-349-5964 or [e-mail].

For more information on the Alair System or Asthmatx, please contact Karen Passafaro at 650-810-1100 x118 or [e-mail].

For questions about enrolling in the trial at Penn, call 1-866-400-AIR2. For more information on the AIR 2 trial, go to: www.AIR2Trial.com

Drs. Ali Musani and Maureen George have no financial interest in Asthmatx. The study is sponsored by Asthmatx.

Diagrams available upon request.

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