Peoria Pulmonary Associates to Study New Investigational Outpatient Procedure for Asthma

Peoria Pulmonary Associates is set to begin the AIR2 Clinical Trial to study a treatment that may revolutionize traditional asthma care

Peoria, IL, December 1, 2006

Researchers at Peoria Pulmonary Associates today announced the start of the AIR2 (Asthma Interventional Research) international, multi-center clinical trial to explore a new investigational asthma treatment that may significantly change the course of asthma care. The study focuses on an outpatient procedure called Bronchial Thermoplasty. This procedure uses thermal energy to reduce the amount of smooth muscle in the airway that contributes to the constriction during an asthma attack. Early patient data from trials outside the United States suggest it may hold promise for moderate and severe asthmatic patients.

“Currently, if you suffer from asthma, medication is the only treatment available to you for relief. But now, we are looking at this procedure as a whole new avenue to alleviate the challenging symptoms of asthma,” states William Tillis, MD and Principle Investigator of the AIR2 Trial at Peoria Pulmonary Associates. “During Bronchial Thermoplasty, the thermal energy that is applied to the airway reduces the amount of muscle in the airway walls which reduces the ability for it to constrict. Less constriction in the airways may result in reducing the severity and frequency of asthma symptoms.”

Asthma involves 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 muscles — contract.

During Bronchial Thermoplasty, physicians will actually go into the airways with a flexible bronchoscope through the nose or the mouth, which is a routine procedure, and by generating and applying thermal energy with the Alair® System from Asthmatx, reduce areas of underlying smooth muscle in the small to medium size airways. The Alair System consists of a single-use device and a controller that delivers thermal energy to heat the bronchial wall. The controlled heat is designed to reduce the amount of airway smooth muscle in the airway wall, thereby reducing the ability of the airway walls to contract, narrow and spasm in response to irritation, infection, or inflammation.

During the AIR2 clinical trial, physicians will treat one-third of the lungs in each treatment session for a total of three treatment sessions. The procedure is performed in a medical suite, takes about an hour to complete and is followed by post-procedure observations for approximately 4 hours. The procedure will be performed as an outpatient procedure under conscious sedation. Patients will stay on their maintenance asthma medication for the duration of the study.

The researchers 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.

Asthma is one of the most common and costly diseases in the world. It affects more than 20 million people in the United States alone, with an estimated 2 million emergency room visits and 5,000 deaths per year. The prevalence of asthma is on the rise, and although in some patients the disease abates, there is no cure.

The procedure has been used successfully in 16 patients with asthma who were enrolled in a safety trial at two asthma centers in Canada. Two years following their last treatment, the patients on average showed less airway narrowing. All patients surveyed indicated that they would be willing to undergo the Bronchial Thermoplasty procedure again. An additional randomized study of 110 patients with moderate to severe asthma reported that patients treated with Bronchial Thermoplasty experienced significantly greater improvements in key clinical parameters, including peak flow, quality of life and symptom free days.

Dr. Tillis anticipates enrolling up to 20 patients over the next 6 months as part of the 300-patient trial underway at various sites around the world. If you have asthma, are between 18 and 65 years of age, take medication daily to control your asthma, and are a non-smoker, you may be eligible to participate in this study. Those interested in participating may contact call 1-866-400-AIR2 or visit www.AIR2Trial.com.

NOTE: The Alair System is an Investigational device. It is limited by Federal (United States) law to investigational use. To be used by Qualified Investigators only.

Editor’s Notes

To schedule an interview with Dr. Tillis please contact Kerry Howard at
309-672-5682.

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

Dr. Tillis has no financial interest in Asthmatx. The study is sponsored by Asthmatx.

About Peoria Pulmonary Associates

Peoria Pulmonary physicians, board certified in Pulmonary Medicine, has been treating asthma patients in the Peoria area for over twenty five years. PPA is excited to be participating in researching a new approach to asthma treatment. For information about participating in the study please call 1-866-400-AIR2 for contact information.

In the News

This new trial was recently featured in Popular Science's "Best of What's New 2006."

Asthmatx Alair System: A Way to Fry Asthma Attacks