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University of Wisconsin School of Medicine and Public Health to Study New Investigational Outpatient Procedure for Asthma

Posted on: Monday, 13 March 2006, 12:00 CST

UW School of Medicine and Public Health set to begin the AIR2 Clinical Trial to study a treatment that may revolutionize traditional asthma care

Researchers at University of Wisconsin School of Medicine and Public Health 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 a procedure called Bronchial Thermoplasty(TM) to treat asthma. The innovative procedure is still under clinical investigation, but early patient data suggest it may hold promise for moderate and severe asthmatic patients.

Asthma is one of the most common and costly diseases in the world. It affects more than 20 million people just in the U.S., with an estimated 2 million emergency room visits and 6,000 deaths per year. About nine percent of Wisconsin residents, or 450,000 people, have been diagnosed with asthma. The prevalence of asthma is on the rise, and there is no cure.

Asthma is a disease involving 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 muscle," contract.

Currently, for those who suffer from asthma, medication is the only treatment available for relief. But now, clinical research centers around the globe hope to open up a new avenue to alleviate the challenging symptoms of asthma - through Bronchial Thermoplasty(TM), an investigative, minimally invasive procedure that reduces the amount of airway smooth muscle that is responsible for the constriction of airways in asthma patients.

During Bronchial Thermoplasty,(TM), an outpatient bronchoscopic procedure, physicians will use the Alair(R) System to go into the airways with a flexible bronchoscope through the nose or the mouth and deliver thermal energy to the airway wall, in an effort to reduce the presence of airway smooth muscle and thereby reduce the ability of treated airways to constrict.

During the 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 and takes about an hour to complete, followed by post-procedure observations for approximately four hours. The procedure will be performed as an outpatient procedure, with the patient under conscious sedation. No general anesthesia is used, and no incision is necessary. Also, patients who are currently highly medicated will stay on their medication for the duration of the study.

"The thermal energy that is applied to the airway through this procedure reduces the amount of muscle in the airway walls, decreasing its ability to constrict. Less constriction in the airways may reduce the severity and frequency of asthma symptoms. This could have a significant impact on how we manage asthmatic patients in the future," says Keith C. Meyer, MD, principal investigator of the AIR2 trial at the University of Wisconsin School of Medicine and Public Health.

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. Thus, Bronchial Thermoplasty may become one of the many treatments that are available for the management of asthma.

University of Wisconsin School of Medicine and Public Health study staff anticipate enrolling up to 20 patients over the next year as part of the 300-patient trial being conducted at various sites around the world. Those who have asthma, are between 18 and 65 years of age, and are non-smokers may be eligible to participate in this study. For more information on participation in this stud, please call 866-400-AIR2.

About the Alair System

The Alair System - which is manufactured by Asthmatx, Inc. - consists of a single-use device and a controller that delivers thermal energy to apply heat to the bronchial wall.

The system consists of a catheter with an expandable wire basket at the tip. The four arms of the expanded basket come in contact with and fit snugly against the airway wall. The expanded basket then delivers controlled thermal energy for about 10 seconds to heat the airway smooth muscle. A contiguous series of thermal energy applications are needed to treat along the accessible length of the airways. 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, thereby reducing the ability of the airway walls to contract, narrow and spasm in response to irritation, infection, or inflammation

The Alair System 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 16 patients on average showed less airway narrowing after stimulation with a drug that causes contraction of airway smooth muscle. All patients surveyed indicated that they would be willing to undergo the Bronchial Thermoplasty procedure again, knowing now what the procedure involves. An additional 70 patients with moderate to severe asthma have been treated with this device in subsequent randomized clinical studies conducted outside the US (Canada, Brazil and Europe), and are continuing to be evaluated.

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 Keith C. Meyer, MD, please contact Lisa Brunette at 608-263-5830.

For more information on the Alair System or Asthmatx, please contact Karen Passafaro at 650-810-1100 x118 or kpassafaro@asthmatx.com.

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

Keith C. Meyer, MD has no financial interest in Asthmatx. The study is sponsored by Asthmatx.

(With normal breathing, the airways of the lungs are fully open. For a person with asthma, the airway smooth muscle that circles the airway may become thicker than normal. During an asthmatic attack, in response to an asthma trigger such as an allergen or irritant, the airway smooth muscle may contract leading to airway narrowing and breathing difficulties.)

University of Wisconsin - Asthma Clinical Research Unit

The University of Wisconsin Asthma Clinical Research Unit is a nationally known, world class clinical research facility located in Madison, Wisconsin. Our staff includes a team of physicians with extensive experience in asthma research. On the frontier of clinical research, the unit offers state-of-the-art hospital facilities as well as a team of physicians, pharmacists, nurses and other staff. Affiliated with the prestigious University of Wisconsin School of Medicine and Public Health, the pulmonary research facility is directed by Nizar Jarjour, MD, who has been actively committed to clinical research for more than 12 years.

About Asthmatx

Asthmatx designs, develops and manufactures medical devices for the treatment of asthma, a condition that affects over 20 million people in the United States. Asthmatx has developed the Alair System(R), which consists of a single-use device and a controller that delivers radiofrequency energy during an outpatient bronchoscopic procedure known as Bronchial Thermoplasty. The Alair System provides a novel investigational treatment approach that uses radiofrequency energy to apply controlled heat to the airway wall to reduce the amount of airway smooth muscle and restrict its ability to narrow the airway. Bronchial Thermoplasty has been shown to reduce the narrowing of airway passages in response to bronchoconstrictors, and may potentially improve asthma symptoms in patients with this condition. Asthmatx is currently conducting a pivotal study investigation to establish the safety and efficacy of the Alair System for the treatment of asthma (www.AIR2Trial.com).

Source: Business Wire

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