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Study of New Investigational Outpatient Procedure for Asthma Underway at Brigham and Women's Hospital

Posted on: Wednesday, 22 February 2006, 12:01 CST

Researchers at Brigham and Women's Hospital (BWH) have begun an international, multi-center clinical trial to explore a new investigational asthma treatment that may change the course of asthma care. The AIR2 (Asthma Interventional Research) study focuses on a procedure called Bronchial Thermoplasty(tm) to treat severe asthma. The innovative procedure is being researched at BWH and other institutions in the U.S., Canada, Brazil, Australia and the U.K. This procedure is still under clinical investigation, but early patient data suggest it may hold some 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. 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, if one suffers 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 procedure that may reduce 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 walls in an effort to reduce the presence of airway smooth muscle, and thereby reduce the ability of treated airways to constrict.

The Alair System - 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.

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 4 hours. The procedure will be as an outpatient procedure performed under conscious sedation. No general anesthesia is used, no incision is necessary, and there is no need to stay overnight. Also, patients who are currently highly medicated will stay on their medication for the duration of the study.

Michael Wechsler, MD, an interventional pulmonologist at BWH and principal investigator of the study, notes, "During the procedure, thermal energy is applied to the airway in order to reduce the amount of smooth muscle in the airway walls. Reducing this muscle will reduce the airways ability to constrict which in turn may reduce the severity and frequency of asthma symptoms. Since medication is currently the only treatment option for asthma sufferers, this procedure could significantly impact how we manage asthmatic patients in the future."

"The smooth muscle in one's airway is believed to be a vestigial organ, like an appendix. It serves no identifiable purpose, but can cause real problems for asthma patients," explains Elliot Israel, MD, director of Respiratory Therapy and Pulmonary Clinical Research at BWH and a co-investigator in the study. "It can constrict, tighten, and narrow the airway considerable - causing wheezing and breathing troubles on a regular basis."

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(tm) may become one of the many treatments that are available for the management of asthma.

Wechsler anticipates enrolling up to 20 patients over the next year at BWH as part of the 300 patient trial being conducted at various sites around the world. 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 in this study please call 617-732-8260 or 866-400-AIR2.

About the Alair System

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.

To schedule an interview with Dr. Wechsler, please contact Kevin Myron in Brigham and Women's Department of Public Affairs at 617-534-1605

For more information on the Alair System or Asthmatx, please contact Karen Passafaro at 650-810-1100 x118 or kpassafaro@asthmatx.com mailto: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 http://www.air2trial.com/

Dr. Wechsler has no financial interest in Asthmatx. The study is sponsored by Asthmatx, Inc.

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).

About Brigham and Women's Hospital (BWH)

Brigham and Women's Hospital is a 747-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare System, an integrated health care delivery network. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832 and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives, dedication to educating and training health care professionals, and strength in biomedical research. With $370M in funding and more than 500 research scientists, BWH is an acclaimed leader in clinical, basic and epidemiological investigation - including the landmark Nurses Health Study, Physicians Health Studies, and the Women's Health Initiative. For more information about BWH, please visit: www.brighamandwomens.org http://www.brighamandwomens.org.

Source: Business Wire

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