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Pulmonary Associates Begins Trial of Asthma Treatment That May Change the Course of Asthma Care

Posted on: Monday, 2 October 2006, 09:00 CDT

Researchers at 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. Conducted at the John C Lincoln North Mountain Hospital the study focuses on a procedure called bronchial thermoplasty. This procedure uses thermal energy to heat the airway and reduces the amount of smooth muscle 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 have moderate to severe asthma, medications are the mainstay of treatment to control and relieve symptoms. , There is the potential this clinical trial may provide an alternative form of treatment that may benefit many asthma sufferers," states Mark Gotfried, MD and principal investigator of the study at Pulmonary Associates. "We are very excited to be part of this trial and currently our research at the John C Lincoln hospital is the only place in the state of Arizona for asthma patients to get access to this procedure." John C. Lincoln Hospital North Mountain was named one of the best hospitals in the country for respiratory care by U.S. News and World Report.

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 use a flexible bronchoscope inserted through the nose or the mouth to deliver thermal energy to the airway walls. The controlled heat is designed to reduce the amount of 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.

"We hope that by reducing constriction in the airways we may reduce the severity and frequency of asthma symptoms for our patients," Gotfried explains.

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 researchers point out that there is no expectation that this procedure will cure asthma. However, it is hoped that it could be useful in reducing the severity and frequency of asthma symptoms and improving quality of life for patients with asthma.

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.

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 an endoscopy 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.

Pulmonary Associates 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.

The study is sponsored by Asthmatx Inc. Dr. Gotfried and his team have no financial interest in Asthmatx.

Source: Business Wire

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