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New Clinical Trial of Investigational Treatment for Asthma Begins at St. Vincent's Hospital Manhattan

Posted on: Wednesday, 29 March 2006, 12:01 CST

Bronchial Thermoplasty is a minimally invasive procedure that may offer an alternative treatment for severe asthma sufferers

Researchers at St. Vincent's Hospital Manhattan today announced its participation in a nationwide clinical trial called the AIR2 Trial. The trial is testing the safety and efficacy of Bronchial Thermoplasty(TM), a minimally invasive investigational procedure that may alleviate the cause of airway constriction that plagues asthma sufferers. The outpatient procedure delivers thermal energy to a patient's airway walls in an effort to reduce airway smooth muscle, a vestigial tissue some call "the appendix of the lungs".

Patients who are candidates for the trial are currently taking high levels of maintenance asthma medications and they will remain on that medication for the duration of the study. During the clinical trial, the research subjects will undergo a total of three bronchoscopic sessions, each lasting about an hour. Subjects receive conscious sedation and no incisions are made. The procedure, like many other flexible endoscopy procedures, is done under light anesthesia, and the participants return home the same day.

While Bronchial Thermoplasty(TM) is still under clinical investigation, the trial will investigate whether the procedure could be useful in reducing the severity and frequency of asthma symptoms, increasing the number of symptom-free days for participants and improving their overall quality of life. There is no expectation that this new investigational procedure will cure asthma.

"Asthma affects thousands of residents in New York City, and millions more across the country and the world," said Dr. Joseph Cicenia, pulmonologist and chief investigator of the AIR 2 Trial at St. Vincent's Hospital Manhattan. "This clinical trial will examine whether Bronchial Thermoplasty could result in a change in asthma treatment and management. For that, St. Vincent's is proud to participate in this landmark trial."

Asthma is one of the most common and costly diseases in the world. According to the New York City Health Department, over 26,000 NYC residents were hospitalized for asthma in 2004, with the highest rates occurring in neighborhoods including Harlem, Central Brooklyn and the South Bronx. Across the United States, asthma affects more than 20 million people, with an estimated 2 million emergency room visits and 6,000 deaths per year attributed to asthma.

Who may be eligible to participate in this trial?

Residents from the New York City metropolitan area, who have been diagnosed with asthma, who are between 18 and 65 years of age, are non-smokers, AND who take medication on a daily basis to control their asthma may be eligible to participate in the AIR 2 (Asthma Interventional Research) trial. For more information on participation in this study please call (866) 400-AIR2 or see www.AIR2Trial.com.

About Saint Vincent's Catholic Medical Centers

Saint Vincent Catholic Medical Centers is one of the New York metropolitan area's most comprehensive health care organizations, serving nearly 600,000 people annually. Saint Vincent's was established in 2000 as a result of the merger of Catholic Medical Centers of Brooklyn and Queens, Saint Vincent's Hospital and Medical Center of New York and Sisters of Charity Healthcare in Staten Island. Sponsored by the Roman Catholic Bishop of Brooklyn and the president of the Sisters of Charity of New York, Saint Vincent's serves as the academic medical center of New York Medical College in New York City.

The system includes six hospitals: Mary Immaculate Hospital, Queens; St. John's Queens Hospital; St. Vincent's Hospital Manhattan; St. Vincent's Hospital Staten Island; Bayley Seton Hospital, Staten Island; and St. Vincent's Hospital Westchester. Resources include over 2,500 physicians, four skilled nursing facilities, a system-wide home care service, a hospice and over 20 ambulatory care sites which provide a broad array of medical, psychiatric and substance abuse services.

In 2005, Saint Vincent's recorded over 82,000 inpatient discharges, more than 1,000,000 outpatient visits, and nearly 650,000 home care visits. Its emergency rooms, which include three Level 1 trauma centers, received 240,000 visits in that same year, while Saint Vincent's is the largest private provider of EMS services in the New York City Fire Department's 9-1-1 service. In 2003, St. Vincent's Midtown (formerly St. Clare's Hospital) became affiliated with the healthcare system.

About Asthmatx

Asthmatx is developing catheter-based medical devices for the treatment of asthma, a disease that affects over 20 million people in the United States. Asthmatx has developed the Alair(R) System to perform an outpatient procedure called Bronchial Thermoplasty(TM), which involves the delivery of precisely controlled thermal energy to the airway wall to reduce the amount of airway smooth muscle, and lessen these muscles' ability to narrow the airway. The results of three clinical studies of the Alair System suggest the procedure may offer significant benefits to patients with severe asthma.

Source: Business Wire

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