Using a new approach, a St. Louis pulmonologist tested a non-pharmaceutical method to treat severe asthma that does not respond to conventional treatment, using heat to relax airway muscles. The minimally invasive outpatient procedure is known as bronchial thermoplasty, which uses controlled radiofrequency-generated heat to treat the muscles of the airways, preventing them from constricting and narrowing.
The study marks the most recent phase of investigational trials of the Alair System, the device used in the bronchial thermoplasty procedure. Alair is manufactured by Asthmatx. If approved, by the Food and Drug Administration, it would become the first non-pharmaceutical therapy to effectively treat severe asthma.
Despite taking high does of asthma medications, people with severe asthma have symptoms continuously – throughout the day and awaken frequently during the night with breathing difficulties.
St. Louis was is number 16 on the 2009 Asthma Capitals in the U.S., based on annual research by the Asthma and Allergy Foundation of America, which examined a combination of factors, including asthma prevalence; risk factors, such as air quality, pollen counts, poverty and smoke free laws; and medical factors, including the use of emergency relief medication, controller medication and the number of asthma specialists in the area.
“We have a lot of problems with allergies here. Last year was one of the highest mold counts that we’ve ever had here in St. Louis,” Dr. Mario Castro, director of the Pulmonary Function Laboratory at The Asthma Center, associate professor of medicine at Washington University School of Medicine and a lead investigator on the Alair study.
In addition to being nestled next to the “Mighty Mississippi” River, factors controlled by elected leaders have a lot to with St. Louis being on such an unhealthy list and efforts thus far to clear the air in St. Louis have gone up in smoke.
“We are not a very friendly place for people who are affected by asthma and lung disease. We have no really public smoke-free places,” Castro said.
Castro is vice president and a board member of the American Lung Association. He said he was behind efforts to increase the tobacco tax and noted that St. Louis also has one of the worst rates of teens smoking.
“There are few places to go freely with relief from bronchial spasms,” Castro said.
“If they are exposed to smoke, it could trigger them to go into asthma attack.”
Asthma has a tight choke hold on the St. Louis African American community.
“We found that if you were African American with asthma, you had an eight-fold higher risk of being hospitalized as compared to non African Americans. Mortality here is about three-fold higher for African Americans as compared to non African Americans,” he said.
The asthma expert has conducted a number of studies relating to asthma in St. Louis and Castro presented his findings on the Alair system on May 18 during the 105th International Conference of the American Thoracic Society in San Diego.
Castro’s research will be submitted to the FDA, and he said it “provides evidence supporting the effectiveness and safety of the Alair system when used in the bronchial thermoplasty procedure.”
About 300 patients in the multi-center study were enrolled from 30 locations in six countries. Eighteen patients came from St. Louis.
“We think this new approach, heating up the bronchial tubes just enough to keep them from twitching will give them lasting relief,” Castro said.
The therapy involves one series of three outpatient bronchoscopy treatments scheduled two weeks apart.
“One part of the lung on the first, the other part on the second and the upper part of the lung on the third,” Castro said. “It does make your asthma a little bit worse for the first week and a half and then we see the benefits.”
Participants were split into two subgroups. Patients in the control group were randomly assigned to receive a placebo or “sham” treatment, meaning that no heat was applied while they underwent the procedure.
A quality-of-life scale measured the results at six months, nine months and at one year. Overall, 79 percent of the patients in the treatment group experienced a statistically significant and clinically meaningful improvement.
“Following a procedure, patients treated with bronchial thermoplasty experience persistent asthma control over the year following treatment, based on improvement in the asthma quality of life, a significant reduction in rates of severe asthma attacks and a reduction of emergency room visits for respiratory symptoms,” Castro said.
One of those patients who achieved success from the treatment is Chantel Hamilton, a 36-year-old St. Louis woman who has had a rough time with asthma.
“I was having asthma attacks whenever the seasons change. I was averaging two hospitalizations a year and I average three asthma attacks a month,” Hamilton said. “Those were the major ones. The minor ones – the tightness of the breath, the tightness of the chest and breathing ‘out my neck,’ I did that on a regular basis. And now I haven’t experienced too much of that at all.”
According to the American Lung Association, more than 20 million Americans have asthma, and asthma attacks result in about ten million unscheduled doctor office visits, two million emergency room visits, and 4,000 deaths annually.
Castro said treating persons with severe asthma accounts for a lot of the cost of asthma health care.
“That’s 15 to 20 percent of people account for 85 percent of health care costs associated with asthma,” Castro estimated.
Castro said the high level of continued commitment from all study participants underscores the need for effective asthma control in patients who suffer from severe forms of the disease.
“Our high compliance rate and the fact that initially over 580 patients consented to participate in a study that included three potential sham bronchoscopy procedures certainly confirmed that this group of severe asthma patients is a very needy population for whom current therapies are inadequate,” Castro noted. “Bronchial thermoplasty addresses an unmet medical need, offering significant advantages over the existing standard of care for patients suffering from severe asthma.”
“I can tell a big difference because now I don’t have as many asthmatic problems as I did before. I’m actually – I would say, 75 percent cured. That’s how good I feel,” Hamilton said gleefully.
For more information on asthma and allergies, go to www.asthma-stlouis.org, www.allergycapitals.com, www.aafa.org or www.lungusa.org.
