"Right now, the recommendation is to reduce a patient's therapy once the asthma is controlled for at least three months. However, no one knows the best method to do that," said Dr. John Mastronarde, director of the Asthma Center at Ohio State's Wexner Medical Center. "From both the physician's and patient's perspective, there is often hesitation to adjust medication when someone is doing well, so we need good data to support these decisions."
Asthma therapy typically includes a combination of inhaled corticosteroids to reduce inflammation and mucus in the lungs, and long-acting beta agonists (LABA) that relax and open the airways. Both medications can cause side effects and, in 2006, the U.S. Food and Drug Administration (FDA) issued a public health advisory to caution about risks associated with using LABAs without inhaled corticosteroids. The FDA recommends LABAs be used for the shortest time needed to control asthma symptoms, and be discontinued if possible.
The study is seeking 450 participants from 18 Asthma Clinical Research Centers across the country. People with moderate asthma who enroll in the study will receive combination therapy with fluticasone/salmeterol (Advair) 250/50 mcg twice a day for eight weeks. Participants who are well-controlled and show no symptoms will then be randomized to one of three study arms for 48 weeks. The first group will step down to combination therapy with a 50 percent reduction in the dose of inhaled corticosteroid, fluticasone/salmeterol 100/50 mcg twice a day. The second group will take fluticasone 250 mcg twice per day, eliminating the long-acting beta agonist, salmeterol. The third group will maintain the original dose.
"A few smaller, shorter studies have shown stepping down the inhaled corticosteroid and maintaining the LABA dose is more effective at controlling asthma and lung function, but we need better evidence," Mastronarde said.
The Centers for Disease Control reports the number of people with asthma has grown 15 percent in the last decade. More than 25 million Americans have asthma, costing the U.S. $56 billion per year.
"Anything we can do to help reduce the medications and, therefore, the side effects and costs associated, will help improve care and quality of life," Mastronarde said.
GlaxoSmithKline is supplying the drug and financial support for the study, in collaboration with the American Lung Association.
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