NIH study focuses on safe step-down therapy for asthma

Researchers at The Ohio State University Wexner Medical Center are one of 18 clinical research centers taking part in a national study to establish guidelines for safely stepping down treatment in patients whose asthma is well controlled.

“We believe once a patient with asthma is controlled on a certain medication regimen, most physicians and patients with asthma are reluctant to wean off any medication for fear of losing control of asthma.  Thus some patients wind up on more medication than they may actually require,” said John Mastronarde, MD, MSc, director of the Asthma Center at Ohio State’s Wexner Medical Center.

Physicians typically prescribe a combination of inhaled corticosteroids to reduce inflammation and mucus in the lungs, and long-acting beta agonists (LABA) to relax and open the airways. Both medications can cause side effects and, in 2006, FDA issued a public health advisory about risks associated with the use of LABAs without inhaled corticosteroids. FDA recommends LABAs be used for the shortest time to control asthma symptoms, and be discontinued if possible.

Once a patient's asthma is controlled, the drug dose should be lowered carefully, to the minimum dose necessary, according to the National Institutes of Health's guidelines for treating asthma.

“Many managed care providers and hospitals are getting more proactive in assisting asthma patients and their providers by providing references such as the NIH Guidelines and monitoring patients use of asthma medication to offer reminders to the patients and providers of potential adjustments in medications that might be considered,” said Dr. Mastronarde. “It is not clear if these practices are effective or improve patient care or not but effective communication about evidence-based guidelines is never a bad thing.”

The study

The 18 participating asthma clinical research centers plan to enroll 450 patients with moderate asthma. Eligible patients will receive combination therapy with fluticasone/salmeterol (Advair, GlaxoSmithKline) 250/50 µg twice a day for eight weeks. Participants who are well controlled and show no symptoms will then be randomized to one of three study groups for 48 weeks. The first group will reduce the combination therapy by using half the dose of inhaled corticosteroid, fluticasone/salmeterol 100/50 mcg twice a day. The second group will take fluticasone 250 µg twice per day, eliminating the long-acting beta agonist, salmeterol. The third group will maintain the original dose.

The Centers for Disease Control and Prevention reports the number of people with asthma has grown 15% in the last decade. More than 25 million Americans have asthma, costing the United States $56 billion per year.

GlaxoSmithKline is supplying the drug and financial support for the study, in collaboration with the American Lung Association.

“Many asthma patients are very likely on combination inhalers, which are expensive, which they may not require for asthma control and no one has tried to wean their medication,” Dr. Mastronarde said. “One reason is there are limited data on the most effective ways to wean asthma medications and that is the primary reason the American Lung Association and NIH are sponsoring this clinical trial.”