UofL Pediatrics study finds FDA recommendation may worsen asthma control


    LOUISVILLE, Ky. – University of Louisville Pediatrics pulmonologist Adrian O’Hagan, M.D., cautioned participants at the American College of Allergy, Asthma & Immunology 2011 Annual Scientific Meeting that stopping children’s long-acting asthma control inhalers once asthma is controlled could cause them to lose control of their asthma again.

    These findings bring into question a U.S. Food and Drug Administration recommendation to limit use of long-acting beta agonists (LABA).

    O’Hagan and his UofL Pediatrics-Pulmonology colleagues Nemr Eid, M.D., and Ronald Morton, M.D., studied 54 patients between 6 and 17 years. All were treated with LABAs and inhaled corticosteroids.

    When the patients achieved normal or near normal scores on tests of asthma control, LABA therapy was discontinued. Within three months of achieving asthma stability, 37 percent of the patients lost asthma control and required additional treatment, including renewed use of LABA. Two of the patients’ exacerbations were severe enough to require systemic steroids, the strongest asthma control medication.

    “LABA therapy is shown to be the best add-on therapy for pediatric patients whose asthma cannot otherwise be controlled. One-third of our patients failed step down therapy, suggesting that we may need to reconsider whether a subset of asthma patients needs long-term LABA therapy,” O’Hagan said. “We believe larger trials are needed to determine whether the FDA’s recommendation should be revisited.”

    The FDA recommended in 2010 that asthma patients being treated with LABAs discontinue therapy when control is achieved because of safety concerns. The National Heart, Lung and Blood Institute 2007 asthma guidelines did not share these concerns.

    While scientists continue to study the best ways to achieve long-term asthma control, O’Hagan, Morton and Eid recommend the following steps for parents of children with asthma: