FDA Recommendations May Jeopardize Asthma Control

Many children with asthma lose control of their condition after discontinuing therapy with long-acting beta agonists (LABAs), indicates a small-scale study conducted by researchers at the University of Louisville. The study results, which call into question a 2010 FDA recommendation to stop LABA therapy once a patient’s condition is under control, were presented last month at the annual scientific meeting of the American College of Allergy, Asthma & Immunology in Boston.

The study included 54 asthma patients between the ages of six and 17, all of whom were administered LABAs and inhaled corticosteroids to manage their condition. The researchers discontinued LABA therapy once the patients achieved normal or near normal scores on tests of asthma control, as is recommended by the FDA. Within three months of attaining control, however, 37% of the participants had once again lost control of their asthma. The children who lost asthma control needed further treatment, including with LABAs. Two participants whose condition was particularly severe required administration of systemic steroids.

“LABA therapy is shown to be the best add-on therapy for pediatric patients whose asthma cannot otherwise be controlled,” said lead researcher Adrian O’Hagan, MD, a pediatric pulmonologist at the University of Louisville, in a press release. “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. We believe larger trials are needed to determine whether the FDA’s recommendation should be revisited.”

While research is still underway to discover the most effective method of achieving long-term asthma control, O’Hagan and his colleagues recommend that parents of asthma patients request lung function testing upon diagnosis, have their child strictly adhere to the pediatrician’s treatment plan, and attend all follow-up appointments, as asthma tends to vary with time and treatment plans may require periodic alteration.