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FDA recommends large-scale studies of long-acting beta-agonists

The FDA has ordered pharmaceutical companies that manufacture long-acting beta-agonists to conduct five clinical trials that would assess these medications when used with inhaled corticosteroids.

These trials will involve about 53,000 patients; four of the trials will be conducted on adults and adolescents, and one trial will be focused on pediatric patients aged 4 to 11 years. The 6-month studies will begin later this year, and the FDA said it expects to have the full results in 2017.

The long-acting beta-agonists that the FDA want studied include: Foradil (Novartis AG), Advair Diskus (GlaxoSmithKline), Dulera (Merck) and Symbicort (AstraZeneca). Advair Diskus will also be the long-acting beta-agonist used in the pediatric trial.

The FDA changed the labeling on these medications last year, after results from three trials linked the use of long-acting beta-agonists with worsening asthma symptoms, hospitalization in children and adults, and death in some patients with asthma.

FDA officials said they are recommending large-scale studies on these medications because these medications are widely used.

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