Before removing the black box warning about combining a long-acting beta agonist (LABA) with an inhaled glucocorticoid in the management of asthma, the US Food and Drug Administration (FDA) mandated further safety data. Each of the four companies marketing a LABA for asthma was required to perform a prospective, randomized controlled trial comparing the safety of combination therapy (LABA plus inhaled glucocorticoid) with inhaled glucocorticoid alone in adolescents and adults with asthma.  The investigators concluded that combination therapy with a LABA and glucocorticoid did not result in higher risk for serious asthma-related events, and patients receiving combination therapy had a lower frequency of asthma exacerbations.

These data were a long time coming, and as the study authors point out, are in support of the recent FDA decision to remove the black box warning for combining a LABA with an inhaled glucocorticoid in the management of asthma. And although it wasn’t a primary goal, the individual studies as well as the combined analysis show that combination therapy can be more effective in controlling asthma exacerbations than inhaled steroids alone. Practitioners still need to remember to appropriately counsel patients on the proper use of controllers so that they don’t try to use combination or other controller preparations to excess during exacerbations and instead use the appropriate rescue inhaler.  Please contact your pharmacy for further information on these products and stay tuned for changes to package inserts in the future.