A critical review of the effects of inhaled corticosteroids on growth.

Inhaled corticosteroids (ICSs) are an effective therapy for the treatment of persistent asthma of all severities because they reduce symptoms, improve lung function, and reduce underlying inflammation. Although ICSs are generally safe for long- term use, there is concern among physicians and patients about potential systemic side effects, including growth inhibition in children. This continued concern of systemic side effects may negatively affect the compliance to ICS treatment. Based on the current guidance to industry from the Food and Drug Administration (FDA), some efficacy and safety studies on ICSs performed in the 1990s had limitations in their design to evaluate the effect of ICS therapy on growth as a safety end point. A review of studies performed with currently available ICSs and their level of conformance with the FDA guidance are presented in this article. The 1-year studies show a small, dose-dependent effect of most ICSs on childhood growth, with some differences across various ICS molecules and across individual children. Some ICSs at the doses studied did not affect childhood growth using rigorous study designs. Most studies did not conform completely with the FDA guidance. The data on effects of childhood ICS use on final adult height are conflicting, but one recent well-designed study showed an effect, clearly warranting additional studies.