Side-effects of fluticasone in asthmatic children: No effects after dose reduction

Abstract

To assess long-term effects and side-effects of fluticasone propionate (FP), a 2-yr study was performed, comparing a step-down dose approach (1,000 μg·day-1, with reductions every 2 months to 500, 200 and 100 μg·day-1 for the remainder of the study) versus a constant dose (200 μg·day-1). In 55 children with chronic persistent asthma, aged 6-10 yrs, airways hyperresponsiveness (AHR) and systemic side-effects (height, bone parameters and adrenal cortical function) were assessed at predetermined intervals in a double-blind prospective 2-yr study. AHR improved after 4 months treatment with 1,000 μg·day-1 FP followed by 500 μg·day-1, without significant differences during long-term treatment between the two approaches. Dose-dependent reduction of growth velocity, adrenal cortical function and biochemical bone turnover was found during therapy with 1,000 and 500 μg·day-1 FP when compared with 200 μg·day-1. In conclusion, doses of 1,000 and 500 μg·day-1 fluticasone propionate are associated with marked reductions of growth velocity, bone turnover and adrenal cortical function. However, conventional doses (≤200 μg·day-1 fluticasone propionate) appear to be safe in the long-term management of childhood asthma. From a safety point of view, high doses of fluticasone propionate should only be prescribed in exceptions, e.g. in persistent severe asthma. © ERS Journals Ltd 2004.