Short-term knemometry and urine cortisol excretion in children treated with fluticasone propionate and budesonide: A dose response study

Abstract

Few thorough comparisons of the systemic effects of inhaled corticosteroids in children are available. The aim of this study was to compare the effect of budesonide and fluticasone propionate on short-term lower leg growth. Fluticasone propionate, budesonide and placebo were administered for 2 weeks in a randomized, double-blind, double-dummy, cross- over design. Twenty four children aged 6-12 yrs received 200 μg · day-1 of each drug, or placebo. Another 24 children aged 6-12 years received 400 μg · day-1 of each drug, or placebo. Dry powder inhalers were used. Lower leg length was measured by knemometry twice a week during all three treatment periods, and 24 h cortisol excretion in the urine was measured at the end of each period. In the low-dose group, lower leg growth rate was the same during treatment with placebo (0.35 mm · week-1), fluticasone propionate (0.38 mm · week-1) or budesonide (0.26 mm · week-1). No significant difference (p=0.39) in lower leg growth rote was found between treatment with 400 μg · day-1 budesonide (0.30 mm · week-1) and 400 μg fluticasone propionate treatment (0.37 mm · week-1). Growth rate during treatment with budesonide, 400 μg · day-1, was significantly lower than during placebo treatment (0.52 mm · week-1). Cortisol excretion in the urine during treatment with 200 μg · day-1 fluticasone propionate was significantly reduced as compared with placebo (p=0.006), but not when compared with 200 μg · day-1 budesonide (p=0.07). Budesonide 200 μg · day-1 was not significantly different from placebo. Fluticasone propionate and budesonide, both at 400 μg · day-1, resulted in a significant reduction in cortisol excretion in the urine as compared with placebo (p=0.001). It is concluded that, dose-for-dose, budesonide Turbuhaler and fluticasone propionate Diskhaler have similar systemic effects.