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Short-term knemometry and urine cortisol excretion in children treated with fluticasone propionate and budesonide: a
1Dept of Paediatrics, Kolding Hospital, Denmark.
Insights
This study compared inhaled corticosteroids budesonide and fluticasone propionate in children. Both drugs showed similar systemic effects, with budesonide at 400 mcg/day significantly reducing growth rate compared to placebo.
Area of Science:
- Pediatric Endocrinology
- Respiratory Medicine
- Pharmacology
Background:
- Systemic effects of inhaled corticosteroids (ICS) in children require thorough comparison.
- Budesonide and fluticasone propionate are commonly prescribed ICS for pediatric respiratory conditions.
Purpose of the Study:
- To compare the short-term effects of budesonide and fluticasone propionate on lower leg growth and adrenal suppression in children.
- To evaluate systemic effects of two different doses (200 mcg/day and 400 mcg/day) of these ICS.
Main Methods:
- Randomized, double-blind, double-dummy, cross-over study involving 48 children (6-12 years).
- Administration of budesonide, fluticasone propionate, or placebo via dry powder inhalers for 2-week periods.
- Measurement of lower leg length by knemometry and 24-hour urinary cortisol excretion.
Main Results:
- At 200 mcg/day, lower leg growth rates were similar for budesonide, fluticasone propionate, and placebo. Fluticasone propionate significantly reduced cortisol excretion compared to placebo, but budesonide did not.
- At 400 mcg/day, no significant difference in growth rate was observed between budesonide and fluticasone propionate. However, budesonide significantly reduced growth rate compared to placebo.
- Both ICS at 400 mcg/day significantly reduced urinary cortisol excretion compared to placebo.
Conclusions:
- Dose-for-dose, budesonide and fluticasone propionate exhibit similar systemic effects in children.
- Higher doses of both ICS can lead to significant adrenal suppression, with budesonide also showing a potential impact on growth velocity at 400 mcg/day.
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 microg x day(-1) of each drug, or placebo. Another 24 children aged 6-12 years received 400 microg x 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 x week(-1)), fluticasone propionate (0.38 mm x week(-1)) or budesonide (0.26 mm x week(-1)). No significant difference (p=0.39) in lower leg growth rate was found between treatment with 400 microg x day(-1) budesonide (0.30 mm x week(-1)) and 400 microg fluticasone propionate treatment (0.37 mm x week(-1)). Growth rate during treatment with budesonide, 400 microg x day(-1), was significantly lower than during placebo treatment (0.52 mm x week(-1)). Cortisol excretion in the urine during treatment with 200 microg x day(-1) fluticasone propionate was significantly reduced as compared with placebo (p=0.006), but not when compared with 200 microg x day(-1) budesonide (p=0.07). Budesonide 200 microg x day(-1) was not significantly different from placebo. Fluticasone propionate and budesonide, both at 400 microg x 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.