FLUTICASONE PROPIONATE IN CHILDREN WITH MODERATE ASTHMA

Inhaled corticosteroids are considered to be effective and safe to tre at children with asthma. These drugs, often used as maintenance treatm ent, can, however, influence the HPA-axis, which might be reflected by the serum and urine cortisol concentration. The aim of the present st udy was to investigate the efficacy and safety of fluticasone propiona te (FP) 100 mu g administered twice a day via a Diskhaler(R) for 3 mo. FP was tested in a double-blind randomized placebo-controlled paralle l trial in a group of 34 children with moderate asthma who did not use inhaled steroids for at least 4 wk prior to the study. At home, sympt oms and peak flow recordings (PEFR) were noted in a diary. At each vis it lung function was measured, and serum and urinary cortisol were det ermined. During treatment, wheezing decreased and PEFR values increase d in the FP group. FEV(1) and PC20-histamine increased and the reversi bility decreased in the FP group. All changes were significant, with t he exception of the change in nocturnal PEFR. Four weeks after cessati on of FP all parameters returned to pretreatment values. Serum cortiso l did not change significantly in either treatment group. The decrease in urinary cortisol in the FP group was significant only if it was co mpared with the increase in urinary cortisol in the placebo group. We conclude that FP 100 mu g given twice a day is effective in children w ith moderate stable asthma. Suppression of the HPA-axis by FP 100 mu g given twice daily, although not likely, cannot be ruled out by this s tudy since the absence of a significant decrease in urinary cortisol i n the FP group could be due to an insufficient number of patients. Add itional studies are required to solve this problem.