Intranasal corticosteroids are well tolerated in older children and adults. These medications do not suppress the hypothalamic-pituitary-adrenal axis function, but it is not known whether they have adverse effects in children younger than four years. In this study, Galant and colleagues evaluated the potential systemic effects of intranasal fluticasone propionate in children two to three years of age.
This randomized, double-blinded, placebo-controlled study recruited children with allergy symptoms. For six weeks, one group received daily fluticasone propionate in a dosage of 200 mcg, and one group received placebo intranasal spray. Baseline and end-of-study 12-hour creatinine-corrected urinary free cortisol levels were compared.
Sixty of 65 enrolled patients completed the study. The mean change from baselines in 12-hour creatinine-corrected urinary free cortisol concentration was equivalent in both groups. The adjusted mean change from baseline value in the fluticasone group was 0.98, and the change was 0.94 in the placebo group. A similar proportion of both groups reported at least one adverse event, with the incidence of specific adverse events being comparable between the two groups. In the opinion of the investigators, the slightly higher occurrence of vomiting and gastric pain in the fluticasone group was unrelated to the medication. One child in the fluticasone group was withdrawn from the study because of epistaxis and nose pain.
Results of this study showed that intranasal corticosteroids had no differential effects on the hypothalamic-pituitary-adrenal axis function in children two to three years of age compared with placebo. There were few adverse events in either group. The findings correspond to similar results in studies performed on older children and adults.