Fluticasone propionate in children with moderate asthma.

Abstract

Inhaled corticosteroids are considered to be effective and safe to treat children with asthma. These drugs, often used as maintenance treatment, can, however, influence the HPA-axis, which might be reflected by the serum and urine cortisol concentration. The aim of the present study was to investigate the efficacy and safety of fluticasone propionate (FP) 100 microg administered twice a day via a Diskhaler for 3 mo. FP was tested in a double-blind randomized placebo-controlled parallel 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, symptoms and peak flow recordings (PEFR) were noted in a diary. At each visit lung function was measured, and serum and urinary cortisol were determined. During treatment, wheezing decreased and PEFR values increased in the FP group. FEV1 and PC20-histamine increased and the reversibility decreased in the FP group. All changes were significant, with the exception of the change in nocturnal PEFR. Four weeks after cessation of FP all parameters returned to pretreatment values. Serum cortisol did not change significantly in either treatment group. The decrease in urinary cortisol in the FP group was significant only if it was compared with the increase in urinary cortisol in the placebo group. We conclude that FP 100 microg given twice a day is effective in children with moderate stable asthma. Suppression of the HPA-axis by FP 100 microg given twice daily, although not likely, cannot be ruled out by this study since the absence of a significant decrease in urinary cortisol in the FP group could be due to an insufficient number of patients. Additional studies are required to solve this problem.

Fluticasone Propionate, 100 µg bid, Using a Non‐CFC Propellant, HFA 134a, in Asthmatic Children

“…The improvement in mean morning PEF was seen after as early as one week, which is consistent with data from previous studies with daily doses of 100 µg and 200 µg in children with mild asthma (19)(20)(21). The magnitude of improvement was also comparable with other published data in a study using a daily dose of 200 µg of FP in pediatric patients with mild to moderate asthma (21). A statistically significant interaction between morning and evening PEF and patients who were not using spacer devices was observed, which suggested that patients in the FP CFC pMDI group improved more than those in the FP HFA 134a pMDI group.…”

“…This was supported by the data for the secondary efficacy variables, which demonstrated that there were no clinically meaningful differences between the two treatment groups. The improvement in mean morning PEF was seen after as early as one week, which is consistent with data from previous studies with daily doses of 100 µg and 200 µg in children with mild asthma (19)(20)(21). The magnitude of improvement was also comparable with other published data in a study using a daily dose of 200 µg of FP in pediatric patients with mild to moderate asthma (21).…”

Inhaled Corticosteroids and Asthma Control in Children: Assessing Impairment and Risk

“…18,29,[33][34][35][36][37][38][39][40][41][42][43] In young children (Ͻ30 months old), significantly less daytime and nighttime wheezing (P Ͻ .05 and P Ͻ .01, respectively) were reported with BIS versus placebo, but the specific scores and/or between-treatment changes were not provided. 35 A similar population had significant increases in the percentage of days without cough (P ϭ .011) or wheeze (P ϭ .002) when treated with FP.…”

Efficacy and safety of fluticasone propionate hydrofluoroalkane inhalation aerosol in pre–school-age children with asthma: A randomized, double-blind, placebo-controlled study

“…A similar lack of effect of FP on UC excretion was observed in other studies in children. 4,15,[21][22][23][24][25][26][27][28] Specifically, there was no correlation between FP systemic exposure and change in UC from baseline. The FP HFA formulation had safety and tolerability profiles similar to those of placebo in this study.…”

“…FP HFA had no clinically significant systemic effects as measured by 12-hour overnight UC excretion levels in children age 1 to Ͻ 4 years with asthma. 28 We thank Patrice C. Ferriola, PhD for technical assistance in the preparation of the manuscript and Diane Clements for protocol development.…”