HPA-axis effects of nebulised fluticasone propionate compared with oral prednisolone in childhood asthma.
The aim of this study was to compare the effect of 7 days nebulised fluticasone propionate (FP) with oral prednisolone on 24-h urinary-free cortisol excretion, systemic exposure and safety. This was a randomised, double-blind, double-dummy, two-way crossover study. Thirty-one children (19 male, 12 female, mean age 8 years) with stable asthma were randomly assigned to 7 days treatment with either FP Nebules (2 x 0.5 mg/2 ml bd) or prednisolone tablets once daily (2 mg/kg/day for 4 days [maximum 40 mg] followed by 1 mg/kg/day or half the original dose for 3 days [maximum 20 mg]). After a 2-4 week washout period, patients received the second treatment for 7 days, followed by a 2-week follow-up visit. The primary outcome measure was 24-h urinary-free cortisol concentrations corrected for creatinine. Nebulised FP (1 mg bd) had significantly less effect on 24-h urinary-free cortisol excretion than oral prednisolone (8.9 ng/ml for FP and 5.0 ng/ml for prednisolone, P = 0.001). Systemic exposure to FP was also low. In conclusion, FP Nebules had significantly less effect on hypothalamic-pituitary-adrenal axis function than oral prednisolone in asthmatic children when used at doses recommended for the treatment of an acute exacerbation of asthma.
Price
J
J
Department of Child Health, King's College Hospital, Denmark Hill, London, SE5 9RS, U.K. john.price@kcl.ac.uk
Lenney
W
W
Duncan
C
C
Green
L
L
Flood
Y
Y
Daley-Yates
P
P
Barnacle
H
H
Efthimiou
J
J
D000280:Administration, Inhalation; D000284:Administration, Oral; D000730:Androstadienes / Q000008:administration & dosage*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy* / Q000652:urine; D002648:Child; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D000068298:Fluticasone; D006801:Humans; D006854:Hydrocortisone / Q000652:urine; D007030:Hypothalamo-Hypophyseal System / Q000187:drug effects*; D008297:Male; D010913:Pituitary-Adrenal System / Q000187:drug effects*; D011239:Prednisolone / Q000008:administration & dosage*; D016896:Treatment Outcome
D000730:Androstadienes; D000893:Anti-Inflammatory Agents; D011239:Prednisolone; D000068298:Fluticasone; D006854:Hydrocortisone