A 5- versus 3-day course of oral corticosteroids for children with asthma exacerbations who are not hospitalised: a randomised controlled trial.
OBJECTIVE
To determine whether a 5-day course of oral prednisolone is superior to a 3-day course in reducing the 2-week morbidity of children with asthma exacerbations who are not hospitalised.


METHODS
Double-blind randomised controlled trial of asthma outcomes following a 5-day course of oral prednisolone (1 mg/kg) compared with a 3-day course of prednisolone plus placebo for 2 days. Participants were children aged 2-15 years who presented to the emergency departments of three Queensland hospitals between March 2004 and February 2007 with an acute exacerbation of asthma, but were not hospitalised. Sample size was defined a priori for a study power of 90%.


METHODS
Difference in proportion of children who were symptom-free at Day 7, as measured by intention-to-treat (ITT) and per-protocol analysis; quality of life (QOL) on Days 7 and 14.


RESULTS
201 children were enrolled, and there was an 82% completion rate. There was no difference between groups in the proportion of children who were symptom-free (observed difference, 0.04 [95% CI, - 0.09 to 0.18] by ITT analysis; 0.04 [95% CI, - 0.17 to 0.09] by per-protocol analysis). There was also no difference between groups in QOL (P = 0.42). The difference between groups for the primary outcome was within the equivalence range calculated post priori.


CONCLUSIONS
A 5-day course of oral prednisolone confers no advantage over a 3-day course for children with asthma exacerbations who are not hospitalised.


BACKGROUND
Australian Clinical Trials Registry ACTRN012605000305628.
Chang
Anne B
AB
Royal Children's Hospital, Brisbane, QLD, Australia. annechang@ausdoctors.net
Clark
Ronald
R
Sloots
Theo P
TP
Stone
David G
DG
Petsky
Helen L
HL
Thearle
Donna
D
Champion
Anita A
AA
Wheeler
Coralie
C
Acworth
Jason P
JP
D000284:Administration, Oral; D000293:Adolescent; D001249:Asthma / Q000150:complications / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage*; D006760:Hospitalization; D006801:Humans; D008297:Male; D011239:Prednisolone / Q000008:administration & dosage*; D011788:Quality of Life; D016896:Treatment Outcome
D005938:Glucocorticoids; D011239:Prednisolone