Repeated dose inhaled budesonide versus placebo in the treatment of croup.
OBJECTIVE
To investigate the efficacy and tolerance of 12-hourly dosing with 2 mg 4 mL-1 of inhaled budesonide versus placebo in patients admitted to hospital with moderate/severe croup.


METHODS
Eighty-two children hospitalised with croup received either 2 mg 4 mL-1 of budesonide or placebo 12 hourly (maximum four doses) via Ventstream nebuliser in a randomised, double-blind manner. Croup scores were performed at 0, 2, 6, 12, 24, 36 and 48 h from initial nebulisation whilst the patient remained hospitalised. Follow-up assessments were made 1 and 3 days after discharge.


RESULTS
Improvement was observed in the budesonide group over the 12-h dosing interval when compared to placebo (P = 0.04). Time to attain a significant clinical improvement was superior in the budesonide group (P = 0.01). Three days after discharge seven of 32 placebo-treated patients and one of 34 budesonide-treated patients had sought further medical follow-up (P = 0.02).


CONCLUSIONS
Twelve-hourly dosing with inhaled budesonide significantly improved symptoms of croup as well as decreased relapse rates when compared with placebo.
Roberts
G W
GW
Pharmacy Department, Repatriation General Hospital, Daw Park, South Australia. srobegw@rgh.sa.gov.au
Master
V V
VV
Staugas
R E
RE
Raftos
J V
JV
Parsons
D W
DW
Coulthard
K P
KP
Martin
A J
AJ
D000280:Administration, Inhalation; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D019819:Budesonide / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D002648:Child; D002675:Child, Preschool; D003440:Croup / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D008297:Male; D012016:Reference Values; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D019819:Budesonide