Randomized, controlled trial of inhaled budesonide as an adjunct to oral prednisone in acute asthma.
OBJECTIVE
To compare the clinical effect of nebulized budesonide with placebo in acute pediatric asthma.


METHODS
A randomized, controlled, double-blind trial with parallel design was used in the ED of a tertiary care children's hospital. Children aged 6 months to 18 years with a moderate to severe exacerbation of asthma [Pulmonary Index Score (PIS) > or = 5 or < or = 11 after a salbutamol nebulization of 0.15 mg/kg] were eligible. All patients received prednisone 1 mg/kg orally and nebulized salbutamol (0.15 mg/kg) every 30 minutes for 3 doses and then every hour for 4 hours. The intervention was 2 mg (4 mL) of nebulized budesonide or 4 mL of nebulized normal saline.


RESULTS
Baseline characteristics were comparable in the budesonide group (n = 24) and in the placebo group (n = 20). There were no significant differences in the primary outcome measure (PIS) between the 2 groups. However, the PIS at 1 hour had a tendency to be lower in the budesonide group (median = 5) as compared with the placebo group (median = 6; p = 0.07). Survival analysis of release/discharge from the ED/hospital showed a more rapid rate in the budesonide group as compared with the placebo group (p = 0.02). No adverse effects were seen.


CONCLUSIONS
Although these preliminary results suggest that nebulized budesonide may be an effective adjunct to oral prednisone in the management of moderate to severe asthma exacerbations, a larger trial will be required before the widespread use of inhaled budesonide in acute asthma can be advocated.
Sung
L
L
Department of Pediatrics, University of Ottawa, Ontario, Canada.
Osmond
M H
MH
Klassen
T P
TP
D000208:Acute Disease; D000280:Administration, Inhalation; D000284:Administration, Oral; D000293:Adolescent; D000420:Albuterol / Q000008:administration & dosage / Q000627:therapeutic use; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D019819:Budesonide / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004630:Emergencies; D005260:Female; D006760:Hospitalization; D006801:Humans; D007223:Infant; D008297:Male; D009330:Nebulizers and Vaporizers; D011241:Prednisone / Q000008:administration & dosage / Q000627:therapeutic use; D012129:Respiratory Function Tests
D000893:Anti-Inflammatory Agents; D001993:Bronchodilator Agents; D019819:Budesonide; D000420:Albuterol; D011241:Prednisone