The effect of nebulized budesonide treatment in children with mild to moderate exacerbations of asthma.
BACKGROUND
The role of inhaled corticosteroids in the treatment of acute asthma remains a controversial subject.


OBJECTIVE
A randomized, double-blind, placebo-controlled parallel-group clinical trial on the effect of a 5-d course of nebulized budesonide treatment in children with mild to moderate exacerbation of asthma was performed. The need for systemic corticosteroid intervention was evaluated as the primary outcome measure.


RESULTS
Sixty-seven children aged 6 to 15 y were enrolled. During the emergency department phase, they received three nebulizations of either budesonide(1 mg/dose) or placebo, and then in the home phase of the study, they continued their study medications twice a day for another 4 d. Though the level of improvement in the emergency department phase was similar between the groups given either budesonide or placebo treatments (6.8 +/-1.9% vs 4.0+/-1.5%, p = 0.30, respectively), nebulized budesonide caused a trend towards a benefit in terms of the need for systemic corticosteroid intervention (2/33 vs 7/34, p = 0.07), but not in secondary outcome measures.


CONCLUSIONS
Though we show a tendency towards a benefit with nebulized budesonide in children with mild to moderate exacerbations in terms of prevention of progression of the illness, the documented benefit is small and includes, at least, consideration for clinical significance, cost-effectiveness, impracticality and safety.
Sekerel
Bulent E
BE
Hacettepe University Faculty of Medicine, Paediatric Allergy and Asthma Unit, Ankara, Turkey. b_sekerel@yahoo.com
Sackesen
Cansin
C
Tuncer
Ayfer
A
Adalioglu
Gonul
G
D000280:Administration, Inhalation; D001249:Asthma / Q000175:diagnosis* / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D019819:Budesonide / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D011336:Probability; D012008:Recurrence; D012016:Reference Values; D012129:Respiratory Function Tests; D018570:Risk Assessment; D012720:Severity of Illness Index; D016896:Treatment Outcome
D001993:Bronchodilator Agents; D019819:Budesonide