Effectiveness of budesonide nebulising suspension compared to disodium cromoglycate in early childhood asthma.
OBJECTIVE
The optimal treatment for early childhood asthma remains controversial. Budesonide (BUD) has shown superiority over placebo in infants, and over disodium cromoglycate (DSCG) in children aged > 2 years. The aim of this double-blind, randomised, parallel-group study was to compare the effectiveness of nebulised BUD and DSCG in asthmatic children aged < 36 months.


METHODS
82 infants (mean age 18.0 months [range, 11.6-31.2 months]) with suspected asthma (three exacerbations of dyspnoea and wheezing during the past 12 months, with one or more exacerbations in the past 3 months) were treated for 3 months with nebulised BUD (Pulmicort Respules) 0.5 mg/2 mL bid or DSCG 20 mg/2 mL tid. Follow-up was at 6 months.


RESULTS
Patients treated with BUD had a lower exacerbation rate than DSCG-treated patients after 3 months of treatment (5.4% vs. 31.7%; p = 0.003) and towards the end of follow-up (30% vs. 49%; p = 0.062). During treatment, days without cough were 80% and 65% for BUD and DSCG, respectively (p = 0.014), and nights without cough were 89% and 78%, respectively (p = 0.016). Side-effects were mild and of similar frequency in both groups.


CONCLUSIONS
Inhaled nebulised BUD was well tolerated and more effective than nebulised DSCG in reducing the incidence of asthma exacerbations and days with symptoms. These beneficial effects of BUD were maintained throughout the 6-month follow-up.
Zielen
S
S
J. W. Goethe-University, Children's Hospital, Frankfurt/Main, Germany.
Rose
M A
MA
Bez
C
C
Jarisch
A
A
Reichenbach
J
J
Hofmann
D
D
D018927:Anti-Asthmatic 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*; D002675:Child, Preschool; D004205:Cromolyn Sodium / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005858:Germany; D006801:Humans; D007223:Infant; D008297:Male; D009330:Nebulizers and Vaporizers; D016896:Treatment Outcome
D018927:Anti-Asthmatic Agents; D001993:Bronchodilator Agents; D019819:Budesonide; D004205:Cromolyn Sodium