Effectiveness of budesonide nebulising suspension compared to disodium cromoglycate in early childhood asthma

• Published in: Current medical research and opinion Vol. 22; no. 2; pp. 367 - 373
• Main Authors: Zielen, S., Rose, M. A., Bez, C., Jarisch, A., Reichenbach, J., Hofmann, D.
• Format: Journal Article
• Language: English
• Published: England Informa UK Ltd 01.02.2006; Taylor & Francis; Informa Healthcare
• Subjects: Anti-Asthmatic Agents - administration & dosage; Anti-Asthmatic Agents - therapeutic use; Asthma; Asthma - drug therapy; Bronchodilator Agents - administration & dosage; Bronchodilator Agents - therapeutic use; Budesonide - administration & dosage; Budesonide - therapeutic use; Child, Preschool; Cromolyn Sodium - administration & dosage; Cromolyn Sodium - therapeutic use; Disodium cromoglycate; Double-Blind Method; Female; Germany; Growth; Humans; Infant; Male; Nebulised budesonide; Nebulizers and Vaporizers; Preschool children; Treatment Outcome; Germany
• ISSN: 0300-7995; 1473-4877
• DOI: 10.1185/030079906X89739

ABSTRACT 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. Research design and 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. *Pulmicort and Respules are registered trade names of the AstraZeneca group of companies Main outcome measures and 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.