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Randomized, controlled trial of inhaled budesonide as an adjunct to oral prednisone in acute asthma
L Sung1, M H Osmond, T P Klassen
1Department of Pediatrics, University of Ottawa, Ontario, Canada.
Insights
Nebulized budesonide showed a trend toward improving asthma scores and significantly sped up discharge in children with acute exacerbations. Further research is needed to confirm its effectiveness as an adjunct therapy.
Area of Science:
- Pediatric Pulmonology
- Emergency Medicine
- Clinical Pharmacology
Background:
- Acute asthma exacerbations are a common reason for pediatric emergency department visits.
- Current management involves bronchodilators and systemic corticosteroids, but adjunctive therapies are explored to improve outcomes.
Purpose of the Study:
- To evaluate the clinical efficacy of nebulized budesonide compared to placebo in children experiencing moderate to severe acute asthma exacerbations.
Main Methods:
- A randomized, double-blind, placebo-controlled trial was conducted in a tertiary care children's hospital.
- Eligible children (6 months-18 years) with moderate to severe asthma received standard care plus either nebulized budesonide or normal saline.
- Standard care included oral prednisone and repeated nebulized salbutamol.
Main Results:
- While the primary outcome (Pulmonary Index Score) did not show a statistically significant difference, there was a trend towards lower scores at 1 hour with budesonide.
- Patients receiving nebulized budesonide demonstrated a significantly faster rate of release/discharge from the emergency department and hospital.
- No adverse effects were reported in either the budesonide or placebo groups.
Conclusions:
- Nebulized budesonide may serve as a beneficial add-on treatment to oral prednisone for moderate to severe pediatric asthma exacerbations.
- Preliminary findings suggest potential for improved clinical outcomes and reduced length of stay.
- Larger clinical trials are warranted to definitively establish the role of inhaled budesonide in acute pediatric asthma management.
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.
Conclusion:
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.