Repeated dose inhaled budesonide versus placebo in the treatment of croup

Objective: To investigate the efficacy and tolerance of 12‐hourly dosing with 2 mg 4 mL–1 of inhaled budesonide versus placebo in patients admitted to hospital with moderate/severe croup. Method: Eighty‐two children hospitalised with croup received either 2 mg 4 mL–1 of budesonide or placebo 12 hourly (maximum four doses) via Ventstream® nebuliser in a randomised, double‐blind manner. Croup scores were performed at 0, 2, 6, 12, 24, 36 and 48 h from initial nebulisation whilst the patient remained hospitalised. Follow‐up assessments were made 1 and 3 days after discharge. Results: Improvement was observed in the budesonide group over the 12‐h dosing interval when compared to placebo (P = 0.04). Time to attain a significant clinical improvement was superior in the budesonide group (P = 0.01). Three days after discharge seven of 32 placebo‐treated patients and one of 34 budesonide‐treated patients had sought further medical follow‐up (P = 0.02). Conclusion: Twelve‐hourly dosing with inhaled budesonide significantly improved symptoms of croup as well as decreased relapse rates when compared with placebo.