Nebulized budesonide after hospitalization for recurrent bronchial obstruction in children younger than 18 months

A multi-center, double-blind, randomized dose-response study was performed to assess the effect of 3 months of treatment with two different doses of inhaled nebulized budesonide in children with acute recurrent bronchial obstruction (BO) causing hospitalization. Steroid-naive children younger than 18 months were included when admitted to hospital because of BO for at least the second time, and were followed-up monthly for 15 months. Forty-five of 49 subjects (43 boys, 2 girls) (mean age 9.3 months upon inclusion) completed the study. Twenty-four patients (20 boys, 4 girls) received nebulized budesonide 0.5 mg twice daily for 1 month followed by 0.25 mg daily for the next 2 months, whereas 25 children received 0.1 mg twice daily throughout the 3-month treatment period. Outcome (number of BO episodes, time to first BO after start of treatment, and use of rescue medication), as well as height/length and weight, were assessed at the start of treatment and monthly for the following 3 months, as well as for 12 months after cessation of treatment (15 months in total). There was an overall tendency towards better symptom control (fewer episodes of acute BO during treatment and follow-up, fewer hospital visits because of acute BO, lower clinical score during follow-up, and less use of rescue medication during follow-up) in the high-dose treatment group vs. the low-dose treatment group. However, the differences did not reach statistical significance for any of the outcomes. The only significant difference in effect between the groups was fewer children in the high-dose group treated openly with nebulized budesonide during follow-up. Length/height and weight gain did not differ significantly between the two treatment groups throughout the study. There was no significant dose-dependent beneficial effect of 3 months of treatment with nebulized budesonide in infants and toddlers with at least two hospitalizations for acute bronchial obstruction.