Budesonide nebulizations on demand results in asthma outcomes identical to those achieved by daily budesonide nebulization in preschool children with less exposure to drug
Summary
This multicenter one-year trial of asthma therapy in children between the ages of 12 and 53 months compared children randomly assigned to receive a budesonide inhalation suspension by intermittent high dose regimen to those receiving a daily low dose regimen.
The high dose regimen was 1 mg twice daily for 7 days started early, during a predefined respiratory tract illness, and the daily low dose regimen consisted of 0.5 mg nightly. There were also corresponding placebos. The primary outcome was the frequency of exacerbations requiring oral glucocorticoid therapy.
There was no difference in the frequency of exacerbations between both of the treatment groups. There was also no significant difference between groups in several other measures including time to first exacerbation or adverse events. However, the cumulative dose of budesonide given during the year was 104 mg less with the intermittent regimen.
The authors concluded that a daily low dose regimen of budesonide was not superior to an intermittent high dose regimen. In addition, the daily administration resulted in a greater exposure to the drug during the year.
Reference
Zeiger RS, et al. Daily or intermittent budesonide in preschool children with recurrent wheezing. New England Journal of Medicine 2011; 365:1990-2001.