According to a study published in the November 24 issue of the New England Journal of Medicine, intermittent administration of a high dose of inhaled budesonide resulted in no more exacerbations over the course of a year in young children with asthma than daily inhalation of a low dose, and the intermittent regimen resulted in significantly lower budesonide exposure. According to the authors, the study was conducted in response to concerns about effects on children’s growth due to daily inhaled corticosteroid (ICS) therapy.
The study, which involved 278 children between the ages of 12 and 53 months, was a randomized, double-blind, parallel-group trial. The maintenance low dose group inhaled 0.5 mg Pulmicort Respules once daily, and the high dose intermittent group was administered 1.0 mg twice daily for 7 days at the onset of symptoms or an apparent respiratory tract infection.
The researchers found no significant differences in the number of exacerbations, the time to first exacerbation, or adverse events between the two groups. While the daily maintenance group was exposed to approximately 100 mg more budesonide over the course of the year-long study, there were no also no significant differences in height, weight, or head circumference.
In their conclusions, the authors suggest that “the inability to show the superiority of a daily low-dose regimen of budesonide over an intermittent high-dose regimen may be important in the preparation of future guidelines.” They warn, however, that “Although the observed exacerbation rates in the two study groups were numerically similar, our results do not show with certainty that the two treatments were equally effective” due to a wide confidence interval for the relative rate of exacerbations. The possibility exists, they note, “that either treatment could be up to 35% more effective than the other.”
Read the NEJM article.
