PURPOSE OF THE STUDY.
To compare the efficacy of daily low-dose inhaled glucocorticoids versus intermittent high-dose inhaled glucocorticoids in children at risk for asthma exacerbations.
Children (n = 278) in the study were between the ages of 12 and 53 months with positive values on the modified asthma predictive index (API), recurrent wheezing episodes, and at least 1 exacerbation in the previous year, but a low degree of impairment. Children were excluded from the study if they had received more than 6 courses of oral glucocorticoids or had been hospitalized more than 2 times for wheezing during the previous year.
The subjects were randomly assigned to receive budesonide inhalation suspension for 1 year as either an intermittent high-dose regimen (1 mg twice daily for 7 days, starting early during a predefined respiratory tract illness) or a daily low-dose regimen (0.5 mg nightly) with corresponding placebos. The primary outcome measure was the frequency of exacerbations requiring oral glucocorticoids.
The daily regimen of budesonide did not differ significantly from the intermittent regimen with respect to the frequency of exacerbations, with a rate per patient-year for the daily regimen of 0.97 versus a rate of 0.95 for the intermittent regimen. There were also no significant differences between the groups in other measures, including the time to the first exacerbation, quality of life, and adverse events; however, the mean exposure to budesonide was 104 mg less with the intermittent regimen than with the daily regimen.
A daily low-dose regimen of budesonide was not superior to an intermittent high-dose regimen in reducing asthma exacerbations. Daily administration led to greater exposure to the drug at 1 year.
This well-designed and interesting study will help to change how we treat asthma in children; however, it is important to understand that these results are applicable only to children who fulfill the strictly defined criteria of this trial. For example, these results do not apply to children whose asthma is more severe or children who do not have positive values on the API. Another important consideration is that the intermittent regimen used in this trial (with the secondary result of reduced exposure to budesonide) involved treating with high-dose budesonide only at the onset of predefined respiratory tract illnesses on the basis of individualized symptoms that historically had occurred before the onset of wheezing. This reduced the exposure to budesonide to once every 3.5 months on average, in contrast to the approximately monthly exposure that would be anticipated to be required when such therapy would be started indiscriminately with each upper respiratory tract infection. This approach demands careful, individualized instruction. With these caveats taken into account, physicians may have 2 reasonable approaches to treatment to consider in treating this group of pediatric patients.
- Copyright © 2012 by the American Academy of Pediatrics