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Intermittent high-dose budesonide therapy effective in wheezing pre-school children

Reference: N Engl J Med 2011; 365:1990-2001

Source: N Engl J Med

Date published: 24/11/2011 15:58

Summary
by: Hina Radia

According to a study published in the New England Journal of Medicine, short, as-needed treatment with high-dose inhaled budesonide can control recurrent wheezing in preschool children, with less exposure to corticosteroids than daily low-dose therapy.

 

Daily inhaled glucocorticoids are recommended for young children at risk for asthma exacerbations, as indicated by a positive value on the modified asthma predictive index (API) and an exacerbation in the preceding year, but concern remains about daily adherence and effects on growth. Researchers therefore conducted the Maintenance and Intermittent Inhaled Corticosteroids in Wheezing Toddlers (MIST) trial to determine whether a daily low-dose regimen of budesonide would be superior to an intermittent high-dose regimen in young children who had positive values on the modified API, along with recurrent wheezing, high-risk asthma (≥1 exacerbation in the previous year), and low impairment (infrequent use of salbutamol and infrequent night awakenings between episodes).

 

The study involved 278 children between the ages of 12 months and 53 months who were randomised to receive a 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 was the frequency of exacerbations requiring oral glucocorticoid therapy.

 

The researchers reported that 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 (95% confidence interval [CI], 0.76 to 1.22) versus a rate of 0.95 (0.75 to 1.20) for the intermittent regimen (relative rate in the intermittent-regimen group, 0.99; 95% CI, 0.71 to 1.35; P=0.60).

 

Additionally, the researchers reported that there were no significant between-group differences in other measures of asthma severity, such as the time to the first exacerbation, or adverse events. Between-group differences in changes in height, weight, and head circumference were not statistically significant. The total exposure to budesonide over the course of the study was less in the intermittent-regimen group (45.7 mg; 95% CI, 38.9 to 52.8) than in the daily-regimen group (149.9 mg; 95% CI, 140.1 to 159.6), with an average reduction of 104 mg (95% CI, -116 to -92) in the intermittent-regimen group.

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