TY - JOUR
T1 - Daily or intermittent budesonide in preschool children with recurrent wheezing
AU - Zeiger, Robert S.
AU - Mauger, David
AU - Bacharier, Leonard B.
AU - Guilbert, Theresa W.
AU - Martinez, Fernando D.
AU - Lemanske, Robert F.
AU - Strunk, Robert C.
AU - Covar, Ronina
AU - Szefler, Stanley J.
AU - Boehmer, Susan
AU - Jackson, Daniel J.
AU - Sorkness, Christine A.
AU - Gern, James E.
AU - Kelly, H. William
AU - Friedman, Noah J.
AU - Mellon, Michael H.
AU - Schatz, Michael
AU - Morgan, Wayne J.
AU - Chinchilli, Vernon M.
AU - Raissy, Hengameh H.
AU - Bade, Elizabeth
AU - Malka-Rais, Jonathan
AU - Beigelman, Avraham
AU - Taussig, Lynn M.
PY - 2011/11/24
Y1 - 2011/11/24
N2 - Background: 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. We compared daily therapy with intermittent therapy. Methods: We studied 278 children between the ages of 12 and 53 months who had positive values on the modified API, recurrent wheezing episodes, and at least one exacerbation in the previous year but a low degree of impairment. Children were randomly assigned 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. Results: 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 (95% CI, 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). There were also no significant between-group differences in several other measures of asthma severity, including the time to the first exacerbation, or adverse events. The mean exposure to budesonide was 104 mg less with the intermittent regimen than with the daily regimen. Conclusions: A daily low-dose regimen of budesonide was not superior to an intermittent highdose regimen in reducing asthma exacerbations. Daily administration led to greater exposure to the drug at 1 year. (Funded by the National Heart, Lung, and Blood Institute and others; MIST ClinicalTrials.gov number, NCT00675584.)
AB - Background: 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. We compared daily therapy with intermittent therapy. Methods: We studied 278 children between the ages of 12 and 53 months who had positive values on the modified API, recurrent wheezing episodes, and at least one exacerbation in the previous year but a low degree of impairment. Children were randomly assigned 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. Results: 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 (95% CI, 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). There were also no significant between-group differences in several other measures of asthma severity, including the time to the first exacerbation, or adverse events. The mean exposure to budesonide was 104 mg less with the intermittent regimen than with the daily regimen. Conclusions: A daily low-dose regimen of budesonide was not superior to an intermittent highdose regimen in reducing asthma exacerbations. Daily administration led to greater exposure to the drug at 1 year. (Funded by the National Heart, Lung, and Blood Institute and others; MIST ClinicalTrials.gov number, NCT00675584.)
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U2 - 10.1056/NEJMoa1104647
DO - 10.1056/NEJMoa1104647
M3 - Article
C2 - 22111718
AN - SCOPUS:81855169553
SN - 0028-4793
VL - 365
SP - 1990
EP - 2001
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 21
ER -