Year: 2011
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: 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 high-dose 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.).
Source: New England Journal of Medicine
Authors: Robert S. Zeiger, David Mauger, Leonard B. Bacharier, Theresa W. Guilbert, Fernando D. Martinez, Robert F. Lemanske, Robert C. Strunk, Ronina Covar, Stanley J. Szefler, Susan Boehmer, Daniel J. Jackson, Christine A. Sorkness, James E. Gern, H. William Kelly, Noah J. Friedman, Michael H. Mellon, Michael Schatz, Wayne J. Morgan, Vernon M. Chinchilli, Hengameh H. Raissy, Elizabeth Bade, Jonathan Malka-Rais, Avraham Beigelman, Lynn M. Taussig
Institutions: Kaiser Permanente, University of California San Diego, Kaiser Permanente San Diego Medical Center, Pennsylvania State University, St. Louis Children's Hospital, Washington University in St. Louis, University of Wisconsin–Madison, University of Arizona, National Heart, Lung, and Blood Institute, National Jewish Health, University of Colorado Anschutz, University of Colorado Denver, University of New Mexico, University of Wisconsin–Milwaukee
Language: English
Subfield: Physiology
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Awards: G1437931143, G1650331929, Colorado Clinical and Translational Science Institute (UL1), G2202404319, G220748524, G2323703909, G246532802, General Clinical Research Center, G3893369592, CARE Network--St. Louis Center, G413336477, Institutional Clinical and Translational Science Award (UW-Madison)(UL1), G4529880844, G475936976, G6413956449, G653564158, G7062379326, Washington University Institute of Clinical and Translational Sciences, G785151132, Washington University Institute of Clinical and Translational Sciences (UL1), Pediatric Asthma Network Data coordinating Center, G85015405, G8862676684, G927165495, Colorado Clinical and Translational Science Institute (UL1)
OpenAlex ID: W2124283091