Daily or intermittent budesonide in preschool children with recurrent wheezing

Robert S. Zeiger, David Mauger, Leonard B. Bacharier, Theresa W. Guilbert, Fernando 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. RaissyElizabeth Bade, Jonathan Malka-Rais, Avraham Beigelman, Lynn M. Taussig

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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 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.)

Original languageEnglish (US)
Pages (from-to)1990-2001
Number of pages12
JournalNew England Journal of Medicine
Volume365
Issue number21
StatePublished - Nov 24 2011

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Budesonide
Respiratory Sounds
Preschool Children
Asthma
Confidence Intervals
Glucocorticoids
National Heart, Lung, and Blood Institute (U.S.)
Respiratory System
Inhalation
Suspensions
Therapeutics
Placebos
Growth
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Zeiger, R. S., Mauger, D., Bacharier, L. B., Guilbert, T. W., Martinez, F., Lemanske, R. F., ... Taussig, L. M. (2011). Daily or intermittent budesonide in preschool children with recurrent wheezing. New England Journal of Medicine, 365(21), 1990-2001.

Daily or intermittent budesonide in preschool children with recurrent wheezing. / Zeiger, Robert S.; Mauger, David; Bacharier, Leonard B.; Guilbert, Theresa W.; Martinez, Fernando; Lemanske, Robert F.; Strunk, Robert C.; Covar, Ronina; Szefler, Stanley J.; Boehmer, Susan; Jackson, Daniel J.; Sorkness, Christine A.; Gern, James E.; Kelly, H. William; Friedman, Noah J.; Mellon, Michael H.; Schatz, Michael; Morgan, Wayne J; Chinchilli, Vernon M.; Raissy, Hengameh H.; Bade, Elizabeth; Malka-Rais, Jonathan; Beigelman, Avraham; Taussig, Lynn M.

In: New England Journal of Medicine, Vol. 365, No. 21, 24.11.2011, p. 1990-2001.

Research output: Contribution to journalArticle

Zeiger, RS, Mauger, D, Bacharier, LB, Guilbert, TW, Martinez, F, Lemanske, RF, Strunk, RC, Covar, R, Szefler, SJ, Boehmer, S, Jackson, DJ, Sorkness, CA, Gern, JE, Kelly, HW, Friedman, NJ, Mellon, MH, Schatz, M, Morgan, WJ, Chinchilli, VM, Raissy, HH, Bade, E, Malka-Rais, J, Beigelman, A & Taussig, LM 2011, 'Daily or intermittent budesonide in preschool children with recurrent wheezing', New England Journal of Medicine, vol. 365, no. 21, pp. 1990-2001.
Zeiger RS, Mauger D, Bacharier LB, Guilbert TW, Martinez F, Lemanske RF et al. Daily or intermittent budesonide in preschool children with recurrent wheezing. New England Journal of Medicine. 2011 Nov 24;365(21):1990-2001.
Zeiger, Robert S. ; Mauger, David ; Bacharier, Leonard B. ; Guilbert, Theresa W. ; Martinez, Fernando ; Lemanske, Robert F. ; Strunk, Robert C. ; Covar, Ronina ; Szefler, Stanley J. ; Boehmer, Susan ; Jackson, Daniel J. ; Sorkness, Christine A. ; Gern, James E. ; Kelly, H. William ; Friedman, Noah J. ; Mellon, Michael H. ; Schatz, Michael ; Morgan, Wayne J ; Chinchilli, Vernon M. ; Raissy, Hengameh H. ; Bade, Elizabeth ; Malka-Rais, Jonathan ; Beigelman, Avraham ; Taussig, Lynn M. / Daily or intermittent budesonide in preschool children with recurrent wheezing. In: New England Journal of Medicine. 2011 ; Vol. 365, No. 21. pp. 1990-2001.
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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 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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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

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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