Long-term inhaled corticosteroids in preschool children at high risk for asthma

Theresa W. Guilbert, Wayne J Morgan, Robert S. Zeiger, David T. Mauger, Susan J. Boehmer, Stanley J. Szefler, Leonard B. Bacharier, Robert F. Lemanske, Robert C. Strunk, David B. Allen, Gordon R. Bloomberg, Gregory Heldt, Marzena Krawiec, Gary Larsen, Andrew H. Liu, Vernon M. Chinchilli, Christine A. Sorkness, Lynn M. Taussig, Fernando Martinez

Research output: Contribution to journalArticle

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Abstract

BACKGROUND: It is unknown whether inhaled corticosteroids can modify the subsequent development of asthma in preschool children at high risk for asthma. METHODS: We randomly assigned 285 participants two or three years of age with a positive asthma predictive index to treatment with fluticasone propionate (at a dose of 88 ìg twice daily) or masked placebo for two years, followed by a one-year period without study medication. The primary outcome was the proportion of episode-free days during the observation year. RESULTS: During the observation year, no significant differences were seen between the two groups in the proportion of episode-free days, the number of exacerbations, or lung function. During the treatment period, as compared with placebo use, use of the inhaled corticosteroid was associated with a greater proportion of episode-free days (P=0.006) and a lower rate of exacerbations (P<0.001) and of supplementary use of controller medication (P<0.001). In the inhaled-corticosteroid group, as compared with the placebo group, the mean increase in height was 1.1 cm less at 24 months (P<0.001), but by the end of the trial, the height increase was 0.7 cm less (P=0.008). During treatment, the inhaled corticosteroid reduced symptoms and exacerbations but slowed growth, albeit temporarily and not progressively. CONCLUSIONS: In preschool children at high risk for asthma, two years of inhaled-corticosteroid therapy did not change the development of asthma symptoms or lung function during a third, treatment-free year. These findings do not provide support for a subsequent disease-modifying effect of inhaled corticosteroids after the treatment is discontinued.

Original languageEnglish (US)
Pages (from-to)1985-1997
Number of pages13
JournalNew England Journal of Medicine
Volume354
Issue number19
StatePublished - May 11 2006

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Preschool Children
Adrenal Cortex Hormones
Asthma
Placebos
Therapeutics
Observation
Lung
Growth

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Guilbert, T. W., Morgan, W. J., Zeiger, R. S., Mauger, D. T., Boehmer, S. J., Szefler, S. J., ... Martinez, F. (2006). Long-term inhaled corticosteroids in preschool children at high risk for asthma. New England Journal of Medicine, 354(19), 1985-1997.

Long-term inhaled corticosteroids in preschool children at high risk for asthma. / Guilbert, Theresa W.; Morgan, Wayne J; Zeiger, Robert S.; Mauger, David T.; Boehmer, Susan J.; Szefler, Stanley J.; Bacharier, Leonard B.; Lemanske, Robert F.; Strunk, Robert C.; Allen, David B.; Bloomberg, Gordon R.; Heldt, Gregory; Krawiec, Marzena; Larsen, Gary; Liu, Andrew H.; Chinchilli, Vernon M.; Sorkness, Christine A.; Taussig, Lynn M.; Martinez, Fernando.

In: New England Journal of Medicine, Vol. 354, No. 19, 11.05.2006, p. 1985-1997.

Research output: Contribution to journalArticle

Guilbert, TW, Morgan, WJ, Zeiger, RS, Mauger, DT, Boehmer, SJ, Szefler, SJ, Bacharier, LB, Lemanske, RF, Strunk, RC, Allen, DB, Bloomberg, GR, Heldt, G, Krawiec, M, Larsen, G, Liu, AH, Chinchilli, VM, Sorkness, CA, Taussig, LM & Martinez, F 2006, 'Long-term inhaled corticosteroids in preschool children at high risk for asthma', New England Journal of Medicine, vol. 354, no. 19, pp. 1985-1997.
Guilbert TW, Morgan WJ, Zeiger RS, Mauger DT, Boehmer SJ, Szefler SJ et al. Long-term inhaled corticosteroids in preschool children at high risk for asthma. New England Journal of Medicine. 2006 May 11;354(19):1985-1997.
Guilbert, Theresa W. ; Morgan, Wayne J ; Zeiger, Robert S. ; Mauger, David T. ; Boehmer, Susan J. ; Szefler, Stanley J. ; Bacharier, Leonard B. ; Lemanske, Robert F. ; Strunk, Robert C. ; Allen, David B. ; Bloomberg, Gordon R. ; Heldt, Gregory ; Krawiec, Marzena ; Larsen, Gary ; Liu, Andrew H. ; Chinchilli, Vernon M. ; Sorkness, Christine A. ; Taussig, Lynn M. ; Martinez, Fernando. / Long-term inhaled corticosteroids in preschool children at high risk for asthma. In: New England Journal of Medicine. 2006 ; Vol. 354, No. 19. pp. 1985-1997.
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AU - Morgan, Wayne J

AU - Zeiger, Robert S.

AU - Mauger, David T.

AU - Boehmer, Susan J.

AU - Szefler, Stanley J.

AU - Bacharier, Leonard B.

AU - Lemanske, Robert F.

AU - Strunk, Robert C.

AU - Allen, David B.

AU - Bloomberg, Gordon R.

AU - Heldt, Gregory

AU - Krawiec, Marzena

AU - Larsen, Gary

AU - Liu, Andrew H.

AU - Chinchilli, Vernon M.

AU - Sorkness, Christine A.

AU - Taussig, Lynn M.

AU - Martinez, Fernando

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N2 - BACKGROUND: It is unknown whether inhaled corticosteroids can modify the subsequent development of asthma in preschool children at high risk for asthma. METHODS: We randomly assigned 285 participants two or three years of age with a positive asthma predictive index to treatment with fluticasone propionate (at a dose of 88 ìg twice daily) or masked placebo for two years, followed by a one-year period without study medication. The primary outcome was the proportion of episode-free days during the observation year. RESULTS: During the observation year, no significant differences were seen between the two groups in the proportion of episode-free days, the number of exacerbations, or lung function. During the treatment period, as compared with placebo use, use of the inhaled corticosteroid was associated with a greater proportion of episode-free days (P=0.006) and a lower rate of exacerbations (P<0.001) and of supplementary use of controller medication (P<0.001). In the inhaled-corticosteroid group, as compared with the placebo group, the mean increase in height was 1.1 cm less at 24 months (P<0.001), but by the end of the trial, the height increase was 0.7 cm less (P=0.008). During treatment, the inhaled corticosteroid reduced symptoms and exacerbations but slowed growth, albeit temporarily and not progressively. CONCLUSIONS: In preschool children at high risk for asthma, two years of inhaled-corticosteroid therapy did not change the development of asthma symptoms or lung function during a third, treatment-free year. These findings do not provide support for a subsequent disease-modifying effect of inhaled corticosteroids after the treatment is discontinued.

AB - BACKGROUND: It is unknown whether inhaled corticosteroids can modify the subsequent development of asthma in preschool children at high risk for asthma. METHODS: We randomly assigned 285 participants two or three years of age with a positive asthma predictive index to treatment with fluticasone propionate (at a dose of 88 ìg twice daily) or masked placebo for two years, followed by a one-year period without study medication. The primary outcome was the proportion of episode-free days during the observation year. RESULTS: During the observation year, no significant differences were seen between the two groups in the proportion of episode-free days, the number of exacerbations, or lung function. During the treatment period, as compared with placebo use, use of the inhaled corticosteroid was associated with a greater proportion of episode-free days (P=0.006) and a lower rate of exacerbations (P<0.001) and of supplementary use of controller medication (P<0.001). In the inhaled-corticosteroid group, as compared with the placebo group, the mean increase in height was 1.1 cm less at 24 months (P<0.001), but by the end of the trial, the height increase was 0.7 cm less (P=0.008). During treatment, the inhaled corticosteroid reduced symptoms and exacerbations but slowed growth, albeit temporarily and not progressively. CONCLUSIONS: In preschool children at high risk for asthma, two years of inhaled-corticosteroid therapy did not change the development of asthma symptoms or lung function during a third, treatment-free year. These findings do not provide support for a subsequent disease-modifying effect of inhaled corticosteroids after the treatment is discontinued.

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