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Quintupling Inhaled Glucocorticoids to Prevent Childhood Asthma Exacerbations.

Publication ,  Journal Article
Jackson, DJ; Bacharier, LB; Mauger, DT; Boehmer, S; Beigelman, A; Chmiel, JF; Fitzpatrick, AM; Gaffin, JM; Morgan, WJ; Peters, SP; Sheehan, WJ ...
Published in: N Engl J Med
March 8, 2018

BACKGROUND: Asthma exacerbations occur frequently despite the regular use of asthma-controller therapies, such as inhaled glucocorticoids. Clinicians commonly increase the doses of inhaled glucocorticoids at early signs of loss of asthma control. However, data on the safety and efficacy of this strategy in children are limited. METHODS: We studied 254 children, 5 to 11 years of age, who had mild-to-moderate persistent asthma and had had at least one asthma exacerbation treated with systemic glucocorticoids in the previous year. Children were treated for 48 weeks with maintenance low-dose inhaled glucocorticoids (fluticasone propionate at a dose of 44 μg per inhalation, two inhalations twice daily) and were randomly assigned to either continue the same dose (low-dose group) or use a quintupled dose (high-dose group; fluticasone at a dose of 220 μg per inhalation, two inhalations twice daily) for 7 days at the early signs of loss of asthma control ("yellow zone"). Treatment was provided in a double-blind fashion. The primary outcome was the rate of severe asthma exacerbations treated with systemic glucocorticoids. RESULTS: The rate of severe asthma exacerbations treated with systemic glucocorticoids did not differ significantly between groups (0.48 exacerbations per year in the high-dose group and 0.37 exacerbations per year in the low-dose group; relative rate, 1.3; 95% confidence interval, 0.8 to 2.1; P=0.30). The time to the first exacerbation, the rate of treatment failure, symptom scores, and albuterol use during yellow-zone episodes did not differ significantly between groups. The total glucocorticoid exposure was 16% higher in the high-dose group than in the low-dose group. The difference in linear growth between the high-dose group and the low-dose group was -0.23 cm per year (P=0.06). CONCLUSIONS: In children with mild-to-moderate persistent asthma treated with daily inhaled glucocorticoids, quintupling the dose at the early signs of loss of asthma control did not reduce the rate of severe asthma exacerbations or improve other asthma outcomes and may be associated with diminished linear growth. (Funded by the National Heart, Lung, and Blood Institute; STICS ClinicalTrials.gov number, NCT02066129 .).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

March 8, 2018

Volume

378

Issue

10

Start / End Page

891 / 901

Location

United States

Related Subject Headings

  • Peak Expiratory Flow Rate
  • Male
  • Humans
  • Growth
  • General & Internal Medicine
  • Fluticasone
  • Female
  • Double-Blind Method
  • Dose-Response Relationship, Drug
  • Child, Preschool
 

Citation

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Chicago
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MLA
NLM
Jackson, D. J., Bacharier, L. B., Mauger, D. T., Boehmer, S., Beigelman, A., Chmiel, J. F., … National Heart, Lung, and Blood Institute AsthmaNet, . (2018). Quintupling Inhaled Glucocorticoids to Prevent Childhood Asthma Exacerbations. N Engl J Med, 378(10), 891–901. https://doi.org/10.1056/NEJMoa1710988
Jackson, Daniel J., Leonard B. Bacharier, David T. Mauger, Susan Boehmer, Avraham Beigelman, James F. Chmiel, Anne M. Fitzpatrick, et al. “Quintupling Inhaled Glucocorticoids to Prevent Childhood Asthma Exacerbations.N Engl J Med 378, no. 10 (March 8, 2018): 891–901. https://doi.org/10.1056/NEJMoa1710988.
Jackson DJ, Bacharier LB, Mauger DT, Boehmer S, Beigelman A, Chmiel JF, et al. Quintupling Inhaled Glucocorticoids to Prevent Childhood Asthma Exacerbations. N Engl J Med. 2018 Mar 8;378(10):891–901.
Jackson, Daniel J., et al. “Quintupling Inhaled Glucocorticoids to Prevent Childhood Asthma Exacerbations.N Engl J Med, vol. 378, no. 10, Mar. 2018, pp. 891–901. Pubmed, doi:10.1056/NEJMoa1710988.
Jackson DJ, Bacharier LB, Mauger DT, Boehmer S, Beigelman A, Chmiel JF, Fitzpatrick AM, Gaffin JM, Morgan WJ, Peters SP, Phipatanakul W, Sheehan WJ, Cabana MD, Holguin F, Martinez FD, Pongracic JA, Baxi SN, Benson M, Blake K, Covar R, Gentile DA, Israel E, Krishnan JA, Kumar HV, Lang JE, Lazarus SC, Lima JJ, Long D, Ly N, Marbin J, Moy JN, Myers RE, Olin JT, Raissy HH, Robison RG, Ross K, Sorkness CA, Lemanske RF, National Heart, Lung, and Blood Institute AsthmaNet. Quintupling Inhaled Glucocorticoids to Prevent Childhood Asthma Exacerbations. N Engl J Med. 2018 Mar 8;378(10):891–901.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

March 8, 2018

Volume

378

Issue

10

Start / End Page

891 / 901

Location

United States

Related Subject Headings

  • Peak Expiratory Flow Rate
  • Male
  • Humans
  • Growth
  • General & Internal Medicine
  • Fluticasone
  • Female
  • Double-Blind Method
  • Dose-Response Relationship, Drug
  • Child, Preschool