Long-term effects of budesonide or nedocromil in children with asthma

James A Tonascia, N Franklin Adkinson, B. Bender, R. Cherniack, M. Donithan, H. W. Kelly, J. Reisman, G. G. Shapiro, Alice L Sternberg, R. Strunk, V. Taggart, Mark L Van Natta, Robert A Wise, M. Wu, R. Zeiger, L. C. Altman, J. W. Becker, C. W. Bierman, T. Chinn, D. Crawford & 78 others T. R. Duhamel, H. Eliassen, C. T. Furukawa, B. Hammond, M. S. Kennedy, M. V. Lasley, D. A. Minotti, C. Reagan, M. Sharpe, F. S. Virant, G. White, T. G. Wighton, P. V. Williams, S. Weiss, S. Babigian, P. Barrant, L. Benson, J. Caicedo, T. Calder, A. DeFilippo, C. Dorsainvil, J. Erickson, P. Fulton, J. Gilbert, M. Grace, D. Greineder, S. Haynes, M. Higham, D. Jakubowski, S. Kelleher, J. Koslof, N. Madden, D. Mandel, A. Martinez, J. McAuliffe, P. Pacella, P. Parks, A. Plunkett, J. Sagarin, K. Seligsohn, M. Syring, M. Tata, W. Torda, J. Traylor, M. Van Horn, C. Wells, A. Whitman, Y. Benedet, S. Carpenter, J. Chay, M. Collinson, J. Finlayson-Kulchin, K. Gore, A. Hall, N. Holmes, S. Klassen, H. Levison, I. MacLusky, M. Miki, J. Quenneville, R. Sananes, C. Wasson, N. Bollers, P. Eggleston, Karen Huss, K. Hyatt, B. Leritz, M. Pessaro, S. Philips, L. Plotnick, M. Pulsifer, Cynthia S Rand, B. Wheeler, S. Szefler, K. Brelsford, J. Bridges, J. Ciacco, R. Covar

Research output: Contribution to journalArticle

Abstract

Background: Antiinflammatory therapies, such as inhaled corticosteroids or nedocromil, are recommended for children with asthma, although there is limited information on their long-term use. Methods: We randomly assigned 1041 children from 5 through 12 years of age with mild-to-moderate asthma to receive 200 μg of budesonide (311 children), 8 mg of nedocromil (312 children), or placebo (418 children) twice daily. We treated the participants for four to six years. All children used albuterol for asthma symptoms. Results: There was no significant difference between either treatment and placebo in the primary outcome, the degree of change in the forced expiratory volume in one second (FEV1, expressed as a percentage of the predicted value) after the administration of a bronchodilator. As compared with the children assigned to placebo, the children assigned to receive budesonide had a significantly smaller decline in the ratio of FEV1 to forced vital capacity (FVC, expressed as a percentage) before the administration of a bronchodilator (decline in FEV1:FVC, 0.2 percent vs. 1.8 percent). The children given budesonide also had lower airway responsiveness to methacholine, fewer hospitalizations (2.5 vs. 4.4 per 100 person-years), fewer urgent visits to a caregiver (12 vs. 22 per 100 person-years), greater reduction in the need for albuterol for symptoms, fewer courses of prednisone, and a smaller percentage of days on which additional asthma medications were needed. As compared with placebo, nedocromil significantly reduced urgent care visits (16 vs. 22 per 100 person-years) and courses of prednisone. The mean increase in height in the budesonide group was 1.1 cm less than in the placebo group (22.7 vs. 23.8 cm, P=0.005); this difference was evident mostly within the first year. The height increase was similar in the nedocromil and placebo groups. Conclusions: In children with mild-to-moderate asthma, neither budesonide nor nedocromil is better than placebo in terms of lung function, but inhaled budesonide improves airway responsiveness and provides better control of asthma than placebo or nedocromil. The side effects of budesonide are limited to a small, transient reduction in growth velocity. (C) 2000, Massachusetts Medical Society.

Original languageEnglish (US)
Pages (from-to)1054-1063
Number of pages10
JournalNew England Journal of Medicine
Volume343
Issue number15
DOIs
StatePublished - Oct 12 2000

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Nedocromil
Budesonide
Asthma
Placebos
Albuterol
Bronchodilator Agents
Prednisone
Methacholine Chloride
Medical Societies
Vital Capacity
Forced Expiratory Volume
Ambulatory Care
Caregivers
Adrenal Cortex Hormones
Hospitalization
Anti-Inflammatory Agents

ASJC Scopus subject areas

  • Medicine(all)

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Long-term effects of budesonide or nedocromil in children with asthma. / Tonascia, James A; Adkinson, N Franklin; Bender, B.; Cherniack, R.; Donithan, M.; Kelly, H. W.; Reisman, J.; Shapiro, G. G.; Sternberg, Alice L; Strunk, R.; Taggart, V.; Van Natta, Mark L; Wise, Robert A; Wu, M.; Zeiger, R.; Altman, L. C.; Becker, J. W.; Bierman, C. W.; Chinn, T.; Crawford, D.; Duhamel, T. R.; Eliassen, H.; Furukawa, C. T.; Hammond, B.; Kennedy, M. S.; Lasley, M. V.; Minotti, D. A.; Reagan, C.; Sharpe, M.; Virant, F. S.; White, G.; Wighton, T. G.; Williams, P. V.; Weiss, S.; Babigian, S.; Barrant, P.; Benson, L.; Caicedo, J.; Calder, T.; DeFilippo, A.; Dorsainvil, C.; Erickson, J.; Fulton, P.; Gilbert, J.; Grace, M.; Greineder, D.; Haynes, S.; Higham, M.; Jakubowski, D.; Kelleher, S.; Koslof, J.; Madden, N.; Mandel, D.; Martinez, A.; McAuliffe, J.; Pacella, P.; Parks, P.; Plunkett, A.; Sagarin, J.; Seligsohn, K.; Syring, M.; Tata, M.; Torda, W.; Traylor, J.; Van Horn, M.; Wells, C.; Whitman, A.; Benedet, Y.; Carpenter, S.; Chay, J.; Collinson, M.; Finlayson-Kulchin, J.; Gore, K.; Hall, A.; Holmes, N.; Klassen, S.; Levison, H.; MacLusky, I.; Miki, M.; Quenneville, J.; Sananes, R.; Wasson, C.; Bollers, N.; Eggleston, P.; Huss, Karen; Hyatt, K.; Leritz, B.; Pessaro, M.; Philips, S.; Plotnick, L.; Pulsifer, M.; Rand, Cynthia S; Wheeler, B.; Szefler, S.; Brelsford, K.; Bridges, J.; Ciacco, J.; Covar, R.

In: New England Journal of Medicine, Vol. 343, No. 15, 12.10.2000, p. 1054-1063.

Research output: Contribution to journalArticle

Tonascia, JA, Adkinson, NF, Bender, B, Cherniack, R, Donithan, M, Kelly, HW, Reisman, J, Shapiro, GG, Sternberg, AL, Strunk, R, Taggart, V, Van Natta, ML, Wise, RA, Wu, M, Zeiger, R, Altman, LC, Becker, JW, Bierman, CW, Chinn, T, Crawford, D, Duhamel, TR, Eliassen, H, Furukawa, CT, Hammond, B, Kennedy, MS, Lasley, MV, Minotti, DA, Reagan, C, Sharpe, M, Virant, FS, White, G, Wighton, TG, Williams, PV, Weiss, S, Babigian, S, Barrant, P, Benson, L, Caicedo, J, Calder, T, DeFilippo, A, Dorsainvil, C, Erickson, J, Fulton, P, Gilbert, J, Grace, M, Greineder, D, Haynes, S, Higham, M, Jakubowski, D, Kelleher, S, Koslof, J, Madden, N, Mandel, D, Martinez, A, McAuliffe, J, Pacella, P, Parks, P, Plunkett, A, Sagarin, J, Seligsohn, K, Syring, M, Tata, M, Torda, W, Traylor, J, Van Horn, M, Wells, C, Whitman, A, Benedet, Y, Carpenter, S, Chay, J, Collinson, M, Finlayson-Kulchin, J, Gore, K, Hall, A, Holmes, N, Klassen, S, Levison, H, MacLusky, I, Miki, M, Quenneville, J, Sananes, R, Wasson, C, Bollers, N, Eggleston, P, Huss, K, Hyatt, K, Leritz, B, Pessaro, M, Philips, S, Plotnick, L, Pulsifer, M, Rand, CS, Wheeler, B, Szefler, S, Brelsford, K, Bridges, J, Ciacco, J & Covar, R 2000, 'Long-term effects of budesonide or nedocromil in children with asthma', New England Journal of Medicine, vol. 343, no. 15, pp. 1054-1063. https://doi.org/10.1056/NEJM200010123431501
Tonascia, James A ; Adkinson, N Franklin ; Bender, B. ; Cherniack, R. ; Donithan, M. ; Kelly, H. W. ; Reisman, J. ; Shapiro, G. G. ; Sternberg, Alice L ; Strunk, R. ; Taggart, V. ; Van Natta, Mark L ; Wise, Robert A ; Wu, M. ; Zeiger, R. ; Altman, L. C. ; Becker, J. W. ; Bierman, C. W. ; Chinn, T. ; Crawford, D. ; Duhamel, T. R. ; Eliassen, H. ; Furukawa, C. T. ; Hammond, B. ; Kennedy, M. S. ; Lasley, M. V. ; Minotti, D. A. ; Reagan, C. ; Sharpe, M. ; Virant, F. S. ; White, G. ; Wighton, T. G. ; Williams, P. V. ; Weiss, S. ; Babigian, S. ; Barrant, P. ; Benson, L. ; Caicedo, J. ; Calder, T. ; DeFilippo, A. ; Dorsainvil, C. ; Erickson, J. ; Fulton, P. ; Gilbert, J. ; Grace, M. ; Greineder, D. ; Haynes, S. ; Higham, M. ; Jakubowski, D. ; Kelleher, S. ; Koslof, J. ; Madden, N. ; Mandel, D. ; Martinez, A. ; McAuliffe, J. ; Pacella, P. ; Parks, P. ; Plunkett, A. ; Sagarin, J. ; Seligsohn, K. ; Syring, M. ; Tata, M. ; Torda, W. ; Traylor, J. ; Van Horn, M. ; Wells, C. ; Whitman, A. ; Benedet, Y. ; Carpenter, S. ; Chay, J. ; Collinson, M. ; Finlayson-Kulchin, J. ; Gore, K. ; Hall, A. ; Holmes, N. ; Klassen, S. ; Levison, H. ; MacLusky, I. ; Miki, M. ; Quenneville, J. ; Sananes, R. ; Wasson, C. ; Bollers, N. ; Eggleston, P. ; Huss, Karen ; Hyatt, K. ; Leritz, B. ; Pessaro, M. ; Philips, S. ; Plotnick, L. ; Pulsifer, M. ; Rand, Cynthia S ; Wheeler, B. ; Szefler, S. ; Brelsford, K. ; Bridges, J. ; Ciacco, J. ; Covar, R. / Long-term effects of budesonide or nedocromil in children with asthma. In: New England Journal of Medicine. 2000 ; Vol. 343, No. 15. pp. 1054-1063.
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abstract = "Background: Antiinflammatory therapies, such as inhaled corticosteroids or nedocromil, are recommended for children with asthma, although there is limited information on their long-term use. Methods: We randomly assigned 1041 children from 5 through 12 years of age with mild-to-moderate asthma to receive 200 μg of budesonide (311 children), 8 mg of nedocromil (312 children), or placebo (418 children) twice daily. We treated the participants for four to six years. All children used albuterol for asthma symptoms. Results: There was no significant difference between either treatment and placebo in the primary outcome, the degree of change in the forced expiratory volume in one second (FEV1, expressed as a percentage of the predicted value) after the administration of a bronchodilator. As compared with the children assigned to placebo, the children assigned to receive budesonide had a significantly smaller decline in the ratio of FEV1 to forced vital capacity (FVC, expressed as a percentage) before the administration of a bronchodilator (decline in FEV1:FVC, 0.2 percent vs. 1.8 percent). The children given budesonide also had lower airway responsiveness to methacholine, fewer hospitalizations (2.5 vs. 4.4 per 100 person-years), fewer urgent visits to a caregiver (12 vs. 22 per 100 person-years), greater reduction in the need for albuterol for symptoms, fewer courses of prednisone, and a smaller percentage of days on which additional asthma medications were needed. As compared with placebo, nedocromil significantly reduced urgent care visits (16 vs. 22 per 100 person-years) and courses of prednisone. The mean increase in height in the budesonide group was 1.1 cm less than in the placebo group (22.7 vs. 23.8 cm, P=0.005); this difference was evident mostly within the first year. The height increase was similar in the nedocromil and placebo groups. Conclusions: In children with mild-to-moderate asthma, neither budesonide nor nedocromil is better than placebo in terms of lung function, but inhaled budesonide improves airway responsiveness and provides better control of asthma than placebo or nedocromil. The side effects of budesonide are limited to a small, transient reduction in growth velocity. (C) 2000, Massachusetts Medical Society.",
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TY - JOUR

T1 - Long-term effects of budesonide or nedocromil in children with asthma

AU - Tonascia, James A

AU - Adkinson, N Franklin

AU - Bender, B.

AU - Cherniack, R.

AU - Donithan, M.

AU - Kelly, H. W.

AU - Reisman, J.

AU - Shapiro, G. G.

AU - Sternberg, Alice L

AU - Strunk, R.

AU - Taggart, V.

AU - Van Natta, Mark L

AU - Wise, Robert A

AU - Wu, M.

AU - Zeiger, R.

AU - Altman, L. C.

AU - Becker, J. W.

AU - Bierman, C. W.

AU - Chinn, T.

AU - Crawford, D.

AU - Duhamel, T. R.

AU - Eliassen, H.

AU - Furukawa, C. T.

AU - Hammond, B.

AU - Kennedy, M. S.

AU - Lasley, M. V.

AU - Minotti, D. A.

AU - Reagan, C.

AU - Sharpe, M.

AU - Virant, F. S.

AU - White, G.

AU - Wighton, T. G.

AU - Williams, P. V.

AU - Weiss, S.

AU - Babigian, S.

AU - Barrant, P.

AU - Benson, L.

AU - Caicedo, J.

AU - Calder, T.

AU - DeFilippo, A.

AU - Dorsainvil, C.

AU - Erickson, J.

AU - Fulton, P.

AU - Gilbert, J.

AU - Grace, M.

AU - Greineder, D.

AU - Haynes, S.

AU - Higham, M.

AU - Jakubowski, D.

AU - Kelleher, S.

AU - Koslof, J.

AU - Madden, N.

AU - Mandel, D.

AU - Martinez, A.

AU - McAuliffe, J.

AU - Pacella, P.

AU - Parks, P.

AU - Plunkett, A.

AU - Sagarin, J.

AU - Seligsohn, K.

AU - Syring, M.

AU - Tata, M.

AU - Torda, W.

AU - Traylor, J.

AU - Van Horn, M.

AU - Wells, C.

AU - Whitman, A.

AU - Benedet, Y.

AU - Carpenter, S.

AU - Chay, J.

AU - Collinson, M.

AU - Finlayson-Kulchin, J.

AU - Gore, K.

AU - Hall, A.

AU - Holmes, N.

AU - Klassen, S.

AU - Levison, H.

AU - MacLusky, I.

AU - Miki, M.

AU - Quenneville, J.

AU - Sananes, R.

AU - Wasson, C.

AU - Bollers, N.

AU - Eggleston, P.

AU - Huss, Karen

AU - Hyatt, K.

AU - Leritz, B.

AU - Pessaro, M.

AU - Philips, S.

AU - Plotnick, L.

AU - Pulsifer, M.

AU - Rand, Cynthia S

AU - Wheeler, B.

AU - Szefler, S.

AU - Brelsford, K.

AU - Bridges, J.

AU - Ciacco, J.

AU - Covar, R.

PY - 2000/10/12

Y1 - 2000/10/12

N2 - Background: Antiinflammatory therapies, such as inhaled corticosteroids or nedocromil, are recommended for children with asthma, although there is limited information on their long-term use. Methods: We randomly assigned 1041 children from 5 through 12 years of age with mild-to-moderate asthma to receive 200 μg of budesonide (311 children), 8 mg of nedocromil (312 children), or placebo (418 children) twice daily. We treated the participants for four to six years. All children used albuterol for asthma symptoms. Results: There was no significant difference between either treatment and placebo in the primary outcome, the degree of change in the forced expiratory volume in one second (FEV1, expressed as a percentage of the predicted value) after the administration of a bronchodilator. As compared with the children assigned to placebo, the children assigned to receive budesonide had a significantly smaller decline in the ratio of FEV1 to forced vital capacity (FVC, expressed as a percentage) before the administration of a bronchodilator (decline in FEV1:FVC, 0.2 percent vs. 1.8 percent). The children given budesonide also had lower airway responsiveness to methacholine, fewer hospitalizations (2.5 vs. 4.4 per 100 person-years), fewer urgent visits to a caregiver (12 vs. 22 per 100 person-years), greater reduction in the need for albuterol for symptoms, fewer courses of prednisone, and a smaller percentage of days on which additional asthma medications were needed. As compared with placebo, nedocromil significantly reduced urgent care visits (16 vs. 22 per 100 person-years) and courses of prednisone. The mean increase in height in the budesonide group was 1.1 cm less than in the placebo group (22.7 vs. 23.8 cm, P=0.005); this difference was evident mostly within the first year. The height increase was similar in the nedocromil and placebo groups. Conclusions: In children with mild-to-moderate asthma, neither budesonide nor nedocromil is better than placebo in terms of lung function, but inhaled budesonide improves airway responsiveness and provides better control of asthma than placebo or nedocromil. The side effects of budesonide are limited to a small, transient reduction in growth velocity. (C) 2000, Massachusetts Medical Society.

AB - Background: Antiinflammatory therapies, such as inhaled corticosteroids or nedocromil, are recommended for children with asthma, although there is limited information on their long-term use. Methods: We randomly assigned 1041 children from 5 through 12 years of age with mild-to-moderate asthma to receive 200 μg of budesonide (311 children), 8 mg of nedocromil (312 children), or placebo (418 children) twice daily. We treated the participants for four to six years. All children used albuterol for asthma symptoms. Results: There was no significant difference between either treatment and placebo in the primary outcome, the degree of change in the forced expiratory volume in one second (FEV1, expressed as a percentage of the predicted value) after the administration of a bronchodilator. As compared with the children assigned to placebo, the children assigned to receive budesonide had a significantly smaller decline in the ratio of FEV1 to forced vital capacity (FVC, expressed as a percentage) before the administration of a bronchodilator (decline in FEV1:FVC, 0.2 percent vs. 1.8 percent). The children given budesonide also had lower airway responsiveness to methacholine, fewer hospitalizations (2.5 vs. 4.4 per 100 person-years), fewer urgent visits to a caregiver (12 vs. 22 per 100 person-years), greater reduction in the need for albuterol for symptoms, fewer courses of prednisone, and a smaller percentage of days on which additional asthma medications were needed. As compared with placebo, nedocromil significantly reduced urgent care visits (16 vs. 22 per 100 person-years) and courses of prednisone. The mean increase in height in the budesonide group was 1.1 cm less than in the placebo group (22.7 vs. 23.8 cm, P=0.005); this difference was evident mostly within the first year. The height increase was similar in the nedocromil and placebo groups. Conclusions: In children with mild-to-moderate asthma, neither budesonide nor nedocromil is better than placebo in terms of lung function, but inhaled budesonide improves airway responsiveness and provides better control of asthma than placebo or nedocromil. The side effects of budesonide are limited to a small, transient reduction in growth velocity. (C) 2000, Massachusetts Medical Society.

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UR - http://www.scopus.com/inward/citedby.url?scp=0034642066&partnerID=8YFLogxK

U2 - 10.1056/NEJM200010123431501

DO - 10.1056/NEJM200010123431501

M3 - Article

VL - 343

SP - 1054

EP - 1063

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 15

ER -