The back to school asthma study: The effect of montelukast on asthma burden when initiated prophylactically at the start of the school year

Kevin B. Weiss; James E. Gern; Neil W. Johnston; Malcolm R. Sears; Craig A. Jones; Gang Jia; Molly W. Watkins; Steven S. Smugar; Jonathan M. Edelman; Evalyn N. Grant

doi:10.1016/j.anai.2010.04.018

The back to school asthma study: The effect of montelukast on asthma burden when initiated prophylactically at the start of the school year

Kevin B. Weiss, James E. Gern, Neil W. Johnston, Malcolm R. Sears, Craig A. Jones, Gang Jia, Molly W. Watkins, Steven S. Smugar, Jonathan M. Edelman, Evalyn N. Grant

Medicine, General Medicine Division

Research output: Contribution to journal › Article › peer-review

22 Scopus citations

Abstract

Background: Pediatric asthma hospitalizations peak in early autumn. Objective: To determine the effectiveness of montelukast therapy in reducing the asthma burden in children when initiated prophylactically on school return. Methods: This was a randomized, multicenter, double-blind, placebo-controlled study of children with asthma aged 6 to 14 years. No minimum asthma symptoms were required, and patients could continue inhaled corticosteroid (ICS) use. Montelukast, 5 mg, chewable tablet (n = 580) or matching placebo (n = 582) was taken the night before the first day of school and nightly thereafter for 8 weeks. The primary end point was the percentage of days with worsening asthma, defined by one of the following: (1) increased β-agonist use, (2) increased daytime symptoms, (3) awake "all night," (4) oral corticosteroid rescue or increased ICS use for worsening asthma, or (5) unanticipated health care utilization. Results: The reduction in the percentage of days with worsening asthma with montelukast use versus placebo use was not significant (24.3% vs 27.2%, P = .07). Prespecified subgroup analyses demonstrated nonsignificant trends favoring montelukast therapy in boys and older children but no effect by baseline ICS use or history of cold symptoms. Post hoc analysis showed a nonsignificant trend favoring montelukast therapy in reducing worsening asthma days for children commencing school after August 15 compared with earlier commencement. Conclusions: Montelukast use was not significantly more effective than was placebo use in reducing the percentage of days with worsening asthma when initiated at the start of the school year. The effect of montelukast treatment on the fall peak in asthma burden may depend on sex, age, and the date of school return.

Original language	English (US)
Pages (from-to)	174-181
Number of pages	8
Journal	Annals of Allergy, Asthma and Immunology
Volume	105
Issue number	2
DOIs	https://doi.org/10.1016/j.anai.2010.04.018
State	Published - Aug 2010

Funding

Funding Sources: This study was supported by Merck & Co Inc. Disclosures: Dr Weiss served as a consultant on the scientific advisory committee for this study. Dr Gern was on the scientific advisory committee for this study, receives grant support for clinical research from Merck and AstraZeneca , receives speaking fees from Merck, and is on an advisory panel at GlaxoSmithKline. Mr Johnston was on the scientific advisory committee for this study and has received research funding and honoraria from Merck Frosst Canada , AstraZeneca PLC , and GlaxoSmithKline Canada . Dr Sears was on the scientific advisory committee for this study; has received research funding from AstraZeneca and Merck Frosst Canada and consultation fees and honoraria from AstraZeneca, GlaxoSmithKline, Merck Frosst Canada, and Nycomed; and holds a chair in respiratory epidemiology jointly endowed by AstraZeneca and McMaster University. Dr Jones was on the scientific advisory committee for this study and has done consulting and advisory work for Merck and Genentech. Drs Gia, Smugar, Edelman, and Grant and Ms Watkins are employees of Merck & Co Inc and may own stock or have stock options in the company.

ASJC Scopus subject areas

Pulmonary and Respiratory Medicine
Immunology and Allergy
Immunology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.anai.2010.04.018

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Weiss, K. B., Gern, J. E., Johnston, N. W., Sears, M. R., Jones, C. A., Jia, G., Watkins, M. W., Smugar, S. S., Edelman, J. M., & Grant, E. N. (2010). The back to school asthma study: The effect of montelukast on asthma burden when initiated prophylactically at the start of the school year. Annals of Allergy, Asthma and Immunology, 105(2), 174-181. https://doi.org/10.1016/j.anai.2010.04.018

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title = "The back to school asthma study: The effect of montelukast on asthma burden when initiated prophylactically at the start of the school year",

abstract = "Background: Pediatric asthma hospitalizations peak in early autumn. Objective: To determine the effectiveness of montelukast therapy in reducing the asthma burden in children when initiated prophylactically on school return. Methods: This was a randomized, multicenter, double-blind, placebo-controlled study of children with asthma aged 6 to 14 years. No minimum asthma symptoms were required, and patients could continue inhaled corticosteroid (ICS) use. Montelukast, 5 mg, chewable tablet (n = 580) or matching placebo (n = 582) was taken the night before the first day of school and nightly thereafter for 8 weeks. The primary end point was the percentage of days with worsening asthma, defined by one of the following: (1) increased β-agonist use, (2) increased daytime symptoms, (3) awake {"}all night,{"} (4) oral corticosteroid rescue or increased ICS use for worsening asthma, or (5) unanticipated health care utilization. Results: The reduction in the percentage of days with worsening asthma with montelukast use versus placebo use was not significant (24.3% vs 27.2%, P = .07). Prespecified subgroup analyses demonstrated nonsignificant trends favoring montelukast therapy in boys and older children but no effect by baseline ICS use or history of cold symptoms. Post hoc analysis showed a nonsignificant trend favoring montelukast therapy in reducing worsening asthma days for children commencing school after August 15 compared with earlier commencement. Conclusions: Montelukast use was not significantly more effective than was placebo use in reducing the percentage of days with worsening asthma when initiated at the start of the school year. The effect of montelukast treatment on the fall peak in asthma burden may depend on sex, age, and the date of school return.",

author = "Weiss, {Kevin B.} and Gern, {James E.} and Johnston, {Neil W.} and Sears, {Malcolm R.} and Jones, {Craig A.} and Gang Jia and Watkins, {Molly W.} and Smugar, {Steven S.} and Edelman, {Jonathan M.} and Grant, {Evalyn N.}",

note = "Funding Information: Funding Sources: This study was supported by Merck & Co Inc. Funding Information: Disclosures: Dr Weiss served as a consultant on the scientific advisory committee for this study. Dr Gern was on the scientific advisory committee for this study, receives grant support for clinical research from Merck and AstraZeneca , receives speaking fees from Merck, and is on an advisory panel at GlaxoSmithKline. Mr Johnston was on the scientific advisory committee for this study and has received research funding and honoraria from Merck Frosst Canada , AstraZeneca PLC , and GlaxoSmithKline Canada . Dr Sears was on the scientific advisory committee for this study; has received research funding from AstraZeneca and Merck Frosst Canada and consultation fees and honoraria from AstraZeneca, GlaxoSmithKline, Merck Frosst Canada, and Nycomed; and holds a chair in respiratory epidemiology jointly endowed by AstraZeneca and McMaster University. Dr Jones was on the scientific advisory committee for this study and has done consulting and advisory work for Merck and Genentech. Drs Gia, Smugar, Edelman, and Grant and Ms Watkins are employees of Merck & Co Inc and may own stock or have stock options in the company. ",

year = "2010",

month = aug,

doi = "10.1016/j.anai.2010.04.018",

language = "English (US)",

volume = "105",

pages = "174--181",

journal = "Annals of Allergy, Asthma and Immunology",

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number = "2",

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Weiss, KB, Gern, JE, Johnston, NW, Sears, MR, Jones, CA, Jia, G, Watkins, MW, Smugar, SS, Edelman, JM & Grant, EN 2010, 'The back to school asthma study: The effect of montelukast on asthma burden when initiated prophylactically at the start of the school year', Annals of Allergy, Asthma and Immunology, vol. 105, no. 2, pp. 174-181. https://doi.org/10.1016/j.anai.2010.04.018

TY - JOUR

T1 - The back to school asthma study

T2 - The effect of montelukast on asthma burden when initiated prophylactically at the start of the school year

AU - Weiss, Kevin B.

AU - Gern, James E.

AU - Johnston, Neil W.

AU - Sears, Malcolm R.

AU - Jones, Craig A.

AU - Jia, Gang

AU - Watkins, Molly W.

AU - Smugar, Steven S.

AU - Edelman, Jonathan M.

AU - Grant, Evalyn N.

N1 - Funding Information: Funding Sources: This study was supported by Merck & Co Inc. Funding Information: Disclosures: Dr Weiss served as a consultant on the scientific advisory committee for this study. Dr Gern was on the scientific advisory committee for this study, receives grant support for clinical research from Merck and AstraZeneca , receives speaking fees from Merck, and is on an advisory panel at GlaxoSmithKline. Mr Johnston was on the scientific advisory committee for this study and has received research funding and honoraria from Merck Frosst Canada , AstraZeneca PLC , and GlaxoSmithKline Canada . Dr Sears was on the scientific advisory committee for this study; has received research funding from AstraZeneca and Merck Frosst Canada and consultation fees and honoraria from AstraZeneca, GlaxoSmithKline, Merck Frosst Canada, and Nycomed; and holds a chair in respiratory epidemiology jointly endowed by AstraZeneca and McMaster University. Dr Jones was on the scientific advisory committee for this study and has done consulting and advisory work for Merck and Genentech. Drs Gia, Smugar, Edelman, and Grant and Ms Watkins are employees of Merck & Co Inc and may own stock or have stock options in the company.

PY - 2010/8

Y1 - 2010/8

N2 - Background: Pediatric asthma hospitalizations peak in early autumn. Objective: To determine the effectiveness of montelukast therapy in reducing the asthma burden in children when initiated prophylactically on school return. Methods: This was a randomized, multicenter, double-blind, placebo-controlled study of children with asthma aged 6 to 14 years. No minimum asthma symptoms were required, and patients could continue inhaled corticosteroid (ICS) use. Montelukast, 5 mg, chewable tablet (n = 580) or matching placebo (n = 582) was taken the night before the first day of school and nightly thereafter for 8 weeks. The primary end point was the percentage of days with worsening asthma, defined by one of the following: (1) increased β-agonist use, (2) increased daytime symptoms, (3) awake "all night," (4) oral corticosteroid rescue or increased ICS use for worsening asthma, or (5) unanticipated health care utilization. Results: The reduction in the percentage of days with worsening asthma with montelukast use versus placebo use was not significant (24.3% vs 27.2%, P = .07). Prespecified subgroup analyses demonstrated nonsignificant trends favoring montelukast therapy in boys and older children but no effect by baseline ICS use or history of cold symptoms. Post hoc analysis showed a nonsignificant trend favoring montelukast therapy in reducing worsening asthma days for children commencing school after August 15 compared with earlier commencement. Conclusions: Montelukast use was not significantly more effective than was placebo use in reducing the percentage of days with worsening asthma when initiated at the start of the school year. The effect of montelukast treatment on the fall peak in asthma burden may depend on sex, age, and the date of school return.

AB - Background: Pediatric asthma hospitalizations peak in early autumn. Objective: To determine the effectiveness of montelukast therapy in reducing the asthma burden in children when initiated prophylactically on school return. Methods: This was a randomized, multicenter, double-blind, placebo-controlled study of children with asthma aged 6 to 14 years. No minimum asthma symptoms were required, and patients could continue inhaled corticosteroid (ICS) use. Montelukast, 5 mg, chewable tablet (n = 580) or matching placebo (n = 582) was taken the night before the first day of school and nightly thereafter for 8 weeks. The primary end point was the percentage of days with worsening asthma, defined by one of the following: (1) increased β-agonist use, (2) increased daytime symptoms, (3) awake "all night," (4) oral corticosteroid rescue or increased ICS use for worsening asthma, or (5) unanticipated health care utilization. Results: The reduction in the percentage of days with worsening asthma with montelukast use versus placebo use was not significant (24.3% vs 27.2%, P = .07). Prespecified subgroup analyses demonstrated nonsignificant trends favoring montelukast therapy in boys and older children but no effect by baseline ICS use or history of cold symptoms. Post hoc analysis showed a nonsignificant trend favoring montelukast therapy in reducing worsening asthma days for children commencing school after August 15 compared with earlier commencement. Conclusions: Montelukast use was not significantly more effective than was placebo use in reducing the percentage of days with worsening asthma when initiated at the start of the school year. The effect of montelukast treatment on the fall peak in asthma burden may depend on sex, age, and the date of school return.

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The back to school asthma study: The effect of montelukast on asthma burden when initiated prophylactically at the start of the school year

Abstract

Funding

ASJC Scopus subject areas

UN SDGs

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