Episodic use of an inhaled corticosteroid or leukotriene receptor antagonist in preschool children with moderate-to-severe intermittent wheezing

Leonard B. Bacharier, Brenda R. Phillips, Robert S. Zeiger, Stanley J. Szefler, Fernando D. Martinez, Robert F. Lemanske, Christine A. Sorkness, Gordon R. Bloomberg, Wayne J. Morgan, Ian Paul, Theresa Guilbert, Marzena Krawiec, Ronina Covar, Gary Larsen, Michael Mellon, Mark H. Moss, Vernon Chinchilli, Lynn M. Taussig, Robert C. Strunk

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Abstract

Background: Acute wheezing illnesses in preschoolers require better management strategies to reduce morbidity. Objectives: We sought to examine the effectiveness of episodic use of an inhaled corticosteroid and a leukotriene receptor antagonist in preschoolers with intermittent wheezing. Methods: In a randomized, double-blind, placebo-controlled 12-month trial, 238 children aged 12 to 59 months with moderate-to-severe intermittent wheezing received 7 days of either budesonide inhalation suspension (1 mg twice daily), montelukast (4 mg daily), or placebo in addition to albuterol with each identified respiratory tract illness (RTI). Proportion of episode-free days (EFDs) during the 12-month trial was the primary outcome. Results: The 3 treatment groups did not differ in proportions of EFDs, with adjusted mean EFDs of 76% (95% CI, 70% to 81%) for budesonide, 73% (95% CI, 66% to 79%) for montelukast, and 74% (95% CI, 65% to 81%) for conventional therapy (P = .66). The 3 groups did not differ in oral corticosteroid use, health care use, quality of life, or linear growth. However, during RTIs, budesonide and montelukast therapy led to modest reductions in trouble breathing (38% [P = .003] and 37% [P = .003], respectively) and interference with activity scores (32% [P = .01] and 40% [P = .001], respectively) that were most evident in those with positive asthma predictive indices. Conclusions: In preschool children with moderate-to-severe intermittent wheezing, episodic use of either budesonide or montelukast early in RTIs, when added to albuterol, did not increase the proportion of EFDs or decrease oral corticosteroid use over a 12-month period. However, indicators of severity of acute illnesses were reduced, particularly in children with positive asthma predictive indices.

Original languageEnglish (US)
JournalJournal of Allergy and Clinical Immunology
Volume122
Issue number6
DOIs
StatePublished - Jan 1 2008

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montelukast
Leukotriene Antagonists
Budesonide
Steroid Receptors
Respiratory Sounds
Preschool Children
Adrenal Cortex Hormones
Albuterol
Asthma
Placebos
Respiratory System
Inhalation
Suspensions
Respiration
Therapeutics
Quality of Life
Morbidity
Delivery of Health Care
Growth

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Immunology

Cite this

Bacharier, Leonard B. ; Phillips, Brenda R. ; Zeiger, Robert S. ; Szefler, Stanley J. ; Martinez, Fernando D. ; Lemanske, Robert F. ; Sorkness, Christine A. ; Bloomberg, Gordon R. ; Morgan, Wayne J. ; Paul, Ian ; Guilbert, Theresa ; Krawiec, Marzena ; Covar, Ronina ; Larsen, Gary ; Mellon, Michael ; Moss, Mark H. ; Chinchilli, Vernon ; Taussig, Lynn M. ; Strunk, Robert C. / Episodic use of an inhaled corticosteroid or leukotriene receptor antagonist in preschool children with moderate-to-severe intermittent wheezing. In: Journal of Allergy and Clinical Immunology. 2008 ; Vol. 122, No. 6.
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title = "Episodic use of an inhaled corticosteroid or leukotriene receptor antagonist in preschool children with moderate-to-severe intermittent wheezing",
abstract = "Background: Acute wheezing illnesses in preschoolers require better management strategies to reduce morbidity. Objectives: We sought to examine the effectiveness of episodic use of an inhaled corticosteroid and a leukotriene receptor antagonist in preschoolers with intermittent wheezing. Methods: In a randomized, double-blind, placebo-controlled 12-month trial, 238 children aged 12 to 59 months with moderate-to-severe intermittent wheezing received 7 days of either budesonide inhalation suspension (1 mg twice daily), montelukast (4 mg daily), or placebo in addition to albuterol with each identified respiratory tract illness (RTI). Proportion of episode-free days (EFDs) during the 12-month trial was the primary outcome. Results: The 3 treatment groups did not differ in proportions of EFDs, with adjusted mean EFDs of 76{\%} (95{\%} CI, 70{\%} to 81{\%}) for budesonide, 73{\%} (95{\%} CI, 66{\%} to 79{\%}) for montelukast, and 74{\%} (95{\%} CI, 65{\%} to 81{\%}) for conventional therapy (P = .66). The 3 groups did not differ in oral corticosteroid use, health care use, quality of life, or linear growth. However, during RTIs, budesonide and montelukast therapy led to modest reductions in trouble breathing (38{\%} [P = .003] and 37{\%} [P = .003], respectively) and interference with activity scores (32{\%} [P = .01] and 40{\%} [P = .001], respectively) that were most evident in those with positive asthma predictive indices. Conclusions: In preschool children with moderate-to-severe intermittent wheezing, episodic use of either budesonide or montelukast early in RTIs, when added to albuterol, did not increase the proportion of EFDs or decrease oral corticosteroid use over a 12-month period. However, indicators of severity of acute illnesses were reduced, particularly in children with positive asthma predictive indices.",
author = "Bacharier, {Leonard B.} and Phillips, {Brenda R.} and Zeiger, {Robert S.} and Szefler, {Stanley J.} and Martinez, {Fernando D.} and Lemanske, {Robert F.} and Sorkness, {Christine A.} and Bloomberg, {Gordon R.} and Morgan, {Wayne J.} and Ian Paul and Theresa Guilbert and Marzena Krawiec and Ronina Covar and Gary Larsen and Michael Mellon and Moss, {Mark H.} and Vernon Chinchilli and Taussig, {Lynn M.} and Strunk, {Robert C.}",
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Bacharier, LB, Phillips, BR, Zeiger, RS, Szefler, SJ, Martinez, FD, Lemanske, RF, Sorkness, CA, Bloomberg, GR, Morgan, WJ, Paul, I, Guilbert, T, Krawiec, M, Covar, R, Larsen, G, Mellon, M, Moss, MH, Chinchilli, V, Taussig, LM & Strunk, RC 2008, 'Episodic use of an inhaled corticosteroid or leukotriene receptor antagonist in preschool children with moderate-to-severe intermittent wheezing', Journal of Allergy and Clinical Immunology, vol. 122, no. 6. https://doi.org/10.1016/j.jaci.2008.09.029

Episodic use of an inhaled corticosteroid or leukotriene receptor antagonist in preschool children with moderate-to-severe intermittent wheezing. / Bacharier, Leonard B.; Phillips, Brenda R.; Zeiger, Robert S.; Szefler, Stanley J.; Martinez, Fernando D.; Lemanske, Robert F.; Sorkness, Christine A.; Bloomberg, Gordon R.; Morgan, Wayne J.; Paul, Ian; Guilbert, Theresa; Krawiec, Marzena; Covar, Ronina; Larsen, Gary; Mellon, Michael; Moss, Mark H.; Chinchilli, Vernon; Taussig, Lynn M.; Strunk, Robert C.

In: Journal of Allergy and Clinical Immunology, Vol. 122, No. 6, 01.01.2008.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Episodic use of an inhaled corticosteroid or leukotriene receptor antagonist in preschool children with moderate-to-severe intermittent wheezing

AU - Bacharier, Leonard B.

AU - Phillips, Brenda R.

AU - Zeiger, Robert S.

AU - Szefler, Stanley J.

AU - Martinez, Fernando D.

AU - Lemanske, Robert F.

AU - Sorkness, Christine A.

AU - Bloomberg, Gordon R.

AU - Morgan, Wayne J.

AU - Paul, Ian

AU - Guilbert, Theresa

AU - Krawiec, Marzena

AU - Covar, Ronina

AU - Larsen, Gary

AU - Mellon, Michael

AU - Moss, Mark H.

AU - Chinchilli, Vernon

AU - Taussig, Lynn M.

AU - Strunk, Robert C.

PY - 2008/1/1

Y1 - 2008/1/1

N2 - Background: Acute wheezing illnesses in preschoolers require better management strategies to reduce morbidity. Objectives: We sought to examine the effectiveness of episodic use of an inhaled corticosteroid and a leukotriene receptor antagonist in preschoolers with intermittent wheezing. Methods: In a randomized, double-blind, placebo-controlled 12-month trial, 238 children aged 12 to 59 months with moderate-to-severe intermittent wheezing received 7 days of either budesonide inhalation suspension (1 mg twice daily), montelukast (4 mg daily), or placebo in addition to albuterol with each identified respiratory tract illness (RTI). Proportion of episode-free days (EFDs) during the 12-month trial was the primary outcome. Results: The 3 treatment groups did not differ in proportions of EFDs, with adjusted mean EFDs of 76% (95% CI, 70% to 81%) for budesonide, 73% (95% CI, 66% to 79%) for montelukast, and 74% (95% CI, 65% to 81%) for conventional therapy (P = .66). The 3 groups did not differ in oral corticosteroid use, health care use, quality of life, or linear growth. However, during RTIs, budesonide and montelukast therapy led to modest reductions in trouble breathing (38% [P = .003] and 37% [P = .003], respectively) and interference with activity scores (32% [P = .01] and 40% [P = .001], respectively) that were most evident in those with positive asthma predictive indices. Conclusions: In preschool children with moderate-to-severe intermittent wheezing, episodic use of either budesonide or montelukast early in RTIs, when added to albuterol, did not increase the proportion of EFDs or decrease oral corticosteroid use over a 12-month period. However, indicators of severity of acute illnesses were reduced, particularly in children with positive asthma predictive indices.

AB - Background: Acute wheezing illnesses in preschoolers require better management strategies to reduce morbidity. Objectives: We sought to examine the effectiveness of episodic use of an inhaled corticosteroid and a leukotriene receptor antagonist in preschoolers with intermittent wheezing. Methods: In a randomized, double-blind, placebo-controlled 12-month trial, 238 children aged 12 to 59 months with moderate-to-severe intermittent wheezing received 7 days of either budesonide inhalation suspension (1 mg twice daily), montelukast (4 mg daily), or placebo in addition to albuterol with each identified respiratory tract illness (RTI). Proportion of episode-free days (EFDs) during the 12-month trial was the primary outcome. Results: The 3 treatment groups did not differ in proportions of EFDs, with adjusted mean EFDs of 76% (95% CI, 70% to 81%) for budesonide, 73% (95% CI, 66% to 79%) for montelukast, and 74% (95% CI, 65% to 81%) for conventional therapy (P = .66). The 3 groups did not differ in oral corticosteroid use, health care use, quality of life, or linear growth. However, during RTIs, budesonide and montelukast therapy led to modest reductions in trouble breathing (38% [P = .003] and 37% [P = .003], respectively) and interference with activity scores (32% [P = .01] and 40% [P = .001], respectively) that were most evident in those with positive asthma predictive indices. Conclusions: In preschool children with moderate-to-severe intermittent wheezing, episodic use of either budesonide or montelukast early in RTIs, when added to albuterol, did not increase the proportion of EFDs or decrease oral corticosteroid use over a 12-month period. However, indicators of severity of acute illnesses were reduced, particularly in children with positive asthma predictive indices.

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U2 - 10.1016/j.jaci.2008.09.029

DO - 10.1016/j.jaci.2008.09.029

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