Episodic use of an inhaled corticosteroid or leukotriene receptor antagonist in preschool children with moderate-to-severe intermittent wheezing.
BACKGROUND
Acute wheezing illnesses in preschoolers require better management strategies to reduce morbidity.


OBJECTIVE
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.
Bacharier
Leonard B
LB
Department of Pediatrics, Washington University and St Louis Children's Hospital, St Louis, MO 63110, USA. bacharier_L@kids.wustl.edu
Phillips
Brenda R
BR
Zeiger
Robert S
RS
Szefler
Stanley J
SJ
Martinez
Fernando D
FD
Lemanske
Robert F
RF
Sorkness
Christine A
CA
Bloomberg
Gordon R
GR
Morgan
Wayne J
WJ
Paul
Ian M
IM
Guilbert
Theresa
T
Krawiec
Marzena
M
Covar
Ronina
R
Larsen
Gary
G
Mellon
Michael
M
Moss
Mark H
MH
Chinchilli
Vernon M
VM
Taussig
Lynn M
LM
Strunk
Robert C
RC
D000085:Acetates / Q000008:administration & dosage* / Q000009:adverse effects; D000280:Administration, Inhalation; D000420:Albuterol / Q000008:administration & dosage* / Q000009:adverse effects; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D019819:Budesonide / Q000008:administration & dosage* / Q000009:adverse effects; D002675:Child, Preschool; D003521:Cyclopropanes; D004311:Double-Blind Method; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007223:Infant; D020024:Leukotriene Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D011804:Quinolines / Q000008:administration & dosage* / Q000009:adverse effects; D012135:Respiratory Sounds / Q000187:drug effects* / Q000209:etiology; D012140:Respiratory Tract Diseases / Q000150:complications / Q000188:drug therapy*; D013440:Sulfides
D000085:Acetates; D001993:Bronchodilator Agents; D003521:Cyclopropanes; D005938:Glucocorticoids; D020024:Leukotriene Antagonists; D011804:Quinolines; D013440:Sulfides; D019819:Budesonide; C093875:montelukast; D000420:Albuterol