In preschool children at high risk for asthma, two years of inhaled-corticosteroid therapy did not change the development of asthma symptoms or lung function during a third, treatment-free year. These findings do not provide support for a subsequent disease-modifying effect of inhaled corticosteroids after the treatment is discontinued. (ClinicalTrials.gov number, NCT00272441.).

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Background Acute wheezing illnesses in preschoolers need better management strategies to reduce morbidity. Objectives 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 twelve-month trial, 238 children aged 12-59 months with moderate-severe intermittent wheezing received 7-days of either budesonide inhalation suspension (1mg twice daily), montelukast (4mg daily), or placebos in addition to albuterol with each identified respiratory tract illness. Proportion of episode-free days (EFDs) during the 12-month trial was the primary outcome. Results The three treatment groups did not differ in proportions of EFDs, with adjusted mean (95% CI) EFDs of 76% (70%, 81%) for budesonide, 73% (66%, 79%) for montelukast, and 74% (65%, 81%) for conventional therapy (p=0.66). The three groups did not differ in oral corticosteroid use, health care utilization, quality of life, or linear growth. However, during respiratory tract illnesses, budesonide and montelukast therapy led to modest reductions in trouble breathing [(38% (p=0.003) and 37% (p=0.003)] and interference with activity scores [32% (p=0.01) and 40% (p=0.001)], 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 respiratory tract illnesses, when added to albuterol, did not increase the proportion of EFDs or decrease oral corticosteroid use over a twelve-month period. However, indicators of severity of acute illnesses were reduced, particularly in children with positive asthma predictive indices. Capsule Summary The episodic use of budesonide or montelukast in preschool children with moderate-to-severe intermittent wheezing does not increase the proportion of episode free days, but decreases symptom severity during acute respiratory tract illnesses.

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Despite advances in understanding the pathophysiology of asthma, morbidity and mortality in pediatrics continue to rise. Little is known about the initiation and chronicity of inflammation resulting in asthma in this young population. We evaluated 20 "wheezing" children (WC) (median age 14.9 mo) with a minimum of two episodes of wheezing or prolonged wheezing > or = 2 mo in a 6-mo period with bronchoscopy and bronchoalveolar lavage (BAL). Comparisons were made with six normal controls (NC) (median age 23.3 mo) undergoing general anesthesia for elective surgery. BAL fluid cell counts and differentials were determined. The eicosanoids, leukotriene (LT) B(4), LTE(4), prostaglandin (PG)E(2), and 15-hydroxyeicosatetraenoic acid (HETE) and the mast cell mediators, beta-tryptase and PGD(2), were evaluated by enzyme immunoassay (EIA). WC had significant elevations in total BAL cells/ml (p = 0.01), as well as, lymphocytes (LYMPH, p = 0.007), macrophages/monocytes (M&M, p = 0.02), polymorphonuclear cells (PMN, p = 0.02), epithelial cells (EPI, p = 0.03), and eosinophils (EOS, p = 0.04) compared with NC. Levels of PGE(2) (p = 0.0005), 15-HETE (p = 0.002), LTE(4) (p = 0.04), and LTB(4) (p = 0.05) were also increased in WC compared with NC, whereas PGD(2) and beta-tryptase were not. This study confirms that inflammation is present in the airways of very young WC and may differ from patterns seen in adults with asthma.