Source:Guilbert TW, Morgan WJ, Zeiger RS, et al. Long-term inhaled corticosteroids for preschool children at high risk for asthma.
N Engl J Med.
–1997; doi:10.1056/NEJ-Moa051378

Preschool children with at least 4 episodes of wheezing a year and either 1 major risk factor (a parental history of asthma or a personal history of atopic dermatitis) or 2 of 3 minor risk factors (allergic rhinitis, blood eosinophilia, and wheezing without colds) are regarded as high-risk for the subsequent development of asthma.1,2 Inhaled corticosteroids are effective in decreasing symptoms of asthma in this population.3,6 In addition, in school-aged children with asthma, therapy with inhaled steroids improves asthma clinical parameters while discontinuation of inhaled steroids results in deterioration of these parameters within months.7 However, whether inhaled corticosteroids used in the preschool years and then discontinued can prevent the development of asthma is unknown.5 The authors, from Arizona Respiratory Center and the multicenter Prevention of Early Asthma in Kids (PEAK) clinical trial group, sought to determine whether early institution of inhaled steroids at age 2 to 3 years, when disease and the chronic loss of lung function have not yet developed, could prevent subsequent development of asthma.8 

A total of 285 children aged 2–3 years, determined to be at high risk for the persistence of asthma-like symptoms during the school years based on a modified asthma predictive index, were randomly assigned to 1 of 2 treatments: Fluticasone 44 μg 2 puffs bid (Glaxo SmithKline) or matching placebo for 2 years, followed by 1 year without study treatment (the observaton year). Both groups received medication or placebo using a metered-dose inhaler and an Aerochamber with mask (Monaghan Medical). Adherence was encouraged through an educational program8 and monitored with an electronic meter (Doser). The use of rescue medication (including albuterol and oral steroids) was determined on the basis of a written action plan. The primary outcome was episode-free days, and secondary outcomes included percentage of eosinophils in the peripheral blood and the number of courses and time until use of systemic corticosteroids and controller medications. Pulse oscillometry for airway resistance, spirometry (56% completed), and aeroallergen skin testing were performed at all centers. Statistical analysis included analysis of covariance with regression analysis and contingency tables generated by SAS statistical software (version 8.2).

At baseline, the 2 groups were similar with regard to age, age at onset of asthma symptoms, age at asthma diagnosis, parental history of asthma and atopy, household pets, albuterol use, symptom-free days, ED visits, and asthma-related hospitalizations. During the observation year, there were no significant differences between the 2 groups with regard to episode-free days, number of exacerbations, or pulmonary function. During the treatment phase the inhaled corticosteroid group experienced a greater proportion of episode-free days (P=.006) and a diminished number of exacerbations (P<.001). The treatment group also showed a trend toward a lessening of reactance by oscillometry, indicating improved pulmonary compliance. The inhaled...

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