Double-blind, randomized, placebo-controlled trial of effect of nedocromilsodium on clinical and inflammatory parameters of asthma in children allergic to dust mite

Background: The purpose of this study was to determine the clinical effect of nedocromil sodium and its relationship with serum levels of inflammatory mediators by monitoring lung function and noninvasive markers of airway in flammation, such as eosinophil brood counts; serum ECP, sIL-2R, IL-4 and sI CAM; and total IgE. Anti-inflammatory medications cause a reduction in the markers of airway inflammation, decrease the intensity of airway hyperrespo nsiveness, and improve clinical symptoms of asthma. Among the available cho ices is nedocromil sodium, which is favored in the treatment of asthmatic c hildren due to its very mild side-effects. It has been previously shown to improve the clinical parameters of asthma, but there are limited data on it s effect on inflammatory mediators in the serum of asthmatic children. Methods: In this double-blind, randomized, placebo-controlled 8-week trial, 39 children, aged 9-16 years, with moderate atopic asthma were randomly al located to receive either nedocromil sodium, two puffs twice daily, 0.002 g /puff, or placebo, two puffs twice daily. The primary end points were the c linical parameters of asthma measured by asthma symptom score, FEV1, and PC 20H. Other end points included the serum levels of various inflammatory mar kers ECP, sIL-2R, IL-4, sICAM, and IgE. Results: Clinical and inflammatory parameters improved with the use of nedo cromil sodium, compared with placebo. Nedocromil significantly decreased se rum levels of inflammatory markers, as shown in the following table. No cor relation was found between any of the measured parameters. [GRAPHICS] Conclusions: Nedocromil sodium provided effective anti-inflammatory treatme nt for children with moderate atopic asthma.