Levels of pro-allergic
cytokine IL-4 are increased in asthmatic airways, contributing to allergic
inflammation.
IL-4 and
IL-13 are the most important factors in production of class E
immunoglobulin, playing major role in childhood atopic
asthma. The mechanism of effect of
nedocromil, often prescribed in children, has been discussed. Our previous study on the effect of
nedocromil on different inflammatory markers, showed decreased levels of
IL-4 and
IgE after monotherapy in 15 asthmatic children. The purpose of this study was to define the effect of treatment with
nedocromil on serum level of
IL-4 and
IgE, clinical symptoms and
bronchial hyperreactivity (BHR) in children with moderate atopic
asthma. It was 8 week, placebo-controlled and randomized, double blind trial of 81 children with moderate atopic
asthma allergic to dust mite. Patients were randomly allocated to receive
nedocromil sodium two puffs four times daily (0.002 g/puff) (n = 34) or placebo (n = 47). 69 children completed the study.
After treatment with
nedocromil the levels of
IL-4 and
IgE in blood serum in study group significantly decreased, and all clinical parameters improved. Mean levels of
IL-4 in serum before and
after treatment with
nedocromil were 0.13 pg/ml +/- 0.01 and 0.12 pg/ml +/- 0.02 respectively (p < 0.01). Mean serum levels of
IgE before and
after treatment with
nedocromil were 556.83 IU/ml +/- 201.3 and 485 IU/ml +/- 200.5 respectively (p < 0.02). This study demonstrate that one possible way by which
nedocromil contribute to inhibition of allergic
inflammation is by decreasing
IL-4 and
IgE levels.