THE EFFECT OF NEDOCROMIL SODIUM ON HISTAMINE RESPONSIVENESS IN CLINICALLY STABLE ASTHMATIC-CHILDREN

A double-blind, randomized, placebo-controlled, parallel-group study w as undertaken in 120 clinically stable asthmatic children (aged 6-19 y ears) to determine the ability of 8 weeks of treatment with nedocromil sodium (4 mg, three times a day) to reduce the level of histamine res ponsiveness. Despite the subjects being clinically stable and reportin g few asthma symptoms, approximately one-third had abnormal pulmonary function on enrollment into the study. Statistically significant incre ases in pulmonary function were seen in the group treated with nedocro mil sodium but not in the control group (p = 0.01). Furthermore, 52% o f the individuals with abnormal pulmonary function returned to normal following treatment with nedocromil sodium compared to 11% of those wi th abnormal pulmonary function who received placebo. However, there we re no differences in the level of histamine responsiveness between the two treatment groups at baseline or after 4 or 8 weeks of treatment w ith nedocromil sodium or placebo. These data suggest that the level of histamine responsiveness is not intimately related to the level of as thma control in children.