The effect of nedocromil sodium on histamine responsiveness in clinically stable asthmatic children.
A double-blind, randomized, placebo-controlled, parallel-group study was undertaken in 120 clinically stable asthmatic children (aged 6-19 years) to determine the ability of 8 weeks of treatment with nedocromil sodium (4 mg, three times a day) to reduce the level of histamine responsiveness. Despite the subjects being clinically stable and reporting few asthma symptoms, approximately one-third had abnormal pulmonary function on enrollment into the study. Statistically significant increases in pulmonary function were seen in the group treated with nedocromil sodium but not in the control group (p = 0.01). Furthermore, 52% of the individuals with abnormal pulmonary function returned to normal following treatment with nedocromil sodium compared to 11% of those with abnormal pulmonary function who received placebo. However, there were no differences in the level of histamine responsiveness between the two treatment groups at baseline or after 4 or 8 weeks of treatment with nedocromil sodium or placebo. These data suggest that the level of histamine responsiveness is not intimately related to the level of asthma control in children.
Foo
A L
AL
Division of Clinical Sciences, Western Australian Research Institute for Child Health, Perth.
Lanteri
C J
CJ
Burton
P R
PR
Sly
P D
PD
D000293:Adolescent; D001249:Asthma / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D016535:Bronchial Hyperreactivity / Q000503:physiopathology*; D001985:Bronchial Provocation Tests; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006632:Histamine; D006801:Humans; D008297:Male; D017835:Nedocromil / Q000008:administration & dosage / Q000627:therapeutic use*; D012129:Respiratory Function Tests; D013997:Time Factors
D017835:Nedocromil; D006632:Histamine