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The effect of nedocromil sodium on histamine responsiveness in clinically stable asthmatic children
A L Foo1, C J Lanteri, P R Burton
1Division of Clinical Sciences, Western Australian Research Institute for Child Health, Perth.
Insights
Nedocromil sodium improved pulmonary function in stable asthmatic children. However, it did not alter histamine responsiveness, suggesting this measure is not key to asthma control in pediatric patients.
Area of Science:
- Pediatric Pulmonology
- Clinical Pharmacology
Background:
- Asthma affects many children, with some exhibiting abnormal pulmonary function even when clinically stable.
- Histamine responsiveness is a potential marker for asthma control.
Purpose of the Study:
- To evaluate the efficacy of nedocromil sodium in improving pulmonary function and reducing histamine responsiveness in children with asthma.
- To determine the relationship between histamine responsiveness and asthma control in pediatric patients.
Main Methods:
- A double-blind, randomized, placebo-controlled study involving 120 clinically stable asthmatic children (aged 6-19 years).
- Participants received either nedocromil sodium (4 mg TID) or placebo for 8 weeks.
- Pulmonary function and histamine responsiveness were assessed at baseline and after 4 and 8 weeks.
Main Results:
- Nedocromil sodium treatment led to statistically significant improvements in pulmonary function (p=0.01).
- 52% of participants on nedocromil sodium with abnormal baseline pulmonary function normalized, compared to 11% on placebo.
- No significant differences in histamine responsiveness were observed between the nedocromil sodium and placebo groups throughout the study.
Conclusions:
- Nedocromil sodium effectively improves pulmonary function in clinically stable asthmatic children.
- Histamine responsiveness does not appear to be closely linked to the level of asthma control in this pediatric population.
Abstract:
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.