A Double-Blind Multicenter Group Comparative Study of the Efficacy and Safety of Nedocromil Sodium in the Management of Asthma: Discussion (2)
During weeks 3 to 6, when SRTs were no longer part of the patients’ treatment and oral bronchodilator medication was minimal, there were statistically significant differences in favor of nedocromil sodium for virtually every diary card and clinic variable. The nedocromil sodium-treated group was able to maintain, with the exception of night-time asthma, the improvement gained during the first two weeks and there was again a marked mean fall in the severity of asthma assessed at the end of week 6.
There were statistically significant differences in all variables during the final assessment period, indicative of an effective treatment with sustained activity. The results from pulmonary function testing confirm that the effect of nedocromil sodium was not purely subjective. Assessment over the four- and eight-week periods has shown that nedocromil sodium was able to substitute for two-thirds of the oral bronchodilator and maintain the improvement in the patients asthma status. We found that nedocromil sodium was well tolerated by the patients. The reporting of minor and unusual symptoms was similar in both the placebo and nedocromil sodium groups with the exception of transient bad taste; a phenomenon already reported in the literature. No clinically significant treatment effects were seen in any of the laboratory variables measured. The values for triglyceride, although defined as clinically abnormal, are more likely a reflection of the patients’ prandial state and not an association with the study asthma treatments.