A Double-Blind Multicenter Group Comparative Study of the Efficacy and Safety of Nedocromil Sodium in the Management of Asthma: Results (6)

A Double-Blind Multicenter Group Comparative Study of the Efficacy and Safety of Nedocromil Sodium in the Management of Asthma: Results (6)Figure 5 indicates the changes in FEV, at clinic visits. The changes in FVC and PEFR are given in Table 5. Measurements at all clinic visits showed highly significant between treatment differences (p^O.Ol). Pulmonary function increased from baseline in the nedocromil sodium-treated group and decreased from baseline for the placebo-treated patients at all clinic visits. Mean changes from baseline over the treatment period were +12 percent : — 7 percent (nedocromil sodium :placebo), +5 percent : —9 percent and +6 percent : —9 percent for FEV,, FVC, and PEFR, respectively. buy asthma inhalers

Tolerability and Safety
There was a threefold difference in the number of nedocromil sodium-treated patients who commented on the taste compared with placebo treated patients (Table 6). Eleven patients remarked on the taste of nedocromil sodium almost from the first day of treatment and continued to report this same effect. Only one patient commented that the taste lingered after taking the drug. With the exception of taste, adverse experiences, particularly cough, bronchospasm, and headache were reported with equal frequency. There were no serious adverse experiences attributable to either treatment, and with the exception of one placebo-treated patient who withdrew owing to throat irritation and wheezing, no patient withdrew as a consequence.

Eleven patients (seven nedocromil sodium) had clinically abnormal prestudy triglyceride levels and ten patients (six nedocromil sodium) had clinically abnormal poststudy levels. One nedocromil sodium-treated patient had high prestudy values of serum glutamic-pyruvic transaminase and serum glutamic-oxalacetic transaminase; these fell substantially during the study, resulting in near normal poststudy values. Overall, the data collected for 51 laboratory variables (blood biochemistry [23], hematology [13] and urinalysis [15]) indicated no adverse trends in either treatment group.


Figure 5. Graph of mean FEV, for each clinic visit (end of baseline, week 2, 6, 10, 14). The mean percentage of change from the baseline for each treatment at each time point is displayed about the x-axis. Closed circles (dotted box) indicates nedocromil sodium; open circles and plain box, placebo. All differences are statistically significant in favor of nedocromil sodium : double asterisk is p<0.01; triple asterisk, p<0.001. The p-values are based on the nonparametric stratified randomization covariance analysis. Error bars indicate standard error of the mean.

Table 5—FVC and PEFR for Each Clinic Visit

Time, (Visit Number) NedocromilSodium Placebo Significance,p-value
Forced vital capacity, L: mean ± SEM
Baseline (2) 4.01 ±0.17 3.79 ±0.14 0.32f
Study week:
2 (3) 4.30 ±0.16 3.59 ±0.14 <0.001
6 (4) 4.21 ±0.16 3.50±0.17 <0.001
10 (5) 4.15 ±0.17 3.38 ±0.17 <0.001
14 (6) 4.23±0.15 3.37 ±0.18 <0.001
Peak Expiratory Flow Rate, L/s: mean ±SEM
Baseline (2) 6.71 ±0.31 6.54 ±0.27 0.88f
Study week:
2 (3) 7.27 ±0.32 6.31 ±0.33 <0.01
6 (4) 7.19 ±0.32 5.92 ±0.32 <0.001
10 (5) 6.91 ±0.34 5.76 ±0.36 <0.001
14 (6) 7.04 ±0.31 5.89 ±0.39 0.01

Table 6—Adverse Effects Judged Related to Trial Treatments

Effect Number of Reports, (%)
Nedocromil Sodium, n = 64 Placebo, n = 62
Taste 16 (25) 5 (8)
Coughing 5 (8) 6 (10)
Bronchospasm 5(8) 6 (10)
Headache 2 (3) 1 (2)
Application site reaction 1 2
Other 9 6

Category: Pulmonary function

Tags: asthma, bronchodilator, nedocromil sodium, pulmonary function