A Double-Blind Multicenter Group Comparative Study of the Efficacy and Safety of Nedocromil Sodium in the Management of Asthma: Results (2)
Primary Efficacy Variables
The changes in diary card symptom scores were consistent across the centers, with the exception of night-time asthma for treatment weeks 1 to 2 (p = 0.01). The data have been pooled for analysis.
The cumulative daily mean symptom score analysis (Fig 1) showed statistically significant differences in favor of nedocromil sodium from day 1 to 3 (p<0.05) and for each of the following 11 days (p<0.05) with a mean decrease from baseline of 0.5. The individual symptom scores (day and night-time asthma and symptomatic cough) meaned over the same two-week period were significantly (p^0.02) in favor of nedocromil sodium (Fig 2). The withdrawal of SRT, and subsequently, oral (J2, did not cause an increase in daytime asthma and cough symptoms in the nedocromil sodium-treated group, but a levelling-off in the previous improvement. The placebo group scores increased, and the between-treatment differences remained statistically significant (p^0.02) throughout (Fig 2).
Night-time asthma scores during weeks 3 to 6 were significantly (p = 0.03) in favor of nedocromil sodium, although neither treatment compensated immediately for the withdrawal of SRT. Night-time asthma scores for the nedocromil sodium group, however, returned to pre-SRT withdrawal levels (weeks 7 to 14, p = 0.006). flovent inhaler
Figure 1. Change from baseline of day and night-time asthma summary score for weeks 1 to 2. Cumulative mean asthma symptom scores for each day of weeks 1-2. Nedocromil sodium and placebo added to the maintenance regimen at the end of the baseline. Closed circles indicate nedocromil sodium (baseline 3.28); open circles, placebo (baseline 3.13). Statistically significant differences (p<0.05) in favor of nedocromil sodium from day 1 to 3 onwards. Error bars indicate standard error of the mean.
Figure 2. Graphs of daily diary card symptom severity score represented as a mean value for each period of assessment (baseline and treatment weeks 1 to 2, 3 to 6, 7 to 14). Closed circles indicate nedocromil sodium; open circles, placebo, (a) Daytime asthma, overall severity scale 0-5. (b) Night-time asthma, overall severity scale 0-2. NOTE: y-axis scale has been drawn in proportion to daytime asthma and cough scales, (c) Cough; overall severity scale 0-5. NOTE: patients who recorded cough during baseline (active, n = 42; placebo, n = 35) = dashed lines, p-values in inset box. All differences (each treatment period for each diary card variable) are statistically significant in favor of nedocromil sodium. The p-values are based on the nonparametric stratified randomization covariance analysis. Error bars indicate standard error of the mean.