A Double-Blind Multicenter Group Comparative Study of the Efficacy and Safety of Nedocromil Sodium in the Management of Asthma: Results (3)

Although concomitant medication use (Fig 3) was not statistically significantly different (p = 0.34) between treatment groups during the baseline, the nedocromil sodium patients used more SRT (one half unit dose per day). The j$2 use was virtually the same for both groups, with approximately 70 percent of the total daily dose taken during the day. This division into day and night-time use remained constant for both treatment groups throughout the study. Bronchodilator use decreased by the equivalent of one puff fi2 plus one quarter unit dose SRT during weeks 1 to 2 in the nedocromil sodium group. The requirements of the placebo group did not change from baseline. ventolin inhaler

This difference between treatments was statistically significant (p = 0.01). Withdrawal of SRT did not cause a corresponding increase in p2 use in either treatment group. During weeks 3 to 6, the use of IRT in the nedocromil sodium group was approximately one unit dose, reducing to less than one unit dose during weeks 7 to 14. Overall, concomitant bronchodilator use decreased throughout the study in the nedocromil sodium group, but decreased only from the point of bronchodilator withdrawal in the placebo group. Theophylline use was reduced to 36 percent of the baseline during weeks 7 to 14 in the nedocromil sodium group, compared with 57 percent of the baseline in the placebo-treated group.

Figure_3

Figure 3. Concomitant bronchodilator usage score. Mean usage for baseline and treatment weeks 1 to 2, 3 to 6, 7 to 14. Times of bronchodilator withdrawal: SRT after weeks 1 to 2 and oral 02 after weeks 3 to 6. Left-hand column for each period = nedocromil sodium. Right-hand column = placebo. Lower portion of each column = inhaled (J2. Upper portion (baseline, weeks 1 to 2) = SRT. (weeks 3 to 6 and 7 to 14) = IRT. There was one period with a statistically significant (p = 0.01) between treatment difference— weeks 1 to 2. The p-value is based on the nonparametric stratified randomization covariance analysis. Error bars indicate standard error of the mean.

Category: Pulmonary function

Tags: asthma, bronchodilator, nedocromil sodium, pulmonary function