A Double-Blind Multicenter Group Comparative Study of the Efficacy and Safety of Nedocromil Sodium in the Management of Asthma: Results (1)
Treatment Group Comparability, Compliance and Withdrawals
Analysis of the baseline and disease history data showed close comparability between the treatment groups within and across centers. Across the centers, the placebo group had significantly more female subjects (p = 0.005) and significantly fewer patients receiving immunotherapy (p = 0.03), but there were no significant differences in diary card symptom scores, PEFR, medication use, clinic lung function, or clinic assessments.
Compliance with study treatments and concomitant medication restrictions was very good. One patient used nedocromil sodium on a prn basis for the first ten weeks. Two nedocromil sodium-treated patients used SRT daily during week 6 and weeks 6 to 7 and one placebo-treated patient used SRT during weeks 4 to 6. One placebo-treated patient used albuterol tablets during the study. All five patients have been included in the analyses. Ten patients (nine-placebo) received short courses of steroids and have been assessed as treatment failures. All ten patients continued with the study treatments and provided safety and tolerability data. asthma inhalers
Eleven patients were withdrawn during the treatment period (Table 2), including the four patients who contributed no efficacy data. The three placebo-treated patients who were withdrawn owing to treatment ineffectiveness (Table 2) were assessed as treatment failures.
Table 2—Reasons For Withdrawal From the Study
|Onset of uncontrolled asthma||(1)||(1)|
|Moved from study area||1|