Dose-Range Study of Dexamethasone Cipecilate (NS-126C) a Steroid Nasal Spray in Subjects with Perennial Allergic Rhinitis
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概要
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A 2-week randomized placebo-controlled double-blind parallel-group comparison study of dexamethasone cipecilate (NS-126C) was conducted in subjects with perennial allergic rhinitis to determine recommended dosage and administration frequency. Totally 283 subjects were included into FAS analysis populations (placebo:70; 200 μg/day QD:71; 200 μg/day BID:70; 400 μg/day QD:72). The primary efficacy endpoint, decrease in total nasal symptom score, was −1.03, −1.60, and −2.70 in the placebo group, 200 μg/day QD group, and 400 μg/day QD group. A significant dose response (p<0.001) was confirmed. The changes in both of the 200 μg/day QD and 400 μg/day QD groups were superior to the placebo group (p=0.037, p<0.001). A comparison of regimens showed no statistically significant difference in total nasal symptom score change between the 200 μg/day QD and BID groups. Results for the 400 μg/day QD group were superior to the placebo group in all evaluations of sneezing, rhinorrhea, nasal congestion, disturbance of daily activities, amelioration of symptom severity, and overall improvement. Safety examined in all 285 subjects showed no significant differences in the incidence of adverse events or adverse drug reactions among groups. Main adverse drug reactions were local nasal and throat reactions including pharyngolaryngeal pain and irritation of the nasal meatus. Based on these findings for efficacy and safety, the recommended dosage of NS-126C was 400 μg/day once a day for those with allergic rhinitis.
- 耳鼻咽喉科臨床学会の論文
耳鼻咽喉科臨床学会 | 論文
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