A Comparison of Dexamethasone Cipecilate (NS-126C) and Fluticasone Propionate in Perennial Allergic Rhinitis Treatment

Autor: Kohtaro Baba, Akiyoshi Konno, Minoru Okuda, Kimihiro Okubo, Hiroshi Takenaka
Rok vydání: 2010
Předmět:
Zdroj: Practica oto-rhino-laryngologica. Suppl.. 127:1-16
ISSN: 2185-1557
0912-1870
DOI: 10.5631/jibirinsuppl.127.1
Popis: A 2-week randomized double-blind parallel-group comparison study of dexamethasone cipecilate (NS-126C) was conducted to verify efficacy at 400 μg/day QD in these with perennial allergic rhinitis versus fluticasone propionate (FP) nasal solution at 200 μg/day BID and NS-126C placebo. Of the 406 subjects included in the FAS (NS-126C: 162; FP: 161; placebo: 83), changes in total nasal symptom scores for sneezing, rhinorrhea, and nasal congestion as the primary endpoints, were −2.03±1.95 in the NS-126C group and −2.10±1.77 in the FP group, yielding a group difference in change (95% confidence interval) of 0.07 (−0.32 to 0.46). The maximum 95% confidence interval of 0.46 was lower than the predetermined noninferiority margin (Δ=0.6), demonstrating NS-126C noninferiority to FP. Both comparison drugs were superior to placebo (p
Databáze: OpenAIRE