Clinical pharmacology study of the corticosteroid nasal spray dexamethasone cipecilate (NS-126): examination of the durability of efficacy in the nasal induction test.
BACKGROUND
Dexamethasone cipecilate is a corticosteroid nasal spray whose local efficacy durability has been improved by introduction of a liposoluble functional group to its chemical structure. This study was conducted to evaluate the efficacy of once-daily treatment with this drug in patients with perennial allergic rhinitis by a challenge test with house dust antigen (Phase I clinical pharmacology study).


METHODS
This study was designed as a randomised placebo-controlled double-blind study in 28 patients with perennial allergic rhinitis. Either 200 μg dexamethasone cipecilate or placebo was administered once daily for 7 days, and the antigen challenge test conducted 23 h after the dose on each day. We evaluated the efficacy primarily through assessment of suppression of immediate nasal symptoms.


RESULTS
When efficacy durability was evaluated by physicians based on a general assessment of the effects of suppression of nasal symptoms, the percentage of patients with efficacy lasting for 24 h differed significantly between the dexamethasone cipecilate group (69.2%, 9 out of 13) and the placebo group (15.4%, 2 out of 13) (p = 0.015).


CONCLUSIONS
Dexamethasone cipecilate was shown to be a corticosteroid having sustainable local efficacy. The results suggest that once-daily administration of dexamethasone cipecilate is effective in patients with allergic rhinitis, and that its efficacy lasts for 24 h.
Nippon Medical School, Department of Otorhinolaryngology, 1-1-5 Sendagi Bunkyo-ku, Tokyo 113-8603, Japan. m.gotoh@nms.ac.jp
Minoru
M
Gotoh
Kimihiro
K
Okubo
Minoru
M
Okuda
Chikuma
C
Hamada
D000281:Administration, Intranasal; D000328:Adult; D001985:Bronchial Provocation Tests / Q000379:methods*; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008875:Middle Aged; D059085:Nasal Sprays; D011282:Pregnenediones / Q000008:administration & dosage* / Q000737:chemistry; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy* / Q000276:immunology; D055815:Young Adult
C552085:9-fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione 21-cyclohexanecarboxylate 17-cyclopropanecarboxylate; D059085:Nasal Sprays; D011282:Pregnenediones