Zm. Munk et al., EFFICACY AND SAFETY OF TRIAMCINOLONE ACETONIDE AQUEOUS NASAL SPRAY INPATIENTS WITH SEASONAL ALLERGIC RHINITIS, Annals of allergy, asthma, & immunology, 77(4), 1996, pp. 277-281
Background: In order to accommodate increasing patient preferences, a
new aqueous formulation of triamcinolone acetonide nasal spray was dev
eloped for the relief of symptoms associated with seasonal and perenni
al allergic rhinitis. Objective: This multicenter, randomized, double-
blind study was designed to compare the efficacy and safety of once-da
ily triamcinolone acetonide aqueous nasal spray (220 mu g/day) with pl
acebo in relieving the symptoms of seasonal allergic rhinitis due to r
agweed. Methods: One hundred forty patients received either a once dai
ly 220-mu g dose of triamcinolone acetonide aqueous nasal spray or pla
cebo for 2 weeks. Patients evaluated the severity of seasonal allergic
rhinitis symptoms daily for 2 weeks according to a 4-point scale (0 =
absent, 1 = mild, 2 = moderate, 3 = severe). Physician and patient gl
obal evaluations of overall treatment effectiveness were assessed at t
he end of the treatment period. Results: Patients receiving triamcinol
one acetonide aqueous nasal spray, 220 mu g/day, had significantly (P
< .05) greater improvements in all rhinitis symptoms at weeks 1 and 2
and overall for the 2-week treatment period compared with the placebo
group. A significant (P = .006) improvement in the nasal index occurre
d as early as 12 hours after the first dose of triamcinolone acetonide
aqueous nasal spray. Both patients and physicians reported a greater
overall improvement in symptoms for the triamcinolone acetonide aqueou
s nasal spray group. There were no differences between the two treatme
nt groups in the incidence of adverse events. Conclusions: This study
confirmed that a 220-mu g dose of triamcinolone acetonide aqueous nasa
l spray, administered once daily for 2 weeks, is well tolerated and re
duces effectively the severity of symptoms of seasonal allergic rhinit
is due to ragweed.