Tri-nasal triamcinolone acetonide nasal spray 200 and 400 mu g qd versus placebo and nasacort triamcinolone acetonide nasal aerosol 440 mu g qd in patients suffering from seasonal allergic rhinitis during the grass season
R. Rosenthal et al., Tri-nasal triamcinolone acetonide nasal spray 200 and 400 mu g qd versus placebo and nasacort triamcinolone acetonide nasal aerosol 440 mu g qd in patients suffering from seasonal allergic rhinitis during the grass season, AM J RHINOL, 12(6), 1998, pp. 427-433
Tri-Nasal Nasal Spray is an investigational solution of triamcinolone aceto
nide (TAA) currently being evaluated as a treatment for allergic rhinitis.
The safety and efficacy of 200 and 400 mu g once daily doses of Tri-Nasal N
asal Spray, an active control (440 mu g once daily of Nasacort Nasal aeroso
l), and Tri-Nasal Nasal Spray placebo were compared over a 2-week treatment
period in a double-blind (the Nasacort treatment was not blinded), paralle
l design trial. A total of 377 adult patients in 13 centers were enrolled d
uring the grass pollen season. The primary efficacy variable was the weekly
average of the SSI (Symptom Severity index), the sum of daily nasal conges
tion, rhinorrhea, and sneezing severity scores from the patient diary. A to
tal of 355 patients completed the study. All active treatments were signifi
cantly more effective than placebo in relieving nasal symptoms at each trea
tment week. The 400 mu g Tri-Nasal Nasal Spray and Nasacort treatments had
a rapid onset of action, demonstrating significant improvement in the SSI v
ersus placebo by the second day of treatment. Results for the individual na
sal symptoms and other secondary efficacy measures paralleled those of the
primary efficacy variables. Tri-Nasal Nasal Spray and Nasacort were compara
ble in safety, and in treating the nonocular symptoms of seasonal allergic
rhinitis.