TRIAMCINOLONE ACETONIDE AQUEOUS NASAL SPRAY IN PATIENTS WITH SEASONALRAGWEED ALLERGIC RHINITIS - A PLACEBO-CONTROLLED, DOUBLE-BLIND-STUDY

Because some patients may prefer aqueous nasal sprays and once-daily d osing for relief of seasonal allergic rhinitis symptoms, a new aqueous formulation of triamcinolone acetonide (TAA Aqueous) was developed. W e conducted a randomized, placebo-controlled, double-blind study to co mpare the efficacy and safety of once-daily administration of 220 mu g /d of TAA Aqueous for 1 week, followed by either 220 mu g/d or 110 mu g/d for an additional 2 weeks, with that of placebo in 429 patients wi th seasonal allergic rhinitis. Patients recorded the severity of sympt oms (nasal stuffiness, discharge, sneezing, nasal index [the sum of th e first three variables], nasal itching, and eye symptoms) on daily di ary cards. Patients' and physicians' global evaluations of efficacy we re made at the end of the 3-week study period. Both regimens of TAA Aq ueous significantly improved symptoms compared with placebo at most ti me points. Patients demonstrated significant improvements in nasal sym ptoms as early as the first day of treatment (within 12 to 16 hours ba sed on treatment in the morning and symptom assessment at bedtime). Al though TAA Aqueous 220 mu g/d provided numerically greater reductions in nasal symptoms compared with 110 mu g/d, these differences in effic acy over the last 2 weeks were not statistically significant. The inci dence of adverse effects with both TAA Aqueous regimens was low and co mparable to that of placebo. In summary, during the first week of ther apy, TAA Aqueous 220 mu g/d significantly reduced nasal symptoms. Duri ng the last 2 weeks of therapy, the 110 mu g/d regimen of TAA Aqueous was effective as continued therapy for most patients. Both the 110 mu g/d and 220 mu g/d regimens of TAA Aqueous provided significantly bett er relief of nasal symptoms than did placebo.