INTRANASAL BUDESONIDE AQUEOUS PUMP SPRAY (RHINOCORT(R) AQUA) FOR THE TREATMENT OF SEASONAL ALLERGIC RHINITIS

To determine the relative efficacy, compare the incidence of adverse e vents, and ascertain the systemic glucocorticoid effect of the nasal a pplication of several doses of budesonide, 406 patients with seasonal ragweed-induced allergic rhinitis were randomized in a double-blind, p arallel group design to receive intranasal budesonide aqueous pump spr ay (Rhinocort(R) Aqua) 32 mu g, 64 mu g, 128 mu g, 256 mu g, or placeb o once daily for 4 weeks. A total of 231 adults and 175 children parti cipated in the study conducted at 14 centers in two geographic regions , the Midwest and the Northeast United States, during the 1994 ragweed season. Pollen counts were collected at each site by the Rotorod(TM) method. The primary efficacy parameter was the change from baseline na sal index score (NIS) for the overall study population-defined as the sum of scores for nasal congestion runny nose, and sneezing. The study was powered only to evaluate the overall study population for statist ical significance. Significant differences in NIS were observed in eac h active treatment group compared with placebo (p less than or equal t o 0.003). Compared with placebo, budesonide aqueous spray significantl y reduced individual symptoms of runny nose and sneezing at all doses (p less than or equal to 0.008), and nasal congestion and nasal itchin g at all doses except 64 mu g (p less than or equal to 0.022). In the Midwest pollen belt where the 1994 ragweed season was representative o f a typical pollen season, it was possible to establish a dose-respons e relationship for comparison of budesonide aqueous spray 256 mu g ver sus 32 mu g (p = 0.017). The incidence of adverse events was similar b etween budesonide aqueous-treated and placebo-treated patients. Import antly, there was no effect of budesonide aqueous spray on basal or ACT H-stimulated plasma cortisol levels in either adults or children at th e end of 4 weeks of treatment. Intranasal budesonide aqueous pump spra y, administered once daily, was efficacious and was generally well tol erated in both adults and children with seasonal allergic rhinitis.