Dose-dependent effects of budesonide aqueous nasal spray on symptoms in a daily nasal allergen challenge model

Background: It has been difficult to demonstrate dose-dependent clinical ef fects of anti-allergic glucocorticosteroid drugs in allergic rhinitis. Objective: To determine dose-dependent effects on rhinitis symptoms of clin ical doses of the glucocorticosteroid budesonide in a standardized daily al lergen challenge model. Methods: Twenty-five patients with seasonal allergic rhinitis were examined outside the pollen season. The highest 256 mug once daily and lowest 64 mu g once daily clinically recommended doses of budesonide aqueous nasal spray and placebo were given in a double-blind, placebo-controlled, randomized, and crossover design with 4 weeks' washout between treatments. After 1 week 's treatment, the patients received individually titrated nasal allergen ch allenges once every morning for 8 days while treatment continued. Nasal sym ptoms were scored in diary cards. Nasal symptoms from the 6th to the 8th ch allenge days were used in the analysis. Results: The provocation model produced clinically relevant, and around the clock well tolerable rhinitis symptoms, suggesting that after several days of repeated allergen challenges, a season-like, transient allergic disease condition had been established. Both 64 mug and 256 mug of budesonide aque ous nasal spray reduced nasal symptoms. Budesonide 64 mug reduced total nas al symptoms scores from 5.19 +/- 0.5 to 4.23 +/- 0.53 (P < .05), and budeso nide 256 <mu>g reduced total nasal symptoms scores to 3.41 +/- 0.51 (P < .0 01). A significant difference in nasal symptoms after challenge between bud esonide aqueous nasal spray 64 <mu>g and 256 mug (P = .03), indicated a dos e-dependent effect. Conclusions: A dose-dependent, symptom-reducing effect of once-daily treatm ent with topical aqueous nasal sprays of budesonide for two weeks was demon strated, suggesting that this model is relevant for assessments of dose-dep endent effects of anti-inflammatory drugs.