NEW FORMULATION OF AQUEOUS FLUNISOLIDE NASAL SPRAY IN THE TREATMENT OF ALLERGIC RHINITIS - COMPARATIVE-ASSESSMENT OF SAFETY, TOLERABILITY, AND EFFICACY

This 6-week, multicenter; double-blind, randomized, placebo-controlled , parallel-group trial compared the safety, efficacy, and tolerability of a new formulation of flunisolide nasal spray with the original for mulation in the treatment of allergic rhinitis due to mountain cedar p ollenosis. It was conducted at three clinical centers in close geograp hic proximity. A total of 216 patients, ranging in age from 14 to 77 y ears (mean, 44 yeats), took at least one dose of study drug and theref ore were evaluable for the safety analysis. A total of 185 patients (8 5%) completed the study, and 136 patients were evaluable for the effic acy analysis. Both formulations of flunisolide were comparable in term s of relief of rhinitis symptoms, and the new flunisolide formulation was better tolerated than the original formulation. Both active formul ations were superior to their respective vehicles (P < 0.001) using mu ltiple measures of allergic rhinitis symptoms relief Use of escape med ication (chlorpheniramine maleate) was significantly (P less than or e qual to 0.034) greater in the placebo group when compared with their r espective active treatment groups. No therapeutic effect was observed with symptoms of allergic conjunctivitis. Significantly Sewer patients who were treated with the new formulation flunisolide reported nasal burning and stinging when compared with the original formulation (P = 0.006). In conclusion, the new formulation showed similar efficacy and improved tolerability in the treatment of allergic rhinitis compared with the original formulation. This new formulation not only offers cl inicians a useful therapeutic addition for the treatment of allergic r hinitis, but may also improve patient compliance.