Background Topical corticosteroids are the accepted medical adjunct to surgery in patients suffering from nasal polyposis, Fluticasone propionate (FP) is a potent, topically active corticosteroid which ha, been formulated as nasal drops specifically for the treatment of polyposis. Objectives TO evaluate dose-related efficacy and tolerability of FP nasal drops (FPND) in the treatment of mild to moderate bilateral polyposis: in a double-blind, placebo-controlled, multicentre international study. Methods Adult patients (n = 142) with bilateral nasal polyps were randomized to receive either FPND 400 mu g once daily (o.d.), FPND 400 mu g twice daily (b.i.d.) or placebo for 12 weeks. The majority then entered a further 12 week open period during which all patients received FPND 400 mu g o.d. The primary efficacy endpoint was the physicians' visual assessment of polyp size. Secondary clinical endpoints were nasal blockage and overall rhinitis (0-3 scores), peal; nasal inspiratory flow (PNIF), olfactory function tests, and requirement for polypectomy. The patients also kept twice daily records of symptom scores, peak nasal inspiratory flow (PNIF) and use of rescue medication. Results At the end of the 12 week randomized treatment period. polyp size was reduced significantly by FPND 400 mu g b.i.d. as compared with placebo (P = 0.006). Clinical assessments of nasal blockage and overall rhinitis showed significant improvements at several stages of treatment with both doses of FPND, Clinic PNIF was also improved significantly by both doses of FPND in comparison with placebo, and FPND 400 mu g b.i.d. was significantly more effective than 400 mu g o.d. (P = 0.045). patient diary card scores supported the clinical assessments, Two patients on placebo required polypectomy and all treatments were well tolerated with a similar incidence of adverse events. Conclusion FPND 400 mu g once or twice daily is an effective and well-tolerated treatment for bilateral nasal polyposis.
