Efficacy and tolerability of fluticasone propionate nasal drops 400 mu g once daily compared with placebo for the treatment of bilateral polyposis inadults

Background Chronic eosinophilic rhinosinusitis underlies a range of respira tory disorders including nasal polyposis. Surgical and medical methods are used to control polyps, with topical steroids commonly being used for their anti-inflammatory properties. Fluticasone propionate nasal drops (FPND) is a formulation developed specifically for an effective and well tolerated c orticosteroid treatment of nasal polyposis. Objectives To assess efficacy and tolerability of FPND in the treatment of bilateral nasal polyposis in adults. Methods This multicentre, randomized, parallel-group study compared FPND 40 0 mu g once daily (o.d.) with placebo for 12 weeks in adult patients with m ild to moderate bilateral polyposis. The primary efficacy endpoint was visu al assessment of polyp size by the physician at monthly clinic visits. Nasa l blockage, rhinitis, peak nasal inspiratory flow (PNIF), olfactory functio n and requirement for polypectomy were also assessed at visits. The patient s kept diary card records of symptoms, PNIF, and use of rescue antihistamin e. Additional safety data were provided by a 12-week open extension, when a ll patients received FPND 400 mu g o.d. Results After 12 weeks double-blind treatment with FPND (n = 52) or placebo (n = 52), polyp size was reduced in 27% and 16% of patients, respectively; clinical reduction of nasal blockage significantly favoured FPND over plac ebo (55% vs 22%; P = 0.002), and clinic PNIF had increased significantly wi th FPND (by 52 L/min vs -3 L/min for placebo; P < 0.001). Diary card measur ements showed significant benefits of FPND vs placebo for daily PNIF, nasal blockage, rhinitis and use of loratadine rescue medication. Both treatment s were well tolerated and no serious adverse events occurred during randomi zed treatment. Epistaxis was more frequent with FPND than placebo but was g enerally mild and did not result in withdrawals. Mean serum cortisol levels did not change significantly with either treatment. Conclusion This study showed FPND 400 mu g o.d. to be an effective and well tolerated treatment for bilateral nasal polyposis in adults.