Long-term study of fluticasone propionate aqueous nasal spray in acute and maintenance therapy of nasal polyposis

Topical steroids are first-line medication to control nasal polyposis (NP), a disease with long-term clinical course. The aim of this study was to evaluate the efficacy and safety of fluticasone propionate aqueous nasal spray (FPANS) 200 mu g twice a day (bd) after 1 month of treatment, and to compare FPANS 200 mu g bd and FPANS 200 mu g once a day (od) in maintenance and long-term treatment. Double-blind, placebo-controlled, 8-month study with three treatment periods (1-month acute period followed with 1-month maintenance period and 6-month follow-up period) was carried out. Group 1 received FPANS 200 mu g bd, during acute, maintenance and follow-up periods, Group 2 received FPANS 200 mu g bd during acute period and FPANS 200 mu g od during maintenance and follow-up periods, and Group 3 received placebo during acute and maintenance periods and FPANS 200 mu g bd during follow-up period. Endpoints were change from baseline in clinic peak nasal inspiratory flow (PNIF), domiciliary evening PNIF, intensity of symptoms and polyposis grade. After acute period and maintenance periods, FPANS 200 mu g bd was significantly more effective than placebo on all endpoints and more effective than FPANS 200 mu g od after 1-month maintenance period on clinic PNIF, evening PNIF, obstruction, percentage of days with no sense of smell and percentage of nights with no disturbances. The two doses were similar on other endpoints. After the 6-month follow-up period, there was no difference between the two doses of FPANS at all efficacy endpoints. The safety profile of FPANS did not highlight any new or unanticipated adverse events. The study demonstrated the efficacy of FPANS 200 mu g bd in acute treatment and FPANS 200 mu g od as a sufficient dose to maintain a long-term efficacy in the treatment for NP.