Efficacy and safety of mometasone furoate nasal spray in nasal polyposis

Background: Studies have suggested that topical corticosteroids are effective in the treatment of nasal polyps; however, this has yet to be confirmed in a large, robust clinical trial. Objective: To evaluate the efficacy and safety of mometasone furoate nasal spray (MFNS) for nasal polyposis. Methods: A total of 354 subjects with bilateral nasal polyps and clinically significant congestion/obstruction participated in this multinational, randomized, double-blind, placebo-controlled study. Subjects received MFNS 200 mu g once or twice daily or placebo for 4 months. Coprimary endpoints were (1) change from baseline to last assessment in physician-evaluated bilateral polyp grade score and (2) change from baseline averaged over month 1 in subject-assessed nasal congestion/obstruction. ANOVA was used for all efficacy endpoints, except for change in bilateral polyp grade score, for which baseline polyp grade was added as a covariate. Results: Compared with placebo, MFNS 200 mu g administered once or twice daily produced significantly greater reductions in bilateral polyp grade score (P <.001, P =.010, respectively) and congestion/obstruction (P =.001, P <.001), as well as improvement in loss of smell (P <.001, P =.036), anterior rhinorrhea (P <.001 for both), and postnasal drip (P <.001, P =.001) over month 1. MFNS 200 mu g twice daily was superior to MFNS 200 jig once daily in reducing congestion/obstruction (P =.039), and there were more improvers in the MFNS 200 mu g twice daily group (P =.035). MFNS was well tolerated in both groups. Conclusion: MFNS 200 mu g, once or twice daily, was safe and significantly superior to placebo in reducing polyp grade (size and extent) and improving congestion/obstruction and return of sense of smell. MFNS is an effective medical treatment for nasal polyposis and may reduce or delay the need for surgery.