Objective: To evaluate the effect of mometasone furoate on prevention or reduction of nasal polyp relapse and worsening of symptoms after functional endoscopic sinus surgery (FESS).
Design: Randomized, double-blind, placebo-controlled, multicenter study.
Setting: Ten ear, nose, and throat clinics in Sweden.
Patients: Adult subjects with bilateral nasal polyps fulfilling the criteria for surgery who underwent FESS.
Interventions: Two weeks after FESS, subjects were randomized to receive mometasone furoate nasal spray, 200 microg once daily, or placebo.
Main outcome measures: Time to relapse, defined as an increase of 1 point or more on a 0- to 6-point endoscopic polyp scale.
Results: In the per-protocol population (n = 104), median time to relapse was 173 and 61 days for the mometasone and placebo groups, respectively (P = .007; hazard ratio [95% confidence interval], 0.72 [0.55-0.93]). In the intent-to-treat population (n = 159), median time to relapse was greater than 175 days in the mometasone group and 125 days in the placebo group (P = .049; hazard ratio, 0.79 [0.62-0.99]). The most common adverse event was epistaxis, with 6 cases reported in the mometasone group and 3 in the placebo group.
Conclusions: Postoperative use of mometasone furoate, 200 microg once daily, provided a statistically significant longer time to relapse of nasal polyps than did placebo in subjects with bilateral nasal polyposis who had undergone FESS. The ability of mometasone to prevent or prolong the time to relapse among subjects undergoing FESS is important because this may prolong the time to subsequent surgery.
Trial registration: clinicaltrials.gov Identifier: NCT00731185.