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Pär Stjärne, MD, PhD; Petter Olsson, MD; Martin Ålenius, MSc

Arch Otolaryngol Head Neck Surg. 2009;135(3):296-302.

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 µg 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 µg 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

Author Affiliations: Department of Clinical Sciences, Intervention and Technology, Division of Otorhinolaryngology, Karolinska Institutet, Karolinska University Hospital Huddinge, Stockholm, Sweden (Drs Stjärne and Olsson); Centre for Allergy Research, Karolinska Institutet (Drs Stjärne amd Olsson); Schering-Plough AB, Stockholm (Dr Olsson); and Clinfile AB, Karlskrona, Sweden (Mr Ålenius).

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