The efficacy and safety of once-daily mometasone furoate nasal spray in nasal polyposis: a randomized, double-blind, placebo-controlled study.

Author(s): Stjarne P, Blomgren K, Caye-Thomasen P, Salo S, Soderstrom T

Affiliation(s): Karolinska University Hospital, Stockholm, Huddinge, Sweden. par.stjarne@karolinska.se

Publication date & source: 2006-06, Acta Otolaryngol., 126(6):606-12.

CONCLUSION: In subjects with mild-to-moderate nasal polyposis, treatment with mometasone furoate nasal spray (MFNS) 200 microg once daily (QD) significantly decreases nasal congestion, reduces polyp size, and improves quality of life. OBJECTIVES: To evaluate the efficacy and safety of MFNS, administered QD in the morning, in subjects with mild-to-moderate nasal polyposis. SUBJECTS AND METHODS: This randomized, double-blind, double-dummy, placebo-controlled clinical trial enrolled subjects with mild-to-moderate nasal polyposis at 12 centers in Denmark, Finland, Norway, and Sweden. Inclusion criteria were: age > or = 18 years, a diagnosis of bilateral nasal polyps, and clinically significant nasal congestion. Following a 2-4-week run-in period, subjects were randomized to receive MFNS 200 microg QD or matching placebo for 16 weeks. RESULTS: A total of 298 subjects were randomized to treatment. Of those subjects included in the intent-to-treat efficacy analysis (n = 291), a statistically greater proportion of the MFNS group than the placebo group had improvements in investigator-assessed nasal congestion score between baseline and end point (the primary outcome) (74.3% vs 46.8%; p < 0.001). Significant benefits of MFNS were also seen for secondary end points, including polyp size, sense of smell, peak nasal inspiratory flow, therapeutic improvement, and quality-of-life measures. MFNS was well tolerated, with no unusual or unexpected adverse events.