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Acta Otolaryngol. 2006 Jun;126(6):606-12.

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

Author information

1
Karolinska University Hospital, Stockholm, Huddinge, Sweden. par.stjarne@karolinska.se

Abstract

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.

PMID:
16720445
DOI:
10.1080/00016480500452566
[Indexed for MEDLINE]

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