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

Acta Otolaryngol. 2006 Jun;126(6):606-12. doi: 10.1080/00016480500452566.


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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Intranasal
  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Inflammatory Agents / administration & dosage*
  • Anti-Inflammatory Agents / adverse effects
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Drug-Related Side Effects and Adverse Reactions
  • Female
  • Humans
  • Male
  • Middle Aged
  • Mometasone Furoate
  • Nasal Obstruction / drug therapy
  • Nasal Polyps / drug therapy*
  • Pregnadienediols / administration & dosage*
  • Pregnadienediols / adverse effects
  • Quality of Life
  • Treatment Outcome


  • Anti-Inflammatory Agents
  • Pregnadienediols
  • Mometasone Furoate