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Efficacy and safety of mometasone furoate nasal spray in the treatment of chronic rhinosinusitis

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Abstract

Introduction

This study evaluated the efficacy and safety of mometasone furoate nasal spray (MFNS) in patients with chronic sinusitis.

Methods

In this double-blind, placebocontrolled, multicenter, parallel-group study, 60 patients with persistent sinusitis symptoms were randomized to receive either MFNS 200 μg twice daily or placebo, for 16 weeks (112 days). Eventually, 53 patients terminated the study in regular course.

Results

Total Symptom Scores (TSS) in patients receiving MFNS changed by a mean of −7.27 (95% CI −9.71, −4.84), versus −5.35 (95% CI −6.73, −3.96) in the placebo group (P=0.51). MFNS reduced nasal congestion and discharge scores, and improved patients’ olfactory function. There were few side effects. Considerably more patients in the MFNS group were satisfied with the treatment than those who had received placebo (P<0.05). Also, more patients would take the medication again in the event of symptoms, compared with those who had taken placebo (P<0.05). Furthermore, the MFNS patients would recommend it to others.

Conclusion

The positive patient assessment and few side effects are reflected in the efficacy evaluation performed by the physicians. The endoscopic results under MFNS were always numerically more favorable than those under placebo, and the overall difference reached statistical significance (P<0.01). MFNS offers an effective and safe treatment for chronic rhinosinusitis.

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Authors and Affiliations

  1. University of Cologne, Institute of Medical Statistics, Informatics and Epidemiology, Medical Faculty, University at Cologne, 50924, Cologne, Germany

    R. Mösges

  2. University Hospital, Ghent, Belgium

    C. Bachert

  3. Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Münster, Münster, Germany

    C. Rudack

  4. Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Dresden, Dresden, Germany

    B. Hauswald

  5. Rhinologic Center, Wiesbaden, Germany

    L. Klimek

  6. Private Practice, Düren, Germany

    J. Spaeth

  7. Department of Otorhinolaryngology, University Hospital Salzburg, Salzburg, Austria

    G. Rasp

  8. Medical Center, Department of Otorhinolaryngology, Head and Neck Surgery, University of Cologne, Cologne, Germany

    J. Vent

  9. Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim, Mannheim, Germany

    K. Hörmann

Authors
  1. R. Mösges
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  2. C. Bachert
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  3. C. Rudack
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  4. B. Hauswald
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  5. L. Klimek
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  6. J. Spaeth
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  7. G. Rasp
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  8. J. Vent
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  9. K. Hörmann
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Correspondence to R. Mösges.

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Mösges, R., Bachert, C., Rudack, C. et al. Efficacy and safety of mometasone furoate nasal spray in the treatment of chronic rhinosinusitis. Adv Therapy 28, 238–249 (2011). https://doi.org/10.1007/s12325-010-0105-7

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  • DOI: https://doi.org/10.1007/s12325-010-0105-7

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