The Journal of Allergy and Clinical Immunology
Volume 116, Issue 6 , Pages 1275-1281, December 2005

Efficacy and safety of mometasone furoate nasal spray in nasal polyposis

  • Catherine Butkus Small, MD

      Affiliations

    • From Division of Infectious Diseases, New York Medical College
    • Corresponding Author InformationReprint requests: Catherine Butkus Small, MD, Division of Infectious Diseases, Munger Pavilion Rm. 245, Valhalla, NY 10595.
    • ,
  • Jaime Hernandez, MD

      Affiliations

    • Medellin Clinic
    • ,
  • Antonio Reyes, MD

      Affiliations

    • Otorrinolaringologo, Centro Médico Imbanaco, Cali
    • ,
  • Eric Schenkel, MD

      Affiliations

    • Drexel University School of Medicine, Philadelphia
    • ,
  • Angela Damiano, MD

      Affiliations

    • Division of Otolaryngology, New York Medical College
    • ,
  • Paul Stryszak, PhD

      Affiliations

    • Schering-Plough Research Institute, Kenilworth
    • ,
  • Heribert Staudinger, MD

      Affiliations

    • Schering-Plough Research Institute, Kenilworth
    • ,
  • Melvyn Danzig, PhD

      Affiliations

    • Schering-Plough Research Institute, Kenilworth

Received 1 April 2005; received in revised form 28 June 2005; accepted 5 July 2005. published online 27 September 2005.

Valhalla, NY, Medellin and Cali, Colombia, Philadelphia, Pa, and Kenilworth, NJ

Background

Studies have suggested that topical corticosteroids are effective in the treatment of nasal polyps; however, this has yet to be confirmed in a large, robust clinical trial.

Objective

To evaluate the efficacy and safety of mometasone furoate nasal spray (MFNS) for nasal polyposis.

Methods

A total of 354 subjects with bilateral nasal polyps and clinically significant congestion/obstruction participated in this multinational, randomized, double-blind, placebo-controlled study. Subjects received MFNS 200 μg once or twice daily or placebo for 4 months. Coprimary endpoints were (1) change from baseline to last assessment in physician-evaluated bilateral polyp grade score and (2) change from baseline averaged over month 1 in subject-assessed nasal congestion/obstruction. ANOVA was used for all efficacy endpoints, except for change in bilateral polyp grade score, for which baseline polyp grade was added as a covariate.

Results

Compared with placebo, MFNS 200 μg administered once or twice daily produced significantly greater reductions in bilateral polyp grade score (P < .001, P = .010, respectively) and congestion/obstruction (P = .001, P < .001), as well as improvement in loss of smell (P < .001, P = .036), anterior rhinorrhea (P < .001 for both), and postnasal drip (P < .001, P = .001) over month 1. MFNS 200 μg twice daily was superior to MFNS 200 μg once daily in reducing congestion/obstruction (P = .039), and there were more improvers in the MFNS 200 μg twice daily group (P = .035). MFNS was well tolerated in both groups.

Conclusion

MFNS 200 μg, once or twice daily, was safe and significantly superior to placebo in reducing polyp grade (size and extent) and improving congestion/obstruction and return of sense of smell. MFNS is an effective medical treatment for nasal polyposis and may reduce or delay the need for surgery.

Key words: Congestion, corticosteroid, clinical trial, intranasal, mometasone furoate, nasal polyps

Abbreviations used: ANCOVA, Analysis of covariance, BID, Twice daily, LS, Least squares, MFNS, Mometasone furoate nasal spray, PNIF, Peak nasal inspiratory flow, QD, Once daily

 

 Supported by a grant from the Schering-Plough Research Institute.Disclosure of potential conflict of interest: Dr Small received research support from PO 1998 SAR Study, PO 1925 Polyp Study, PO 2573 Follow-Up to Polyp Study, PO 2683 Acute Rhinosinusitis, and PO 2692 Acute Rhinosinusitis. Dr Stryszak, Dr Staudinger, and Dr Danzig are employed by Schering-Plough. Dr Schenkel has consultant arrangements with Schering-Plough and Sanofi-Aventis; receives research support from Schering-Plough, Sanofi-Aventis, and Glaxo; and is on the speakers bureau for Schering-Plough, Sanofi-Aventis, and Glaxo. All other authors have no conflict of interest to disclose.

PII: S0091-6749(05)01712-4

doi:10.1016/j.jaci.2005.07.027

The Journal of Allergy and Clinical Immunology
Volume 116, Issue 6 , Pages 1275-1281, December 2005

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