The Journal of Allergy and Clinical Immunology
Volume 121, Issue 4 , Pages 928-932, April 2008

Onset of symptomatic effect of mometasone furoate nasal spray in the treatment of nasal polyposis

  • Catherine Butkus Small, MD

      Affiliations

    • Division of Infectious Diseases, New York Medical College, Westchester Medical Center, Valhalla, NY
    • Corresponding Author InformationReprint requests: Catherine Butkus Small, MD, Division of Infectious Diseases, Munger Pavilion Rm 245, Valhalla, NY 10595.
  • ,
  • Paul Stryszak, PhD

      Affiliations

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

      Affiliations

    • Schering-Plough Research Institute, Kenilworth, NJ
  • ,
  • Angela Damiano, MD

      Affiliations

    • Division of Otolaryngology, New York Medical College, Westchester Medical Center, Valhalla, NY

Received 23 May 2007; received in revised form 18 October 2007; accepted 12 November 2007. published online 31 January 2008.

Background

The efficacy of the intranasal corticosteroid mometasone furoate nasal spray (MFNS) for treatment of nasal polyposis was demonstrated in 2 large clinical trials.

Objective

To evaluate the onset of MFNS symptomatic effect, data from the 2 trials were pooled and analyzed to determine the first day subjects experienced significant symptom relief.

Methods

Subjects with nasal polyposis randomized to MFNS 200 μg twice daily or placebo scored symptoms on a 3-point scale (0 = none; 3 = severe) and measured peak nasal inspiratory flow immediately before the morning dose. Onset of symptomatic effect was defined as the first day a statistically significant (P < .05) lasting response was observed for MFNS compared with placebo.

Results

A total of 447 subjects with bilateral nasal polyps and clinically significant nasal congestion/obstruction were analyzed. Compared with placebo, MFNS 200 μg twice daily demonstrated statistically significant (P < .05) relief of anterior rhinorrhea by day 2 (–10.9% vs +5.7%), nasal congestion by day 3 (–15.1% vs –7.6%), postnasal drip by day 5 (+1.1% vs +4.6%), and sense of smell by day 13 (–9.6% vs –5.6%). Significant improvement in peak nasal inspiratory flow was seen by day 2 (increase of 6.22 L/min vs 1.48 L/min for placebo; P = .03).

Conclusion

Mometasone furoate nasal spray 200 μg twice daily rapidly improves the symptoms of nasal polyposis, leading to lasting relief of most major symptoms within 2 (24 hours after the first dose) to 5 days of initiating therapy.

Key words: Nasal polyposis, mometasone furoate, efficacy onset, intranasal corticosteroids, clinical trial

Abbreviations used: LS, Least squares, MFNS, Mometasone furoate nasal spray, PNIF, Peak nasal inspiratory flow

 

 Supported by a grant from the Schering-Plough Research Institute.

 Disclosure of potential conflict of interest: P. Stryszak is employed by Schering-Plough. M. Danzig has consulting arrangements with, owns stock in, and was formerly employed by Schering-Plough. The rest of the authors have declared that they have no conflict of interest.

PII: S0091-6749(07)02255-5

doi:10.1016/j.jaci.2007.11.018

The Journal of Allergy and Clinical Immunology
Volume 121, Issue 4 , Pages 928-932, April 2008