Efficacy and safety of mometasone furoate nasal spray in nasal polyposis

doi:10.1016/j.jaci.2005.07.027

Journal of Allergy and Clinical Immunology

Volume 116, Issue 6, December 2005, Pages 1275-1281

https://doi.org/10.1016/j.jaci.2005.07.027 Get rights and content

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.

Section snippets

Study design

A randomized, double-blind, double-dummy, placebo-controlled study was carried out in 44 medical centers worldwide in accordance with the Declaration of Helsinki and guidelines on Good Clinical Practices. The study protocol and statement of informed consent were reviewed and approved by an Institutional Review Board and Independent Ethics Committee.

Subjects who met eligibility criteria at the screening visit (day −14, visit 1) underwent a 14-day, single-blind, placebo run-in period to help

Subject disposition and characteristics

A total of 354 subjects were randomized. No clinically relevant differences in demographic characteristics among the 3 treatment groups were observed, with ≤25% of subjects having a history of mild asthma or perennial allergic rhinitis (Table I). Small differences in baseline bilateral polyp grade score were observed between treatment groups, with the majority of subjects having a total bilateral polyp grade score of 4 to 6. More than 90% of subjects had a moderate to severe baseline

Discussion

The objectives of medical therapy for nasal polyposis are to reduce or eliminate polyps, open the nasal airway, improve or restore the sense of smell, and prevent recurrence.9, 10 Although endoscopic sinus surgery has been shown to be effective in reducing polyp size and nasal blockage, at least temporarily,¹⁸ a randomized controlled study evaluating medical treatment (oral and topical corticosteroids) with or without surgical treatment in subjects with symptomatic nasal polyposis found that

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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.

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Rhinitis, sinusitis, and ocular diseasesEfficacy and safety of mometasone furoate nasal spray in nasal polyposis

Background

Objective

Methods

Results

Conclusion

Section snippets

Study design

Subject disposition and characteristics

Discussion

J Allergy Clin Immunol

J Allergy Clin Immunol

Ann Allergy Asthma Immunol

J Allergy Clin Immunol

J Allergy Clin Immunol

J Allergy Clin Immunol

Prevalence of asthma, aspirin intolerance, nasal polyposis and chronic obstructive pulmonary disease in a population-based study

Int J Epidemiol

An update on the diagnosis and treatment of sinusitis and nasal polyposis

Allergy

[Sense of smell before and after endonasal surgery in chronic sinusitis with polyps]

HNO

Superantigens and nasal polyps

Curr Allergy Asthma Rep

Direct demonstration of delayed eosinophil apoptosis as a mechanism causing tissue eosinophilia

J Immunol

Human eotaxin is a specific chemoattractant for eosinophil cells and provides a new mechanism to explain tissue eosinophilia

Nat Med

Eosinophil transendothelial migration induced by cytokines. II. Potentiation of eosinophil transendothelial migration by eosinophil-active cytokines

J Immunol

Rhinitis, sinusitis, and ocular diseases
Efficacy and safety of mometasone furoate nasal spray in nasal polyposis