 |
|
A Randomized Controlled Trial of Mometasone Furoate Nasal Spray for the Treatment of Nasal Polyposis
Pär Stjärne, MD, PhD;
Ralph Mösges, MD, PhD;
Mark Jorissen, MD, PhD;
Desiderio Passàli, MD, PhD;
Luisa Bellussi, MD, PhD;
Heribert Staudinger, MD;
Melvyn Danzig, MD
Arch Otolaryngol Head Neck Surg. 2006;132:179-185.
Objective To evaluate the efficacy and safety of mometasone furoate nasal spray (NS) for the treatment of nasal polyposis.
Design Randomized, double-blind, placebo-controlled, parallel-group, multicenter study.
Setting A total of 24 centers in 17 countries.
Patients A total of 310 subjects 18 years or older with bilateral nasal polyps.
Interventions (1) A 200-µg dose of mometasone furoate NS in the morning and matching placebo in the evening; (2) 200-µg doses of mometasone furoate NS in the morning and evening; or (3) matching placebo in the morning and evening. All 3 regimens were administered as a nasal spray for 4 months.
Main Outcome Measures Primary end points were change from baseline to last assessment in physician-assessed bilateral polyp grade and change from baseline in subject-assessed congestion and/or obstruction score averaged over the first month of treatment. Analysis of variance was used for all efficacy end points except for change in bilateral polyp grade, for which baseline polyp grade was added as a covariate to the analysis of variance model to account for any between-group baseline differences in this variable.
Results Mometasone furoate NS doses of 200 µg administered once or twice daily produced greater reductions in bilateral polyp grade at the end point than placebo, with differences reaching statistical significance with twice-daily dosing (P = .04). Over 1 month, both mometasone furoate NS regimens produced statistically superior improvements from baseline in congestion and/or obstruction score vs placebo (P = .01 for once-daily dosing; P<.001 for twice-daily dosing). The drug was well tolerated.
Conclusion Mometasone furoate NS is an effective and well-tolerated treatment for bilateral nasal polyposis in adults, reducing nasal polyp size and symptoms of nasal congestion and/or obstruction.
Author Affiliations: Department of Otorhinolaryngology, Karolinska University Hospital, Stockholm, Sweden (Dr Stjärne); Institute of Medical Statistics, Informatics, and Epidemiology, University of Cologne, Cologne, Germany (Dr Mösges); Department of Otorhinolaryngology–Head and Neck Surgery, University Hospital Leuven, Leuven, Belgium (Dr Jorissen); Department of Otorhinolaryngology, University of Siena, Siena, Italy (Drs Passàli and Bellussi); and Schering-Plough Research Institute, Kenilworth, NJ (Drs Staudinger and Danzig).
|
