Asthma, rhinitis, other respiratory diseasesAdded relief in the treatment of acute recurrent sinusitis with adjunctive mometasone furoate nasal spray☆,☆☆,★
Section snippets
Study design
This study was a 21-day randomized, double-blind, placebo-controlled trial conducted in 29 medical centers. Patients aged 12 years or older who experienced symptoms that characterized acute sinusitis episodes were evaluated for inclusion in the trial. Qualified patients had a history of sinusitis episodes separated by symptom-free periods (at least 2 sinus infections that required antibiotic treatment per year, for at least the past 2 years). There was no required duration of the current acute
Patient Characteristics
A total of 407 patients met evaluation criteria, which included 70% or more compliance in medication usage. The evaluated groups included 200 patients who received MFNS therapy and 207 who received placebo therapy. There were no clinically relevant differences between the treatment groups in demographic characteristics, and baseline symptom data were also comparable between groups (Table I).
Empty Cell Placebo MFNS Sample size (n) 207 200 Age (y; range 12-73)* 40.5 40.2 Male/female (%) 41/59 31/69
Discussion
Our objective was to test the hypothesis that intranasal corticosteroids produce additional relief in the treatment of acute sinusitis. Patients were enrolled with at least moderate levels of symptom severity, and patient-recorded signs and symptoms were used as the primary evaluation parameters.
The study was designed with the expectation that ACP would demonstrate an early effect in the course of treatment and that the anti-inflammatory effect of MFNS would show up slightly later in the course
Acknowledgements
The members of the Nasonex Sinusitis Group are Jeffrey Adelglass, MD, Dallas, Texas; James N. Baraniuk, MD, Washington, DC; William Berger, MD, Mission Viejo, Calif; David Bernstein, MD, Cincinnati, Ohio; Edwin Bronsky, MD, Salt Lake City, Utah; William Busse, MD, Madison, Wis; Michael Wein, MD, Vero Beach, Fla; B. Lauren Charous, MD, Milwaukee, Wis; Albert F. Finn, Jr, MD, North Charleston, SC; Harold B. Kaiser, MD, Minneapolis, Minn; Clement A. Maccia, MD, Warren Township, NJ; Eli O. Meltzer,
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Supported by a grant from the Schering-Plough Research Institute, Kenilworth, NJ.
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*The members of the Nasonex Sinusitis Group are listed in the acknowledgment section.
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Reprint requests: Melvyn R. Danzig, PhD, Schering-Plough Research Institute, 2015 Galloping Hill Road, Kenilworth, NJ 07033.