Added relief in the treatment of acute recurrent sinusitis with adjunctive mometasone furoate nasal spray

doi:10.1067/mai.2000.109056

Journal of Allergy and Clinical Immunology

Volume 106, Issue 4, October 2000, Pages 630-637

https://doi.org/10.1067/mai.2000.109056 Get rights and content

Abstract

Background: Intranasal glucocorticoids are effective in the treatment of allergic rhinitis. Their effectiveness as an anti-inflammatory adjunct in the treatment of acute recurrent sinusitis has not been adequately established in a controlled clinical study. Objective: The purpose of this study was to test the hypothesis that intranasal corticosteroid treatment produces additional relief in the treatment of acute sinusitis with oral antibiotics. Methods: Patients who were 12 years old and older with a history of recurrent sinusitis were treated while experiencing a new episode of acute sinusitis, which was diagnosed by symptoms and confirmed by computed tomography scan of the paranasal sinuses. Patients were treated for 21 days with amoxicillin clavulanate potassium and randomized to receive concurrent mometasone furoate nasal spray (MFNS; Nasonex [400 μg, twice daily]; n = 200 patients) or placebo spray (twice daily; n = 207 patients). Symptom scores for headache, facial pain, congestion, purulent rhinorrhea, postnasal drip, and cough were recorded at baseline and throughout treatment. Results: Baseline symptom scores showed a moderate level of symptom severity comparable in both groups. Patient-recorded twice daily symptom scores showed that adjunctive treatment with MFNS caused a significantly greater decrease in total symptom score (primary efficacy variable) and in individual scores of inflammatory symptoms associated with the obstruction process (headache, congestion, and facial pain) compared with placebo. Symptoms associated with the secretory processes were improved to a lesser degree. Therapy-related local adverse events were not significantly different between groups. Conclusion: The addition of intranasal corticosteroid, MFNS 400 μg twice daily, to antibiotics significantly reduces symptoms of acute sinusitis compared with antibiotic treatment alone. (J Allergy Clin Immunol 2000;106:630-7.)

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).

. Demographic data

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.

^☆☆: *The members of the Nasonex Sinusitis Group are listed in the acknowledgment section.

^★: Reprint requests: Melvyn R. Danzig, PhD, Schering-Plough Research Institute, 2015 Galloping Hill Road, Kenilworth, NJ 07033.

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Asthma, rhinitis, other respiratory diseasesAdded relief in the treatment of acute recurrent sinusitis with adjunctive mometasone furoate nasal spray☆,☆☆,★

Abstract

Section snippets

Study design

Patient Characteristics

Discussion

Acknowledgements

J Allergy Clin Immunol

J Allergy Clin Immunol

J Allergy Clin Immunol

J Allergy Clin Immunol

J Allergy Clin Immunol

J Allergy Clin Immunol

Ann Allergy Asthma Immunol

J Allergy Clin Immunol

J Allergy Clin Immunol

Otolaryngol Head Neck Surg

J Allergy Clin Immunol

J Allergy Clin Immunol

Ann Allergy Asthma Immunol

Asthma, rhinitis, other respiratory diseases
Added relief in the treatment of acute recurrent sinusitis with adjunctive mometasone furoate nasal spray☆,☆☆,★