Effectiveness and Safety of Once or Twice Daily Mometasone Nasal Spray Versus Amoxicillin Versus Placebo for Treatment of Acute Rhinosinusitis (Study P02683)

Efficacy and Safety of 200 mcg QD or 200 mcg BID Mometasone Furoate Nasal Spray (MFNS) vs Amoxicillin vs Placebo as Primary Treatment of Subjects With Acute Rhinosinusitis

This study was conducted to compare the effectiveness and safety of mometasone nasal spray once daily or twice daily with amoxicillin or with placebo in treating the signs and symptoms of acute rhinosinusitis. Patients received mometasone nasal spray 2 sprays per nostril once daily, 2 sprays per nostril twice daily, amoxicillin 500 mg three times a day, or placebo three times a day. Patients on nasal spray were treated for 15 days and patients on amoxicillin or placebo were treated for 10 days. All patients were followed-up with a 14-day no-treatment observation period.

Study Overview

• Status: Completed
• Conditions: Acute Rhinosinusitis
• Intervention / Treatment: Drug: mometasone furoate nasal spray (MFNS); Drug: MFNS; Drug: Amoxicillin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 981
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Subjects must:

• have been diagnosed with acute rhinosinusitis
• have had signs and symptoms of rhinosinusitis for at least 7 but not more than 28 days prior to Baseline
• have had a major symptom score >=5 and <=12 at the Screening and Baseline, and no more than 3 of the 5 major individual symptoms were to be rated as "severe"
• be >=12 years old
• be in good health overall and normal laboratory tests
• not be pregnant, intending to become pregnant or intending to impregnate.

Exclusion Criteria:

Subjects who:

• have a history of chronic rhinosinusitis or who had undergone sinus or nasal surgery for chronic rhinosinusitis in the 6 months prior to Screening
• have fever >=101°F and/or persistent severe unilateral facial pain/tooth pain; and/or orbital or peri-orbital facial swelling; and/or dental involvement; and/or worsening symptoms after initial improvement
• have a history of symptomatic seasonal allergic rhinitis who were exposed to allergenic pollens
• have asthma with FEV1<65% of predicted volume in the past 3 months or who have had an exacerbation within the past 30 days
• have nasal polyps, Kartagener's syndrome, and otitis or atrophic rhinitis
• have certain comorbid conditions or contraindications to certain drug therapies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 4; Placebo	Drug: Placebo; Placebo capsule three times daily for 10 days and placebo nasal spray twice daily for 15 days, followed by 14-day no-treatment observation
Active Comparator: 1; MFNS once daily	Drug: mometasone furoate nasal spray (MFNS); Placebo capsules three times daily for 10 days, and MFNS 50 mcg/spray, 2 sprays in each nostril once daily in the morning and placebo nasal spray once daily in the evening for 15 days, followed by 14-day no-treatment observation period; Other Names: SCH 32088; Nasonex
Experimental: 2; MFNS twice daily	Drug: MFNS; Placebo capsules three times daily for 10 days, and MFNS 50 mcg/spray, 2 sprays in each nostril twice daily for 15 days followed by 14-day no-treatment observation period; Other Names: SCH 32088; Nasonex
Active Comparator: 3; Amoxicillin	Drug: Amoxicillin; Amoxicillin 500 mg/capsule, one capsule 3 times a day for 10 days and placebo nasal spray twice daily for 15 days, followed by a 14-day no-treatment observation period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Average AM/PM major-symptom score (sum of rhinorrhea, post nasal drip, nasal congestion/stuffiness, sinus headache, and facial pain/pressure/tenderness on palpation over the paranasal sinuses) over the Treatment Phase of 15 days.	Over 15 days

Secondary Outcome Measures

Outcome Measure	Time Frame
The total-, major-, and individual-symptom scores (for AM, PM, and AM/PM average) by week, and for Days 1-15, and 16-29.	At end of each week, over Days 1-15, and Days 16-29
Time to onset of action in the major-symptom score, defined as the first day active treatment was statistically significantly different from placebo, and sustained thereafter.	Throughout the Treatment Period
Global response between the groups at Visit 4 or the last treatment visit	At Visit 4 or the last treatment visit
Proportion of subjects who were considered by the investigator to be treatment failures, and proportion of subjects who discontinued early due to treatment failure	Throughout the study

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

General Publications

• Meltzer EO, Bachert C, Staudinger H. Treating acute rhinosinusitis: comparing efficacy and safety of mometasone furoate nasal spray, amoxicillin, and placebo. J Allergy Clin Immunol. 2005 Dec;116(6):1289-95. doi: 10.1016/j.jaci.2005.08.044. Epub 2005 Oct 24.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2003
• Primary Completion (Actual): September 1, 2003
• Study Completion (Actual): September 1, 2003

Study Registration Dates

• First Submitted: September 10, 2008
• First Submitted That Met QC Criteria: September 10, 2008
• First Posted (Estimate): September 11, 2008

Study Record Updates

• Last Update Posted (Actual): February 17, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Anti-Infective Agents; Anti-Inflammatory Agents; Dermatologic Agents; Anti-Bacterial Agents; Anti-Allergic Agents; Amoxicillin; Mometasone Furoate
• Other Study ID Numbers: P02683

Plan for Individual participant data (IPD)

Study Data/Documents

1. CSR Synopsis