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

NCT00750750 | Completed Phase 2

• 1 other identifier: P02683
• Study Type: interventional
• Target: 981
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Rhinosinusitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (4)

1

ACTIVE COMPARATOR

MFNS once daily

Drug: mometasone furoate nasal spray (MFNS)

2

EXPERIMENTAL

MFNS twice daily

Drug: MFNS

3

ACTIVE COMPARATOR

Amoxicillin

Drug: Amoxicillin

4

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

mometasone furoate nasal spray (MFNS) DRUG

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

Also known as: SCH 32088, Nasonex

1

MFNS DRUG

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

Also known as: SCH 32088, Nasonex

2

Amoxicillin DRUG

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

3

Placebo DRUG

Placebo capsule three times daily for 10 days and placebo nasal spray twice daily for 15 days, followed by 14-day no-treatment observation

4

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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.

  PMID: 16337461 RESULT

MeSH Terms

Interventions

Mometasone Furoate; Amoxicillin

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2008
• First Posted: September 11, 2008
• Study Start: January 1, 2003
• Primary Completion: September 1, 2003
• Study Completion: September 1, 2003
• Last Updated: August 15, 2024

Record last verified: 2022-02