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

Organon

Status and phase: Completed; Phase 2

Conditions: Acute Rhinosinusitis

Treatments: Drug: Placebo; Drug: MFNS; Drug: mometasone furoate nasal spray (MFNS); Drug: Amoxicillin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00750750

P02683

Details and patient eligibility

About

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.

Enrollment: 981 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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981 participants in 4 patient groups, including a placebo group

1

Active Comparator group

Description:

MFNS once daily

Treatment:

Drug: mometasone furoate nasal spray (MFNS)

2

Experimental group

Description:

MFNS twice daily

Treatment:

Drug: MFNS

3

Active Comparator group

Description:

Amoxicillin

Treatment:

Drug: Amoxicillin

4

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo