The Study of Nasonex® Compared With Placebo for the Relief of Symptoms Associated With Acute Bacterial Sinusitis When Used With Antibiotics (Study P04824AM3)
Condition: Sinusitis
MeSH terms: Sinusitis
Intervention: MFNS and antibiotic; Matching Placebo nasal spray plus antibiotic
Intervention description: MFNS BID for 29 days plus amoxicillin/clavulanic acid BID for 10 days; Matching placebo nasal spray BID for 29 days plus amoxicillin/clavulanic acid BID for 10 days
Intervention MeSH terms: Anti-Bacterial Agents; Antibiotics, Antitubercular
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 237.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of Nasonex® (mometasone
      furoate nasal spray), when used together with an antibiotic, for the relief of symptoms
      associated with acute bacterial sinusitis. Efficacy will be based on both subjective
      (assessment of symptom severity by the patient) and objective measurements (computed
      tomography [CT] imaging of the sinuses).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be 12 years of age and older, of either sex, and of any race.

          -  Must weigh at least 40 kg (88 lb).

          -  Must be willing to give written informed consent and be able to adhere to dose and
             visit schedules.

          -  Must have a clinical diagnosis of acute bacterial sinusitis.

          -  Must be symptomatic at the Screening and Baseline Visits on the basis of subject
             assessments of major symptoms score.

          -  Must have radiographic evidence of sinusitis on CT scans taken at Screening.

          -  Must be in general good health and free of any clinically significant disease (other
             than sinusitis) that would interfere with the study schedule or procedures, or
             compromise the subject's safety.

          -  A subject's clinical laboratory tests (hematology, blood chemistry, and urinalysis),
             vital signs, and electrocardiogram (ECG) recordings must be within normal limits or
             clinically acceptable to the investigator/qualified designee. Any test results that
             are questionable should be referred to the sponsor.

          -  A female subject of child-bearing potential must have a negative serum pregnancy
             (beta-hCG) test at Screening. She must agree to use a medically accepted method of
             contraception throughout the entire study period. Postmenopausal women will be
             exempted from the use of contraception during the study. Documented absence of menses
             for at least 1 year will indicate that a female is postmenopausal. If a pre-menarche
             female subject begins menstruating during the study, a serum pregnancy test must be
             done at the next visit. A female subject of child-bearing potential who is not
             currently sexually active must agree to use a medically accepted method of
             contraception should she become sexually active while participating in the study.

        Exclusion Criteria:

          -  A subject with moderate to severe persistent asthma that requires daily treatment with
             inhaled steroids, or an exacerbation of asthma within the past 30 days.

          -  A history of chronic sinusitis (symptoms lasting greater than 3 months) or having
             undergone sinus or nasal surgery for chronic sinusitis or nasal polyps.

          -  A history of symptomatic seasonal allergic rhinitis and who, during the study period,
             is living in or traveling to locations where the allergen to which he/she is allergic
             is present.

          -  Subject with glaucoma or a history of posterior subcapsular cataracts.

          -  Subject with nasal polyps visible upon physical examination, immotile cilia syndrome,
             immunodeficiency disease, cystic fibrosis, clinically significant cardiovascular
             (including rheumatic heart disease), pulmonary, renal, hepatic, metabolic,
             hematological or neurologic disease that in the investigator's judgment might
             interfere with the evaluation of the therapy, or subjects who are immunocompromised,
             in renal failure, or on dialysis.

          -  Subject fails to observe the medication washout times outlined in the protocol prior
             to Screening.

          -  Subject has an allergy to corticosteroids or penicillins.

          -  Subject has used any investigational drug within 30 days of Screening.

          -  Subject has a concurrent need for antibiotic therapy other than study drug
             (amoxicillin/clavulanic acid).

          -  Subject is anticipating sinus or nasal surgery within the next month.

          -  Subject has been previously randomized into this study.

          -  Subject is part of the staff personnel directly involved with the study or is a family
             member of the investigational study staff involved in the study.