Official Title: “Efficacy and Safety of 200mcg BID Mometasone Furoate Nasal Spray (MFNS) Versus Placebo as Adjunctive Treatment to Antibiotics in Relief of Symptoms of Acute Bacterial Sinusitis”

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).

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2009

Intervention(s) in this Clinical Trial

• Drug: MFNS and antibiotic
  • MFNS BID for 29 days plus antibiotic for 10 days
• Drug: Matching Placebo nasal spray plus antibiotic
  • Matching placebo nasal spray BID for 29 days plus antibiotic for 10 days

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Group 1
  • Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic
• Placebo Comparator: Placebo
  • Matching placebo nasal spray BID for 29 days, plus antibiotic

Primary Measures

• Baseline change in AM/PM PRIOR major symptoms score minus sinus headache averaged over Days 1 to 29; change in opacification percentage of one maxillary sinus.
  • Time Frame: 29-day Treatment Period and 2-week no-treatment Follow-up Period.
    Safety Issue?: No

Secondary Measures

• Safety; to be evaluated by vital signs, laboratory test results, and subject reported adverse events.
  • Time Frame: 29-day Treatment Period and 2-week no-treatment Follow-up Period.
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Schering-Plough

Overall Clinical Trial Officials and Contacts

Ariel A Teper, MD Study Director Schering-Plough  

Overall Contact: SP Clinical Trial Registry Call Center 1-888-772-8734 

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00423176

Study ID Number: P04824

ClinicalTrials.gov Identifier: NCT00423176

Health Authority: United States: Food and Drug Administration