The Study of Nasonex® Compared With Placebo for the Relief of Symptoms Associated With Acute Bacterial Sinusitis When Used With Antibiotics (Study P04824AM3)

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Sinusitis

Intervention / Treatment
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* Drug: MFNS and antibiotic
* Drug: Matching Placebo nasal spray plus antibiotic


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MFNS + Antibiotic<br>Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic. Appropriate antibiotic therapy amoxicillin/clavulanic acid BID. | Drug: MFNS and antibiotic<br>* MFNS BID for 29 days plus amoxicillin/clavulanic acid BID for 10 days<br>* Other names: Group 1: MFNS + Antibiotic;|
| Placebo Comparator: Placebo<br>Matching placebo nasal spray BID for 29 days, plus amoxicillin/clavulanic acid BID | Drug: Matching Placebo nasal spray plus antibiotic<br>* Matching placebo nasal spray BID for 29 days plus amoxicillin/clavulanic acid BID for 10 days<br>* Other names: Group 2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Change in AM/PM PRIOR Major Symptoms Score (Mss) Minus Sinus Headache Averaged Over Days 1 to 29. | The least squares mean decrease from Baseline in AM/PM PRIOR MSS, excluding sinus headache, averaged over Days 1 to 29. PRIOR is the subject's status over the previous 12 hours (reflective). The MSS was defined as the sum of the following subject-evaluated symptoms: facial pain/pressure/tenderness, sinus headache, purulent rhinorrhea, post-nasal drip, and nasal stuffiness/congestion.MSS scores are as follows: 0=none, 1=mild, 2=moderate, 3=severe for each individual symptom. | 29-day Treatment Period and 2-week no-treatment Follow-up Period. | 
| Change From Baseline to Endpoint in Percent of Opacification of the Maxillary Sinus That Had the Maximum Opacification Score at Baseline | A coronal computerized tomography was obtained to visulaize all nasal sinuses and the ostiomeatal complex. Opacification was measured as a percentage of the area of the sinus that was occupied by either fluid or mucosal thickening. The change in percentage of opacification of one maxillary sinus (the one with the highest percentage of opacification) as compared to antibiotic treatment alone. The percentage of opacification was measured and the change from baseline for that percentage was reported. | 29-day Treatment Period and 2-week no-treatment Follow-up Period. |