BAY12-8039: 5 Days for Sinusitis vs Placebo

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the effectiveness and safety of Avelox in a 5 day treatment of adult patients with acute bacterial sinusitis and to measure the amount of time it takes for symptom relief. Avelox is currently not approved for the 5 day treatment of acute bacterial sinusitis, therefore in this study Avelox is considered an investigational drug. In this study Avelox will be compared to placebo.

Official Title
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Prospective, Multicenter, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Moxifloxacin 400 mg QD for 5 Days Versus Placebo in the Treatment of Acute Bacterial Sinusitis

Conditions
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Sinusitis

Intervention / Treatment
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* Drug: Moxifloxacin (Avelox, BAY12-8039)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must meet all the following criteria at the time of enrollment: Age >/= 18 years Clinical diagnosis of acute bacterial sinusitis with signs and symptoms present for = 7 days but < 28 days as defined by A), radiographic, and B) clinical criteria, as follows: Radiographic Criteria: The presence of one or more of the following on a radiographic paranasal sinus film (Waters' view): - Evidence of air-fluid levels - Opacification Clinical Criteria: The presence of two major symptoms, or the presence of at least one major and one minor symptom as defined in the list below: Major symptoms: - Purulent anterior or posterior nasal discharge - Unilateral facial pain or malar tenderness Minor symptoms: - Frontal headache - Fever (oral = 38.0°C/100.4°F, tympanic = 38.5°C/101.2°F, axillary = 37.5°C/99.5°F) - Culture material obtained by sinus puncture; the aspirated specimen sent for Gram stain, quantitative culture and susceptibility testing prior to initiation of antimicrobial therapy Exclusion Criteria: Subjects with one or more of the following criteria will not be eligible for this study: History of chronic sinusitis defined as greater than four weeks of continuous symptoms (subjects with recurrent acute sinusitis will be included) History of sinus surgery (antral sinus puncture is not considered as a surgery) Any symptoms that suggest the subject's current illness is allergic rhinitis (e.g. repetitive sneezing, itchy nose or eyes, provocation by an allergen) and not acute bacterial sinusitis Known bacteremia, meningitis or infection infiltrating the tissues neighboring the sinuses

Ages Eligible for Study
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Minimum Age: 18 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moxifloxacin 400 mg<br>Moxifloxacin 400mg once daily for 5 days | Drug: Moxifloxacin (Avelox, BAY12-8039)<br>* Moxifloxacin - 400 mg once a day for 5 days<br>|
| Placebo Comparator: Placebo<br>Matching placebo for 5 days | Drug: Placebo<br>* Placebo - 380 mg Microcrystalline Cellulose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Clinical Cure (Modified Intent-to-Treat (MITT)) | The primary efficacy variable was clinical response (CR) at the TOC visit, and was rated as improvement, complete resolution, failure, or indeterminate. Clinical cure, ie, success, was defined as complete resolution or improvement in the signs and symptoms such that no further therapy (antimicrobial, steroid, or irrigation) was required. | At 'Test-of-Cure' (TOC), Day 1-5 after end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Day When Patients Reached Symptom Improvement as Measured by Patient Reported Data, Using Last Observation Carried Forward (LOCF) Approach | The Sino-Nasal Outcome Test (SNOT-16) was used to assess subject-reported time to symptom improvement. Improvement was defined as a decrease of at least 14 units on the test. This difference is the smallest difference that has been identified as beneficial to subjects. | Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment) | 
| Treatment Day When Patients Returned to Normal Activities as Measured by Patient Reported Data, Using LOCF Approach | The Activity Impairment Assessment (AIA) questionnaire was used to assess activity impairment at baseline and time to return to normal activities. The AIA was administered prior to first dose, every 24 hours during treatment, and at the TOC visit. Improvement in the AIA total score was defined as a decrease of at least 3 units. | Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment) | 
| Percentage of Subjects With Clinical Improvement During Therapy | A secondary efficacy variable was clinical response (CR) at the During Therapy visit at day 3 or 4 of treatment. CR was rated as improvement, cure, failure, or indeterminate. Clinical evaluation was based on the presence and severity (mild, moderate, or severe) of several signs and symptoms of acute sinusitis. | Day 3 of treatment | 
| Percentage of Subjects With Continued Clinical Cure During Long-Term Follow-Up | A secondary efficacy variable was clinical response (CR) at the Follow-up visit 17-21 days following the start of treatment. CR was rated as continued cure, failure/relapse, or indeterminate. Clinical evaluation was based on the presence and severity (mild, moderate, or severe) of several signs and symptoms of acute sinusitis. | Day 12 to 26 after end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory Tract Infection, Bacterial Sinusitis