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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
374
Moxifloxacin - 400 mg once a day for 5 days
Placebo - 380 mg Microcrystalline Cellulose
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.
Time frame: At 'Test-of-Cure' (TOC), Day 1-5 after end of treatment
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.
Time frame: 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.
Time frame: 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.
Time frame: Day 3 of treatment
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Unnamed facility
Birmingham, Alabama, United States
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Northport, Alabama, United States
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Jonesboro, Arkansas, United States
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Little Rock, Arkansas, United States
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Fresno, California, United States
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Fresno, California, United States
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Garden Grove, California, United States
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Orange, California, United States
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Roseville, California, United States
Unnamed facility
San Diego, California, United States
...and 41 more locations
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.
Time frame: Day 12 to 26 after end of treatment