BAY12-8039: 5 Days for Sinusitis vs Placebo

Phase 3

Completed

• Conditions: Sinusitis
• Interventions: Drug: Moxifloxacin (Avelox, BAY12-8039); Drug: Placebo

• Registration Number: NCT00492024
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2007-06-26
• Study First Submitted QC: 2007-06-26
• Study First Posted: 2007-06-27
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Results First Submitted: 2009-03-19
• Results First Submitted QC: 2009-10-28
• Results First Posted: 2009-12-02
• Last Update Submitted: 2013-10-31
• Status Verified: 2013-11
• Last Update Posted: 2013-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 374

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moxifloxacin 400 mg	Moxifloxacin (Avelox, BAY12-8039)	Moxifloxacin 400mg once daily for 5 days
Placebo	Placebo	Matching placebo for 5 days

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Clinical Cure (Modified Intent-to-Treat (MITT))	At 'Test-of-Cure' (TOC), Day 1-5 after end of treatment	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.

Secondary Outcome Measures

Name	Time	Method
Treatment Day When Patients Reached Symptom Improvement as Measured by Patient Reported Data, Using Last Observation Carried Forward (LOCF) Approach	Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment)	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.
Treatment Day When Patients Returned to Normal Activities as Measured by Patient Reported Data, Using LOCF Approach	Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment)	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.
Percentage of Subjects With Clinical Improvement During Therapy	Day 3 of treatment	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.
Percentage of Subjects With Continued Clinical Cure During Long-Term Follow-Up	Day 12 to 26 after end of treatment	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.