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BAY12-8039: 5 Days for Sinusitis vs Placebo

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ClinicalTrials.gov Identifier: NCT00492024
Recruitment Status : Completed
First Posted : June 27, 2007
Results First Posted : December 2, 2009
Last Update Posted : November 26, 2013
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sinusitis Drug: Moxifloxacin (Avelox, BAY12-8039) Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 374 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2005
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Moxifloxacin 400 mg
Moxifloxacin 400mg once daily for 5 days
 Drug: Moxifloxacin (Avelox, BAY12-8039)
Moxifloxacin - 400 mg once a day for 5 days
Placebo Comparator: Placebo
Matching placebo for 5 days
 Drug: Placebo
Placebo - 380 mg Microcrystalline Cellulose


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Subjects With Clinical Cure (Modified Intent-to-Treat (MITT)) [ Time Frame: 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 :
  1. Treatment Day When Patients Reached Symptom Improvement as Measured by Patient Reported Data, Using Last Observation Carried Forward (LOCF) Approach [ Time Frame: 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.

  2. Treatment Day When Patients Returned to Normal Activities as Measured by Patient Reported Data, Using LOCF Approach [ Time Frame: 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.

  3. Percentage of Subjects With Clinical Improvement During Therapy [ Time Frame: 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.

  4. Percentage of Subjects With Continued Clinical Cure During Long-Term Follow-Up [ Time Frame: 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.


Other Outcome Measures:
  1. Percentage of Subjects With Clinical Cure (Per Protocol Population (PP)) [ Time Frame: At 'Test-of-Cure', 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00492024


Locations
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Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Publications of Results:

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00492024    
Other Study ID Numbers: 11566
First Posted: June 27, 2007    Key Record Dates
Results First Posted: December 2, 2009
Last Update Posted: November 26, 2013
Last Verified: November 2013
Keywords provided by Bayer:
Respiratory Tract Infection
Bacterial Sinusitis
Additional relevant MeSH terms:
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Sinusitis
Respiratory Tract Infections
Infections
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
 Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female