BAY12-8039: 5 Days for Sinusitis vs Placebo

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

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 Overview

• Status: Completed
• Conditions: Sinusitis
• Intervention / Treatment: Drug: Moxifloxacin (Avelox, BAY12-8039); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 374
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
    • Northport, Alabama, United States, 35476
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
    • Little Rock, Arkansas, United States, 72205
  • California
    • Fresno, California, United States, 93720
    • Fresno, California, United States, 93710
    • Garden Grove, California, United States, 92840
    • Orange, California, United States, 92868
    • Roseville, California, United States, 95678
    • San Diego, California, United States, 92106
    • San Luis Obispo, California, United States, 93405
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
  • Florida
    • Dunnellon, Florida, United States, 34432
    • Hialeah, Florida, United States, 33013
    • North Miami Beach, Florida, United States, 33179
    • Pembroke Pines, Florida, United States, 33024
    • Plantation, Florida, United States, 33324
  • Georgia
    • Atlanta, Georgia, United States, 30310
    • Warner Robbins, Georgia, United States, 31093
    • Warner Robins, Georgia, United States, 31088
  • Kentucky
    • Louisville, Kentucky, United States, 40207
  • Michigan
    • Detroit, Michigan, United States, 48202
    • Livonia, Michigan, United States, 48152
    • Portage, Michigan, United States, 49024
  • Montana
    • Butte, Montana, United States, 59701
  • New Jersey
    • Elizabeth, New Jersey, United States, 07202-3672
    • Lawrenceville, New Jersey, United States, 08698
    • Somerville, New Jersey, United States, 08876
  • New York
    • Rochester, New York, United States, 14618
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
    • Raleigh, North Carolina, United States, 27609
  • Ohio
    • Cincinnati, Ohio, United States, 45241
    • Dayton, Ohio, United States, 45406
  • Oregon
    • Eugene, Oregon, United States, 97404
  • Pennsylvania
    • Levittown, Pennsylvania, United States, 19056
    • Norristown, Pennsylvania, United States, 19401
    • Palmyra, Pennsylvania, United States, 17078
  • Tennessee
    • Clarksville, Tennessee, United States, 37043
  • Texas
    • Austin, Texas, United States, 78705
    • College Station, Texas, United States, 77845
    • El Paso, Texas, United States, 79904
    • Houston, Texas, United States, 77074
    • San Antonio, Texas, United States, 78229
  • Utah
    • Salt Lake City, Utah, United States, 84121
    • Salt Lake City, Utah, United States, 84109
    • West Jordan, Utah, United States, 84088
    • West Jordan, Utah, United States, 84084
  • Virginia
    • Tappahannock, Virginia, United States, 22560
  • Washington
    • Bellingham, Washington, United States, 98225
  • Wisconsin
    • Greenfield, Wisconsin, United States, 53228

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With Clinical Cure (Per Protocol Population (PP))	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', Day 1-5 after end of treatment

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General Publications

• Hadley JA, Mosges R, Desrosiers M, Haverstock D, van Veenhuyzen D, Herman-Gnjidic Z. Moxifloxacin five-day therapy versus placebo in acute bacterial rhinosinusitis. Laryngoscope. 2010 May;120(5):1057-62. doi: 10.1002/lary.20878.

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: June 26, 2007
• First Submitted That Met QC Criteria: June 26, 2007
• First Posted (Estimate): June 27, 2007

Study Record Updates

• Last Update Posted (Estimate): November 26, 2013
• Last Update Submitted That Met QC Criteria: October 31, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Respiratory Tract Infection; Bacterial Sinusitis
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
• Other Study ID Numbers: 11566