BAY12-8039: 5 Days for Sinusitis vs Placebo

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00492024
First received: June 26, 2007
Last updated: October 31, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Sinusitis
Drug: Moxifloxacin (Avelox, BAY12-8039)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 3 of treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 12 to 26 after end of treatment ] [ Designated as safety issue: No ]
    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:
  • Percentage of Subjects With Clinical Cure (Per Protocol Population (PP)) [ Time Frame: At 'Test-of-Cure', Day 1-5 after end of treatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 374
Study Start Date: January 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492024

  Show 51 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00492024     History of Changes
Other Study ID Numbers: 11566
Study First Received: June 26, 2007
Results First Received: March 19, 2009
Last Updated: October 31, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Respiratory Tract Infection
Bacterial Sinusitis

Additional relevant MeSH terms:
Sinusitis
Nose Diseases
Otorhinolaryngologic Diseases
Paranasal Sinus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Combined
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014