BAY12-8039: 5 Days for Sinusitis vs Placebo

NCT00492024 | Completed Phase 3 Results

• 1 other identifier: 11566
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 51

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.

Conditions

Sinusitis

Keywords

Respiratory Tract Infection; Bacterial Sinusitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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)

• 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)

• Percentage of Subjects With Clinical Improvement During Therapy

  Day 3 of treatment

• Percentage of Subjects With Continued Clinical Cure During Long-Term Follow-Up

  Day 12 to 26 after end of treatment

Other Outcomes (1)

• Percentage of Subjects With Clinical Cure (Per Protocol Population (PP))

  At 'Test-of-Cure', Day 1-5 after end of treatment

Study Arms (2)

Moxifloxacin 400 mg

EXPERIMENTAL

Moxifloxacin 400mg once daily for 5 days

Drug: Moxifloxacin (Avelox, BAY12-8039)

Placebo

PLACEBO COMPARATOR

Matching placebo for 5 days

Drug: Placebo

Interventions

Moxifloxacin (Avelox, BAY12-8039) DRUG

Moxifloxacin - 400 mg once a day for 5 days

Moxifloxacin 400 mg

Placebo DRUG

Placebo - 380 mg Microcrystalline Cellulose

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (51)

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Birmingham, Alabama, 35209, United States

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Northport, Alabama, 35476, United States

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Jonesboro, Arkansas, 72401, United States

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Little Rock, Arkansas, 72205, United States

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Fresno, California, 93710, United States

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Fresno, California, 93720, United States

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Garden Grove, California, 92840, United States

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Orange, California, 92868, United States

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Roseville, California, 95678, United States

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San Diego, California, 92106, United States

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San Luis Obispo, California, 93405, United States

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Colorado Springs, Colorado, 80909, United States

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Bridgeport, Connecticut, 06606, United States

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Dunnellon, Florida, 34432, United States

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Hialeah, Florida, 33013, United States

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North Miami Beach, Florida, 33179, United States

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Pembroke Pines, Florida, 33024, United States

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Plantation, Florida, 33324, United States

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Atlanta, Georgia, 30310, United States

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Warner Robbins, Georgia, 31093, United States

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Warner Robins, Georgia, 31088, United States

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Louisville, Kentucky, 40207, United States

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Detroit, Michigan, 48202, United States

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Livonia, Michigan, 48152, United States

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Portage, Michigan, 49024, United States

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Butte, Montana, 59701, United States

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Elizabeth, New Jersey, 07202-3672, United States

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Lawrenceville, New Jersey, 08698, United States

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Somerville, New Jersey, 08876, United States

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Rochester, New York, 14618, United States

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Charlotte, North Carolina, 28210, United States

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Raleigh, North Carolina, 27609, United States

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Cincinnati, Ohio, 45241, United States

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Dayton, Ohio, 45406, United States

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Eugene, Oregon, 97404, United States

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Levittown, Pennsylvania, 19056, United States

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Norristown, Pennsylvania, 19401, United States

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Palmyra, Pennsylvania, 17078, United States

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Clarksville, Tennessee, 37043, United States

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Austin, Texas, 78705, United States

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College Station, Texas, 77845, United States

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El Paso, Texas, 79904, United States

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Houston, Texas, 77074, United States

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San Antonio, Texas, 78229, United States

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Salt Lake City, Utah, 84109, United States

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Salt Lake City, Utah, 84121, United States

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West Jordan, Utah, 84084, United States

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West Jordan, Utah, 84088, United States

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Tappahannock, Virginia, 22560, United States

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Bellingham, Washington, 98225, United States

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Greenfield, Wisconsin, 53228, United States

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Related Publications (1)

• 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.

  PMID: 20422704 RESULT

MeSH Terms

Conditions

Sinusitis; Respiratory Tract Infections

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Confounding factors include concomitant medication for symptomatic relief not standardised, TOC visit occured earlier than for other sinusitis studies, response on placebo underestimated and short-term relief provided by the sinus tap.

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2007
• First Posted: June 27, 2007
• Study Start: January 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: November 26, 2013
• Results First Posted: December 2, 2009

Record last verified: 2013-11

Locations

US (51)