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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moxifloxacin 400 mg | Experimental | Moxifloxacin 400mg once daily for 5 days |
|
| Placebo | Placebo Comparator | Matching placebo for 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moxifloxacin (Avelox, BAY12-8039) | Drug | Moxifloxacin - 400 mg once a day for 5 days |
| |
| 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 |
| 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. |
| 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. |
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:
Exclusion Criteria:
Subjects with one or more of the following criteria will not be eligible for this study:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35209 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20422704 | Result | 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. |
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Modified Intent-to-Treat (MITT): Subjects who received at least 1 dose of study drug with a baseline sinus culture positive for at least 1 of 5 common bacteria that cause sinusitis (73 moxifloxacin [M], 45 placebo [P]). Per protocol (PP): Subjects with a positive baseline culture (as above) meeting a long list of additional criteria (62 M, 42 P).
The study was conducted at 37 investigative centers in the United States from January 2005 to March 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Moxifloxacin 400 mg | Moxifloxacin 400mg once daily for 5 days |
| FG001 | Placebo | Matching placebo for 5 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment |
|
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| Placebo |
| Drug |
Placebo - 380 mg Microcrystalline Cellulose |
|
| 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 |
| At 'Test-of-Cure', Day 1-5 after end of treatment |
| Northport |
| Alabama |
| 35476 |
| United States |
| Jonesboro | Arkansas | 72401 | United States |
| Little Rock | Arkansas | 72205 | United States |
| Fresno | California | 93710 | United States |
| Fresno | California | 93720 | United States |
| Garden Grove | California | 92840 | United States |
| Orange | California | 92868 | United States |
| Roseville | California | 95678 | United States |
| San Diego | California | 92106 | United States |
| San Luis Obispo | California | 93405 | United States |
| Colorado Springs | Colorado | 80909 | United States |
| Bridgeport | Connecticut | 06606 | United States |
| Dunnellon | Florida | 34432 | United States |
| Hialeah | Florida | 33013 | United States |
| North Miami Beach | Florida | 33179 | United States |
| Pembroke Pines | Florida | 33024 | United States |
| Plantation | Florida | 33324 | United States |
| Atlanta | Georgia | 30310 | United States |
| Warner Robbins | Georgia | 31093 | United States |
| Warner Robins | Georgia | 31088 | United States |
| Louisville | Kentucky | 40207 | United States |
| Detroit | Michigan | 48202 | United States |
| Livonia | Michigan | 48152 | United States |
| Portage | Michigan | 49024 | United States |
| Butte | Montana | 59701 | United States |
| Elizabeth | New Jersey | 07202-3672 | United States |
| Lawrenceville | New Jersey | 08698 | United States |
| Somerville | New Jersey | 08876 | United States |
| Rochester | New York | 14618 | United States |
| Charlotte | North Carolina | 28210 | United States |
| Raleigh | North Carolina | 27609 | United States |
| Cincinnati | Ohio | 45241 | United States |
| Dayton | Ohio | 45406 | United States |
| Eugene | Oregon | 97404 | United States |
| Levittown | Pennsylvania | 19056 | United States |
| Norristown | Pennsylvania | 19401 | United States |
| Palmyra | Pennsylvania | 17078 | United States |
| Clarksville | Tennessee | 37043 | United States |
| Austin | Texas | 78705 | United States |
| College Station | Texas | 77845 | United States |
| El Paso | Texas | 79904 | United States |
| Houston | Texas | 77074 | United States |
| San Antonio | Texas | 78229 | United States |
| Salt Lake City | Utah | 84109 | United States |
| Salt Lake City | Utah | 84121 | United States |
| West Jordan | Utah | 84084 | United States |
| West Jordan | Utah | 84088 | United States |
| Tappahannock | Virginia | 22560 | United States |
| Bellingham | Washington | 98225 | United States |
| Greenfield | Wisconsin | 53228 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow up |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Moxifloxacin 400 mg | Moxifloxacin 400mg once daily for 5 days |
| BG001 | Placebo | Matching placebo for 5 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Causative Organisms Isolated from Pretreatment Specimens at Study Entry | Causative organisms identified by pre-therapy sinus puncture (more than one organism was identified for some patients) | Number | participants |
| |||||||||||||||
| Location of infection | Location of sinus infection, left, right, or bilateral | Number | participants |
| |||||||||||||||
| Severity of infection | Severity of infection as asessed by the investigator | Number | participants |
| |||||||||||||||
| Duration of infection | Subgroup analyses were performed on subjects with differing durations of infection of 7 to 14 days, 15 to 21 days, and 22 to 27 days. | Mean | Standard Deviation | days |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The modified intent-to-treat (MITT) population was the primary analysis population. This population includes all subjects treated with at least one dose of study medication, and who have at least one pre-treatment causative organism. | Posted | Number | Percentage of subjects | At 'Test-of-Cure' (TOC), Day 1-5 after end of treatment |
|
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The MITT population was the primary analysis population. This population includes all subjects treated with at least one dose of study medication, and who have at least one pre-treatment causative organism. | Posted | Number | participants | Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The MITT population was the primary analysis population. This population includes all subjects treated with at least one dose of study medication, and who have at least one pre-treatment causative organism. | Posted | Number | participants | Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The MITT population was the primary analysis population. This population includes all subjects treated with at least one dose of study medication, and who have at least one pre-treatment causative organism. Missing responses at during therapy visit in most cases was due to early clinical failure. | Posted | Number | Percentage of subjects | Day 3 of treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The MITT population was the primary analysis population. This population includes all subjects treated with at least one dose of study medication, and who have at least one pre-treatment causative organism. | Posted | Number | Percentage of subjects | Day 12 to 26 after end of treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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. | This analysis population was per protocol population, which included all subjects with at least one pre-treatment causative organism, and who had no major deviations from the protocol procedures. | Posted | Number | Percentage of subjects | At 'Test-of-Cure', Day 1-5 after end of treatment |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Moxifloxacin 400 mg | Moxifloxacin 400mg once daily for 5 days | 1 | 251 | 49 | 251 | ||
| EG001 | Placebo | Matching placebo for 5 days | 1 | 123 | 23 | 123 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA 10.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
|
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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D012852 | Sinusitis |
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
|
| Moraxella catarrhalis |
|
| Haemophilus influenzae |
|
| Streptococcus pyogenes |
|
| Staphylococcus aureus |
|
| Non causative pathogene |
|
| No pathogene growth |
|
| Right |
|
| Bilateral |
|
| Severe |
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| Mild |
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| Indeterminate |
|
| Complete resolution |
|
| Improvement |
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