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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Sinusitis
Interventions Drug: Moxifloxacin (Avelox, BAY12-8039)
Drug: Placebo
Enrollment 374
Recruitment Details The study was conducted at 37 investigative centers in the United States from January 2005 to March 2008.
Pre-assignment Details 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).
Arm/Group Title Moxifloxacin 400 mg Placebo
Hide Arm/Group Description Moxifloxacin 400mg once daily for 5 days Matching placebo for 5 days
Period Title: Treatment
Started 251 123
Completed 222 101
Not Completed 29 22
Reason Not Completed
Adverse Event             3             1
Lack of Efficacy             21             20
Lost to Follow-up             3             1
Withdrawal by Subject             2             0
Period Title: Follow up
Started 222 101
Completed 221 99
Not Completed 1 2
Reason Not Completed
Lack of Efficacy             0             1
Lost to Follow-up             1             1
Arm/Group Title Moxifloxacin 400 mg Placebo Total
Hide Arm/Group Description Moxifloxacin 400mg once daily for 5 days Matching placebo for 5 days Total of all reporting groups
Overall Number of Baseline Participants 251 123 374
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 251 participants 123 participants 374 participants
40.1  (13.8) 40.3  (13.0) 40.2  (13.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 251 participants 123 participants 374 participants
Female
165
  65.7%
80
  65.0%
245
  65.5%
Male
86
  34.3%
43
  35.0%
129
  34.5%
Causative Organisms Isolated from Pretreatment Specimens at Study Entry   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 251 participants 123 participants 374 participants
Streptococcus pneumoniae 32 13 45
Moraxella catarrhalis 7 12 19
Haemophilus influenzae 28 15 43
Streptococcus pyogenes 2 2 4
Staphylococcus aureus 11 5 16
Non causative pathogene 66 32 98
No pathogene growth 109 45 154
[1]
Measure Description: Causative organisms identified by pre-therapy sinus puncture (more than one organism was identified for some patients)
Location of infection   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 251 participants 123 participants 374 participants
Left 82 37 119
Right 94 46 140
Bilateral 75 40 115
[1]
Measure Description: Location of sinus infection, left, right, or bilateral
Severity of infection   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 251 participants 123 participants 374 participants
Moderate 153 72 225
Severe 90 49 139
Mild 8 2 10
[1]
Measure Description: Severity of infection as asessed by the investigator
Duration of infection   [1] 
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 251 participants 123 participants 374 participants
13.2  (5.4) 12.7  (4.7) 13.0  (5.1)
[1]
Measure Description: 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.
1.Primary Outcome
Title Percentage of Subjects With Clinical Cure (Modified Intent-to-Treat (MITT))
Hide Description 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.
Time Frame At 'Test-of-Cure' (TOC), Day 1-5 after end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Moxifloxacin 400 mg Placebo
Hide Arm/Group Description:
Moxifloxacin 400mg once daily for 5 days
Matching placebo for 5 days
Overall Number of Participants Analyzed 73 45
Measure Type: Number
Unit of Measure: Percentage of subjects
Success (Clinical Cure) 78.1 66.7
Failure 19.2 33.3
Indeterminate 2.7 0
Complete resolution 12.3 11.1
Improvement 65.8 55.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin 400 mg, Placebo
Comments Null hypothesis is that the success rate for moxifloxacin = the success rate for placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.189
Comments P-value is adjusted for study center; p-value applies to percentage of subjects with success (clinical cure)
Method Cochran-Mantel-Haenszel
Comments Adjusted for study center
2.Secondary Outcome
Title Treatment Day When Patients Reached Symptom Improvement as Measured by Patient Reported Data, Using Last Observation Carried Forward (LOCF) Approach
Hide Description 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.
Time Frame Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Moxifloxacin 400 mg Placebo
Hide Arm/Group Description:
Moxifloxacin 400mg once daily for 5 days
Matching placebo for 5 days
Overall Number of Participants Analyzed 73 45
Measure Type: Number
Unit of Measure: participants
Day 2 14 7
Day 3 26 10
Day 4 31 13
Day 5 39 16
Test-Of-Cure 43 19
3.Secondary Outcome
Title Treatment Day When Patients Returned to Normal Activities as Measured by Patient Reported Data, Using LOCF Approach
Hide Description 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.
Time Frame Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Moxifloxacin 400 mg Placebo
Hide Arm/Group Description:
Moxifloxacin 400mg once daily for 5 days
Matching placebo for 5 days
Overall Number of Participants Analyzed 73 45
Measure Type: Number
Unit of Measure: participants
Day 2 22 15
Day 3 31 17
Day 4 35 17
Day 5 37 19
Test-Of-Cure 42 22
4.Secondary Outcome
Title Percentage of Subjects With Clinical Improvement During Therapy
Hide Description 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.
Time Frame Day 3 of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Moxifloxacin 400 mg Placebo
Hide Arm/Group Description:
Moxifloxacin 400mg once daily for 5 days
Matching placebo for 5 days
Overall Number of Participants Analyzed 73 45
Measure Type: Number
Unit of Measure: Percentage of subjects
Improvement 84.9 73.3
Indeterminate 4.1 4.4
Missing 11.0 22.2
5.Secondary Outcome
Title Percentage of Subjects With Continued Clinical Cure During Long-Term Follow-Up
Hide Description 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.
Time Frame Day 12 to 26 after end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Moxifloxacin 400 mg Placebo
Hide Arm/Group Description:
Moxifloxacin 400mg once daily for 5 days
Matching placebo for 5 days
Overall Number of Participants Analyzed 73 45
Measure Type: Number
Unit of Measure: Percentage of subjects
Combined Clinical Cure 73.9 57.7
Clinical Failure / Relapse 21.9 40.0
Missing 4.1 2.2
6.Other Pre-specified Outcome
Title Percentage of Subjects With Clinical Cure (Per Protocol Population (PP))
Hide Description 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.
Time Frame At 'Test-of-Cure', Day 1-5 after end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Moxifloxacin 400 mg Placebo
Hide Arm/Group Description:
Moxifloxacin 400mg once daily for 5 days
Matching placebo for 5 days
Overall Number of Participants Analyzed 62 42
Measure Type: Number
Unit of Measure: Percentage of subjects
Success 82.3 66.7
Failure 17.7 33.3
Indeterminate 0 0
Complete resolution 11.3 9.5
Improvement 71.0 57.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin 400 mg, Placebo
Comments Null hypothesis is that the success rate for moxifloxacin = the success rate for placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.075
Comments p-value adjusted for study center; p-value applies to percentage of subjects with success (clinical cure)
Method Cochran-Mantel-Haenszel
Comments adjusted for study center
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Moxifloxacin 400 mg Placebo
Hide Arm/Group Description Moxifloxacin 400mg once daily for 5 days Matching placebo for 5 days
All-Cause Mortality
Moxifloxacin 400 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Moxifloxacin 400 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/251 (0.40%)   1/123 (0.81%) 
Infections and infestations     
Pneumonia * 1  1/251 (0.40%)  0/123 (0.00%) 
Vascular disorders     
Hypertension * 1  0/251 (0.00%)  1/123 (0.81%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Moxifloxacin 400 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   49/251 (19.52%)   23/123 (18.70%) 
Gastrointestinal disorders     
Nausea * 1  11/251 (4.38%)  2/123 (1.63%) 
Diarrhoea * 1  5/251 (1.99%)  3/123 (2.44%) 
Vomiting * 1  3/251 (1.20%)  3/123 (2.44%) 
Injury, poisoning and procedural complications     
Procedural Pain * 1  6/251 (2.39%)  6/123 (4.88%) 
Nervous system disorders     
Headache * 1  11/251 (4.38%)  4/123 (3.25%) 
Dizziness * 1  9/251 (3.59%)  1/123 (0.81%) 
Sinus headache * 1  6/251 (2.39%)  2/123 (1.63%) 
Psychiatric disorders     
Insomnia * 1  2/251 (0.80%)  4/123 (3.25%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis * 1  6/251 (2.39%)  2/123 (1.63%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.1
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: BAYER
EMail: clinical-trials-contact@bayerhealthcare.com
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00492024     History of Changes
Other Study ID Numbers: 11566
First Submitted: June 26, 2007
First Posted: June 27, 2007
Results First Submitted: March 19, 2009
Results First Posted: December 2, 2009
Last Update Posted: November 26, 2013