Trial Outcomes & Findings for BAY12-8039: 5 Days for Sinusitis vs Placebo (NCT NCT00492024)
NCT ID: NCT00492024
Last Updated: 2013-11-26
Results Overview
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.
COMPLETED
PHASE3
374 participants
At 'Test-of-Cure' (TOC), Day 1-5 after end of treatment
2013-11-26
Participant Flow
The study was conducted at 37 investigative centers in the United States from January 2005 to March 2008.
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).
Participant milestones
| Measure |
Moxifloxacin 400 mg
Moxifloxacin 400mg once daily for 5 days
|
Placebo
Matching placebo for 5 days
|
|---|---|---|
|
Treatment
STARTED
|
251
|
123
|
|
Treatment
COMPLETED
|
222
|
101
|
|
Treatment
NOT COMPLETED
|
29
|
22
|
|
Follow up
STARTED
|
222
|
101
|
|
Follow up
COMPLETED
|
221
|
99
|
|
Follow up
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Moxifloxacin 400 mg
Moxifloxacin 400mg once daily for 5 days
|
Placebo
Matching placebo for 5 days
|
|---|---|---|
|
Treatment
Adverse Event
|
3
|
1
|
|
Treatment
Lack of Efficacy
|
21
|
20
|
|
Treatment
Lost to Follow-up
|
3
|
1
|
|
Treatment
Withdrawal by Subject
|
2
|
0
|
|
Follow up
Lack of Efficacy
|
0
|
1
|
|
Follow up
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
BAY12-8039: 5 Days for Sinusitis vs Placebo
Baseline characteristics by cohort
| Measure |
Moxifloxacin 400 mg
n=251 Participants
Moxifloxacin 400mg once daily for 5 days
|
Placebo
n=123 Participants
Matching placebo for 5 days
|
Total
n=374 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
40.1 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
40.3 years
STANDARD_DEVIATION 13.0 • n=7 Participants
|
40.2 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
165 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
245 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Causative Organisms Isolated from Pretreatment Specimens at Study Entry
Streptococcus pneumoniae
|
32 participants
n=5 Participants
|
13 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Causative Organisms Isolated from Pretreatment Specimens at Study Entry
Moraxella catarrhalis
|
7 participants
n=5 Participants
|
12 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Causative Organisms Isolated from Pretreatment Specimens at Study Entry
Haemophilus influenzae
|
28 participants
n=5 Participants
|
15 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Causative Organisms Isolated from Pretreatment Specimens at Study Entry
Streptococcus pyogenes
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Causative Organisms Isolated from Pretreatment Specimens at Study Entry
Staphylococcus aureus
|
11 participants
n=5 Participants
|
5 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Causative Organisms Isolated from Pretreatment Specimens at Study Entry
Non causative pathogene
|
66 participants
n=5 Participants
|
32 participants
n=7 Participants
|
98 participants
n=5 Participants
|
|
Causative Organisms Isolated from Pretreatment Specimens at Study Entry
No pathogene growth
|
109 participants
n=5 Participants
|
45 participants
n=7 Participants
|
154 participants
n=5 Participants
|
|
Location of infection
Left
|
82 participants
n=5 Participants
|
37 participants
n=7 Participants
|
119 participants
n=5 Participants
|
|
Location of infection
Right
|
94 participants
n=5 Participants
|
46 participants
n=7 Participants
|
140 participants
n=5 Participants
|
|
Location of infection
Bilateral
|
75 participants
n=5 Participants
|
40 participants
n=7 Participants
|
115 participants
n=5 Participants
|
|
Severity of infection
Moderate
|
153 participants
n=5 Participants
|
72 participants
n=7 Participants
|
225 participants
n=5 Participants
|
|
Severity of infection
Severe
|
90 participants
n=5 Participants
|
49 participants
n=7 Participants
|
139 participants
n=5 Participants
|
|
Severity of infection
Mild
|
8 participants
n=5 Participants
|
2 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Duration of infection
|
13.2 days
STANDARD_DEVIATION 5.4 • n=5 Participants
|
12.7 days
STANDARD_DEVIATION 4.7 • n=7 Participants
|
13.0 days
STANDARD_DEVIATION 5.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: At 'Test-of-Cure' (TOC), Day 1-5 after end of treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Moxifloxacin 400 mg
n=73 Participants
Moxifloxacin 400mg once daily for 5 days
|
Placebo
n=45 Participants
Matching placebo for 5 days
|
|---|---|---|
|
Percentage of Subjects With Clinical Cure (Modified Intent-to-Treat (MITT))
Improvement
|
65.8 Percentage of subjects
|
55.6 Percentage of subjects
|
|
Percentage of Subjects With Clinical Cure (Modified Intent-to-Treat (MITT))
Indeterminate
|
2.7 Percentage of subjects
|
0 Percentage of subjects
|
|
Percentage of Subjects With Clinical Cure (Modified Intent-to-Treat (MITT))
Complete resolution
|
12.3 Percentage of subjects
|
11.1 Percentage of subjects
|
|
Percentage of Subjects With Clinical Cure (Modified Intent-to-Treat (MITT))
Success (Clinical Cure)
|
78.1 Percentage of subjects
|
66.7 Percentage of subjects
|
|
Percentage of Subjects With Clinical Cure (Modified Intent-to-Treat (MITT))
Failure
|
19.2 Percentage of subjects
|
33.3 Percentage of subjects
|
SECONDARY outcome
Timeframe: Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment)Population: 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.
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.
Outcome measures
| Measure |
Moxifloxacin 400 mg
n=73 Participants
Moxifloxacin 400mg once daily for 5 days
|
Placebo
n=45 Participants
Matching placebo for 5 days
|
|---|---|---|
|
Treatment Day When Patients Reached Symptom Improvement as Measured by Patient Reported Data, Using Last Observation Carried Forward (LOCF) Approach
Test-Of-Cure
|
43 participants
|
19 participants
|
|
Treatment Day When Patients Reached Symptom Improvement as Measured by Patient Reported Data, Using Last Observation Carried Forward (LOCF) Approach
Day 2
|
14 participants
|
7 participants
|
|
Treatment Day When Patients Reached Symptom Improvement as Measured by Patient Reported Data, Using Last Observation Carried Forward (LOCF) Approach
Day 3
|
26 participants
|
10 participants
|
|
Treatment Day When Patients Reached Symptom Improvement as Measured by Patient Reported Data, Using Last Observation Carried Forward (LOCF) Approach
Day 4
|
31 participants
|
13 participants
|
|
Treatment Day When Patients Reached Symptom Improvement as Measured by Patient Reported Data, Using Last Observation Carried Forward (LOCF) Approach
Day 5
|
39 participants
|
16 participants
|
SECONDARY outcome
Timeframe: Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment)Population: 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.
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.
Outcome measures
| Measure |
Moxifloxacin 400 mg
n=73 Participants
Moxifloxacin 400mg once daily for 5 days
|
Placebo
n=45 Participants
Matching placebo for 5 days
|
|---|---|---|
|
Treatment Day When Patients Returned to Normal Activities as Measured by Patient Reported Data, Using LOCF Approach
Day 3
|
31 participants
|
17 participants
|
|
Treatment Day When Patients Returned to Normal Activities as Measured by Patient Reported Data, Using LOCF Approach
Day 4
|
35 participants
|
17 participants
|
|
Treatment Day When Patients Returned to Normal Activities as Measured by Patient Reported Data, Using LOCF Approach
Day 2
|
22 participants
|
15 participants
|
|
Treatment Day When Patients Returned to Normal Activities as Measured by Patient Reported Data, Using LOCF Approach
Day 5
|
37 participants
|
19 participants
|
|
Treatment Day When Patients Returned to Normal Activities as Measured by Patient Reported Data, Using LOCF Approach
Test-Of-Cure
|
42 participants
|
22 participants
|
SECONDARY outcome
Timeframe: Day 3 of treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Moxifloxacin 400 mg
n=73 Participants
Moxifloxacin 400mg once daily for 5 days
|
Placebo
n=45 Participants
Matching placebo for 5 days
|
|---|---|---|
|
Percentage of Subjects With Clinical Improvement During Therapy
Improvement
|
84.9 Percentage of subjects
|
73.3 Percentage of subjects
|
|
Percentage of Subjects With Clinical Improvement During Therapy
Indeterminate
|
4.1 Percentage of subjects
|
4.4 Percentage of subjects
|
|
Percentage of Subjects With Clinical Improvement During Therapy
Missing
|
11.0 Percentage of subjects
|
22.2 Percentage of subjects
|
SECONDARY outcome
Timeframe: Day 12 to 26 after end of treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Moxifloxacin 400 mg
n=73 Participants
Moxifloxacin 400mg once daily for 5 days
|
Placebo
n=45 Participants
Matching placebo for 5 days
|
|---|---|---|
|
Percentage of Subjects With Continued Clinical Cure During Long-Term Follow-Up
Combined Clinical Cure
|
73.9 Percentage of subjects
|
57.7 Percentage of subjects
|
|
Percentage of Subjects With Continued Clinical Cure During Long-Term Follow-Up
Clinical Failure / Relapse
|
21.9 Percentage of subjects
|
40.0 Percentage of subjects
|
|
Percentage of Subjects With Continued Clinical Cure During Long-Term Follow-Up
Missing
|
4.1 Percentage of subjects
|
2.2 Percentage of subjects
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At 'Test-of-Cure', Day 1-5 after end of treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Moxifloxacin 400 mg
n=62 Participants
Moxifloxacin 400mg once daily for 5 days
|
Placebo
n=42 Participants
Matching placebo for 5 days
|
|---|---|---|
|
Percentage of Subjects With Clinical Cure (Per Protocol Population (PP))
Success
|
82.3 Percentage of subjects
|
66.7 Percentage of subjects
|
|
Percentage of Subjects With Clinical Cure (Per Protocol Population (PP))
Failure
|
17.7 Percentage of subjects
|
33.3 Percentage of subjects
|
|
Percentage of Subjects With Clinical Cure (Per Protocol Population (PP))
Indeterminate
|
0 Percentage of subjects
|
0 Percentage of subjects
|
|
Percentage of Subjects With Clinical Cure (Per Protocol Population (PP))
Complete resolution
|
11.3 Percentage of subjects
|
9.5 Percentage of subjects
|
|
Percentage of Subjects With Clinical Cure (Per Protocol Population (PP))
Improvement
|
71.0 Percentage of subjects
|
57.1 Percentage of subjects
|
Adverse Events
Moxifloxacin 400 mg
Placebo
Serious adverse events
| Measure |
Moxifloxacin 400 mg
n=251 participants at risk
Moxifloxacin 400mg once daily for 5 days
|
Placebo
n=123 participants at risk
Matching placebo for 5 days
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.40%
1/251
|
0.00%
0/123
|
|
Vascular disorders
Hypertension
|
0.00%
0/251
|
0.81%
1/123
|
Other adverse events
| Measure |
Moxifloxacin 400 mg
n=251 participants at risk
Moxifloxacin 400mg once daily for 5 days
|
Placebo
n=123 participants at risk
Matching placebo for 5 days
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.4%
11/251
|
1.6%
2/123
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
5/251
|
2.4%
3/123
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
3/251
|
2.4%
3/123
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
2.4%
6/251
|
4.9%
6/123
|
|
Nervous system disorders
Headache
|
4.4%
11/251
|
3.3%
4/123
|
|
Nervous system disorders
Dizziness
|
3.6%
9/251
|
0.81%
1/123
|
|
Nervous system disorders
Sinus headache
|
2.4%
6/251
|
1.6%
2/123
|
|
Psychiatric disorders
Insomnia
|
0.80%
2/251
|
3.3%
4/123
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.4%
6/251
|
1.6%
2/123
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60