BAY12-8039: 5 Days for Sinusitis vs Placebo

Sinusitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00492024
• Other study ID #: 11566
• Status: Completed
• Phase: Phase 3
• First received: June 26, 2007
• Last updated: October 31, 2013
• Start date: January 2005
• Est. completion date: March 2008

Study information

• Verified date: November 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sinusitis

Intervention

Drug:
• Moxifloxacin (Avelox, BAY12-8039)
Moxifloxacin - 400 mg once a day for 5 days
• Placebo
Placebo - 380 mg Microcrystalline Cellulose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hadley JA, Mösges 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	At 'Test-of-Cure', Day 1-5 after end of treatment	No
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.	At 'Test-of-Cure' (TOC), Day 1-5 after end of treatment	No
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.	Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment)	No
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.	Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment)	No
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.	Day 3 of treatment	No
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.	Day 12 to 26 after end of treatment	No

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