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SinusitisPhase 3NCT00492024

BAY12-8039: 5 Days for Sinusitis vs Placebo

A Phase 3 study testing Moxifloxacin (Avelox, BAY12-8039) in people with Sinusitis, run by Bayer at 51 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sinusitis
What is being tested?
Moxifloxacin (Avelox, BAY12-8039)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
374 participants
Where
51 sitesUnited States
Study dates
Jan 2005to Mar 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

51 sites in 1 country.

51 sites in 1 country

United States51 sites

  • Study site

    Atlanta, Georgia, 30310

  • Study site

    Austin, Texas, 78705

  • Study site

    Bellingham, Washington, 98225

  • Study site

    Birmingham, Alabama, 35209

  • Study site

    Bridgeport, Connecticut, 06606

  • Study site

    Butte, Montana, 59701

  • Study site

    Charlotte, North Carolina, 28210

  • Study site

    Cincinnati, Ohio, 45241

  • Study site

    Clarksville, Tennessee, 37043

  • Study site

    College Station, Texas, 77845

  • Study site

    Colorado Springs, Colorado, 80909

  • Study site

    Dayton, Ohio, 45406

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Dunnellon, Florida, 34432

  • Study site

    El Paso, Texas, 79904

  • Study site

    Elizabeth, New Jersey, 07202-3672

  • Study site

    Eugene, Oregon, 97404

  • Study site

    Fresno, California, 93710

  • Study site

    Fresno, California, 93720

  • Study site

    Garden Grove, California, 92840

  • Study site

    Greenfield, Wisconsin, 53228

  • Study site

    Hialeah, Florida, 33013

  • Study site

    Houston, Texas, 77074

  • Study site

    Jonesboro, Arkansas, 72401

  • Study site

    Lawrenceville, New Jersey, 08698

  • Study site

    Levittown, Pennsylvania, 19056

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Livonia, Michigan, 48152

  • Study site

    Louisville, Kentucky, 40207

  • Study site

    Norristown, Pennsylvania, 19401

  • Study site

    North Miami Beach, Florida, 33179

  • Study site

    Northport, Alabama, 35476

  • Study site

    Orange, California, 92868

  • Study site

    Palmyra, Pennsylvania, 17078

  • Study site

    Pembroke Pines, Florida, 33024

  • Study site

    Plantation, Florida, 33324

  • Study site

    Portage, Michigan, 49024

  • Study site

    Raleigh, North Carolina, 27609

  • Study site

    Rochester, New York, 14618

  • Study site

    Roseville, California, 95678

  • Study site

    Salt Lake City, Utah, 84109

  • Study site

    Salt Lake City, Utah, 84121

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Diego, California, 92106

  • Study site

    San Luis Obispo, California, 93405

  • Study site

    Somerville, New Jersey, 08876

  • Study site

    Tappahannock, Virginia, 22560

  • Study site

    Warner Robbins, Georgia, 31093

  • Study site

    Warner Robins, Georgia, 31088

  • Study site

    West Jordan, Utah, 84084

  • Study site

    West Jordan, Utah, 84088

Other trials in United States

About this study

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

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
Being tested
Moxifloxacin (Avelox, BAY12-8039), Placebo
Keywords
Respiratory Tract Infection, Bacterial Sinusitis
Medical subject headings
Sinusitis, Respiratory Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Moxifloxacin (Avelox, BAY12-8039)Drug

    Moxifloxacin - 400 mg once a day for 5 days

  • PlaceboDrug

    Placebo - 380 mg Microcrystalline Cellulose

Study groups in NCT00492024
Study groupRoleWhat they receive
Moxifloxacin 400 mgExperimentalMoxifloxacin 400mg once daily for 5 days
Receives: Drug: Moxifloxacin (Avelox, BAY12-8039)
PlaceboPlacebo comparatorMatching placebo for 5 days
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 'Test-of-Cure' (TOC), Day 1-5 after end of treatment

Secondary outcomes (4)

  1. 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.

    Measured: Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment)

  2. 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.

    Measured: Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment)

  3. 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.

    Measured: Day 3 of treatment

  4. 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.

    Measured: Day 12 to 26 after end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2007 (estimated)
  2. Study startJan 2005
  3. Primary completionMar 2008
  4. Study completionMar 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
374 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00492024
Sponsor's protocol ID
11566
Status last verified
Nov 2013
First submitted
26 Jun 2007
Last updated
26 Nov 2013
Data monitoring committee
No

Publications

  • 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.

    PubMed 20422704

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Moxifloxacin (Avelox, BAY12-8039) in people with Sinusitis, run by Bayer at 51 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects With Clinical Cure (Modified Intent-to-Treat (MITT)) (time frame: At 'Test-of-Cure' (TOC), Day 1-5 after end of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00492024, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2013; AzTrials last refreshed its copy on 26 Oct 2026.

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