A Study of the Effectiveness and Safety of High Dose, Short-course Levofloxacin in the Treatment of Acute Bacterial Exacerbation (Worsening) of Chronic Bronchitis.

April 26, 2010 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
The purpose of this study is to evaluate the safety and effectiveness of four oral antibiotic treatment regimens for bacterial infections in patients with chronic bronchitis. The study goals are to demonstrate that 1) levofloxacin 750 mg once daily for three days is no worse than azithromycin 250 mg twice a day for one day and then 250 mg once a day for four more days, and 2) levofloxacin 750 mg once daily for five days is no worse than amoxicillin/ clavulanate (875/125 mg) twice daily for 10 days.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, double-blind, multicenter treatment study to evaluate the efficacy and safety of high-dose, short-course oral levofloxacin treatment versus treatment with other oral antibiotics in acute bacterial exacerbation of chronic bronchitis (ABECB). This study evaluates the use of high-dose (750 milligrams) and short-course (3 or 5 days) levofloxacin compared with conventional doses and schedules of other effective antibiotics for controlling acute bacterial infections in patients with chronic bronchitis, The study will divide the 700 patients into two groups--one group with less severe (uncomplicated) chronic bronchitis, and one with more severe (complicated) chronic bronchitis. Patients with uncomplicated disease will receive levofloxacin 750 mg once daily for 3 days or azithromycin 250 mg twice a day for 1 day and then 250 mg once a day for 4 more days. Patients with complicated disease will receive levofloxacin 750 mg once daily for 5 days or amoxicillin/ clavulanate (875/125 mg) twice daily for 10 days. All patients will take study medication orally. Effectiveness will be measured by comparing the patient's signs and symptoms present at the Test-of-Cure Visits (study days 13 - 22) with those observed at the Study Entry Visit. Safety will be evaluated throughout the study on the basis of the occurrence and severity of unexpected and undesirable events as well as by laboratory tests and physical examinations. The hypothesis of the study is that a shorter course (3 days) of 750 mg levofloxacin will be at least as effective and well tolerated as azithromycin for 5 days for uncomplicated ABECB, and that 750 mg of levofloxacin for 5 days will be at least as effective and well tolerated as amoxicillin/ clavulanate for 10 days for curing complicated ABECB cases.

Uncomplicated ABECB: Oral doses of levofloxacin 750 mg once daily for 3 days, or azithromycin 250 mg twice daily on day 1, then 250 mg once daily on days 2 - 5. Complicated ABECB: Oral doses of levofloxacin 750 mg once daily for 5 days, or amoxicillin/clavulante 875/125 mg once daily for 10 days.

Study Type

Interventional

Enrollment (Actual)

659

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of chronic bronchitis
  • Diagnosis of Type-1 or Type-2 acute bacterial exacerbation (worsening) of chronic bronchitis (ABECB) with at least the presence of both increased sputum production and increased sputum purulence with evidence of inflammatory cells
  • If female, must be postmenopausal, surgically sterile, or practicing an effective method of birth control

Exclusion Criteria:

  • Diagnosis of bronchial asthma
  • Allergy or serious adverse reaction to any of the study medications or other antibiotics
  • Failed treatment for pneumonia or acute bacterial exacerbation (worsening) of chronic bronchitis ABECB in three months prior to enrollment in the study with any of the study medications or other antibiotics
  • Can not tolerate medication taken by mouth

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clinical response rates based on signs and symptoms at posttherapy visit.

Secondary Outcome Measures

Outcome Measure
Microbiologic eradication rates at posttherapy visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Collaborators

PriCara, Unit of Ortho-McNeil, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Study Completion (Actual)

August 1, 2003

Study Registration Dates

First Submitted

August 5, 2002

First Submitted That Met QC Criteria

August 6, 2002

First Posted (Estimate)

August 7, 2002

Study Record Updates

Last Update Posted (Estimate)

April 28, 2010

Last Update Submitted That Met QC Criteria

April 26, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR002650

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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