A Study of the Effectiveness and Safety of High Dose, Short-Course Levofloxacin in the Treatment of Acute Bacterial Exacerbation (Worsening) of Chronic Bronchitis.
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bronchitis; Chronic Bronchitis
Intervention: levofloxacin, azithromycin, amoxicillin/clavulanate (Drug)
Phase: Phase 3
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study Director, Affiliation: 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 design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Clinical response rates based on signs and symptoms at posttherapy visit.
Secondary outcome: Microbiologic eradication rates at posttherapy visit
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.
Minimum age: 18 Years.
Maximum age: N/A.
- 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
- Diagnosis of bronchial asthma
- Allergy or serious adverse reaction to any of the study medications or other
- 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
Locations and Contacts
Starting date: November 2001
Ending date: August 2003
Last updated: October 11, 2007