Chronic Bronchitis Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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