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.
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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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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
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
Last updated: April 26, 2010