Official Title: “A Multicenter, Active-Controlled, Randomized Study to Evaluate the Safety and Efficacy of Oral Levofloxacin Versus Cefaclor in the Treatment of Acute Bacterial Exacerbation of Chronic Bronchitis in Adults”

The purpose of this study is to evaluate the safety and effectiveness of levofloxacin, an antibiotic, compared with cefaclor, another antibiotic, in the treatment of adults with chronic bronchitis experiencing rapid onset of worsening of symptoms caused by bacteria.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

This is a randomized, open-label, parallel group, multicenter study to determine the effectiveness and safety of 488 mg of levofloxacin (once daily by mouth for 5 - 7 days) compared with 250 mg of cefaclor (every 8 hours for 7 - 10 days) in adults with chronic bronchitis experiencing rapid onset of worsening of symptoms caused by bacterial infection.

The study consists of 3 visits: one visit for screening and enrollment, and 2 visits for assessment of safety and effectiveness (one visit on Days 3 - 5 of the study and one visit [post-therapy] 5 - 7 days after the last dose of the study drug). The total duration of patient participation in the study is approximately 2 weeks. Levofloxacin and cefaclor are antibacterial agents used for the treatment of many types of infections, including infections with a rapid onset and brief duration caused by bacteria. The primary assessment of effectiveness in this study is the microbiologic response to treatment (the rate of elimination of disease-causing bacteria, by patient, and by type of bacteria), 5 - 7 days after the last dose of study drug. Safety evaluations (incidence of adverse events, physical examination, laboratory tests) are performed throughout the study. The study hypothesis is that treatment with levofloxacin is at least as effective and as well tolerated as treatment with cefaclor in adult patients with chronic bronchitis experiencing sudden worsening of symptoms caused by bacterial infection.

Levofloxacin 488 mg by mouth once daily for 5 - 7 days, or cefaclor 250 mg by mouth every 8 hours for 7 - 10 days.

Intervention(s) in this Clinical Trial

• Drug: levofloxacin

Primary Measures

• Rate of elimination of disease-causing bacteria, by patient, and by type of bacteria, 5 - 7 days after the last dose of study drug.

Secondary Measures

• Clinical response rate (reduction in signs and symptoms) at post-therapy (5 - 7 days after the last dose of study drug). Incidence of adverse events; changes in physical examination and laboratory tests after treatment with the study drug.

Inclusion Criteria:

• Diagnosis of chronic bronchitis with a rapid onset of worsening of symptoms caused by bacteria
• History of chronic obstructive lung disease (chronic bronchitis and/or emphysema)
• Recent increase in cough
• Change in type of sputum (the mucus produced on coughing) and/or an increase in the production of sputum
• Received previous antibiotic treatment if the previous treatment lasted for 24 hours or less, or if the previous treatment lasted longer than 24 hours but there was no improvement or stabilization of the disease

Exclusion Criteria:

• Illness requiring antibiotic treatment by injection into a vein, beneath the skin, or into a muscle, or has a requirement of an antibiotic medication taken orally in addition to the study drug
• Infection due to bacteria known (prior to the start of the study) to be resistant to the study drug
• Previous allergic or serious adverse reaction to similar antibiotics
• Diagnosis of pneumonia, determined by a chest x-ray at the start of the trial
• - Has cystic fibrosis, seizure disorders, kidney disease, or an unstable psychiatric condition

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Overall Clinical Trial Officials and Contacts

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Study Director Johnson & Johnson Pharmaceutical Research & Development, L.L.C.  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00257140

Study ID Number: CR005494

ClinicalTrials.gov Identifier: NCT00257140

Health Authority: United States: Food and Drug Administration

A study of the safety and effectiveness of levofloxacin compared to cefaclor in the treatment of adults with chronic bronchitis experiencing rapid onset of worsening of symptoms caused by bacteria