A Study of the Safety and Effectiveness of Levofloxacin Compared With Cefaclor in the Treatment of Adults With Chronic Bronchitis Experiencing Rapid Onset of Worsening of Symptoms Caused by Bacteria

Condition(s) targeted: Bronchitis, Chronic; Bronchitis

Intervention: levofloxacin (Drug)

Phase: Phase 2/Phase 3

Status: Completed

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 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.

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

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

Primary outcome: 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 outcome: 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.

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

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

Starting date: January 1992
Ending date: July 1994
Last updated: May 11, 2007