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 - Full Text View

Sponsors and Collaborators:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C. PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00257140

Purpose

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.

Condition	Intervention	Phase
Bronchitis, Chronic Bronchitis	Drug: levofloxacin	Phase II Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Bronchitis

Drug Information available for: Cefaclor Ofloxacin Levofloxacin Ofloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome 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 Outcome 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.

Estimated Enrollment:	380
Study Start Date:	January 1992
Estimated Study Completion Date:	July 1994

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00257140

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

PriCara, Unit of Ortho-McNeil, Inc.

Investigators

Study Director:

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

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

Additional Information:

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 This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Habib MP, Gentry LO, et al. Multicenter, randomized study comparing efficacy and safety of oral levofloxacin and cefaclor in treatment of acute bacterial exacerbations of chronic bronchitis, Infectious Diseases in Clinical Practice 1998;7:101-109

Study ID Numbers:	CR005494
Study First Received:	November 18, 2005
Last Updated:	May 11, 2007
ClinicalTrials.gov Identifier:	NCT00257140 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Bronchitis
respiratory tract infections
chronic bronchitis
quinolones

lung diseases
bronchial diseases
levofloxacin
antibacterial agents

Study placed in the following topic categories:

Acute Disease
Anti-Infective Agents
Bronchial Diseases
Ofloxacin
Anti-Infective Agents, Urinary
Bronchitis, Chronic
Anti-Bacterial Agents

Lung Diseases, Obstructive
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Bronchitis
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Acute Disease
Anti-Infective Agents
Disease Attributes
Molecular Mechanisms of Pharmacological Action
Bronchial Diseases
Ofloxacin
Anti-Infective Agents, Urinary
Enzyme Inhibitors
Renal Agents
Pharmacologic Actions
Bronchitis, Chronic

Anti-Bacterial Agents
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses
Lung Diseases
Bronchitis
Nucleic Acid Synthesis Inhibitors
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on September 11, 2009