A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Cefuroxime Axetil in the Treatment of Adults With Persistent Bronchitis Experiencing Rapid Onset of Severe 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:	NCT00269932

Purpose

The purpose of this study is to evaluate the safety and effectiveness of levofloxacin, an antibiotic, compared with cefuroxime axetil, 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	Drug: levofloxacin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized Study to Compare the Safety and Efficacy of Oral Levofloxacin With That of Cefuroxime Axetil 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: Cefuroxime Cefuroxime sodium Cefuroxime axetil 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:

Clinical response rate (reduction in signs and symptoms) at post-therapy (5 - 7 days after the last dose of study drug)

Secondary Outcome Measures:

Rate of elimination of disease-causing bacteria, by patient, and by type of bacteria; incidence of adverse events; changes in physical examination and laboratory tests after the last dose of study drug

Estimated Enrollment:	400
Estimated Study Completion Date:	May 1994

Detailed Description:

This is a randomized, open-label, parallel group, multicenter study to determine the safety and effectiveness of 500 mg of levofloxacin (once daily for 5

7 days) compared with 250 mg of cefuroxime axetil (every 12 hours for 10 days) in adults with chronic bronchitis experiencing rapid onset of severe worsening of symptoms caused by bacteria. 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. The primary efficacy assessment is the clinical response 5 - 7 days after the last dose of study drug, (categorized as cured, improved, or failed) based upon changes in signs and symptoms. 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 cefuroxime axetil in adult patients with chronic bronchitis experiencing sudden worsening of symptoms caused by bacterial infection.

Levofloxacin 500 mg by mouth once daily for 5 - 7 days, or cefuroxime axetil 250 mg by mouth every 12 hours for 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 obstructive lung disease (chronic bronchitis and/or emphysema) with rapid onset of worsening of symptoms caused by bacterial infection
Recent increase in cough
Change in type or amount of sputum (the mucus produced on coughing)
Findings during the physical examination of clinical signs and symptoms of chronic obstructive lung disease
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 patient has a requirement for a second 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 drugs
Previous allergic or serious adverse reaction to antibiotics similar to the study drugs
Diagnosis of pneumonia determined by 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: NCT00269932

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 taken by mouth compared with cefuroxime axetil in the treatment of adults with persistent bronchitis experiencing rapid onset of severe worsening of symptoms caused by bacteria This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CR005497
Study First Received:	December 22, 2005
Last Updated:	May 11, 2007
ClinicalTrials.gov Identifier:	NCT00269932 History of Changes
Health Authority:	United States: Food and Drug Administration

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

chronic bronchitis
quinolones
Bronchitis
bronchial diseases

levofloxacin
respiratory tract infections
antibacterial agents
lung diseases

Study placed in the following topic categories:

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

Cefuroxime
Cefuroxime axetil
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
Anti-Bacterial Agents
Bronchitis, Chronic

Lung Diseases, Obstructive
Pathologic Processes
Cefuroxime axetil
Cefuroxime
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 July 06, 2009