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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
This study has been completed.
First Received: December 22, 2005   Last Updated: May 11, 2007   History of Changes
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborator: 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:


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:
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

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 November 30, 2009