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
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
1 other identifier
interventional
485
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 1993
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 1993
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 1994
CompletedFirst Submitted
Initial submission to the registry
December 22, 2005
CompletedFirst Posted
Study publicly available on registry
December 26, 2005
CompletedJune 10, 2011
February 1, 2011
December 22, 2005
June 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical response rate (reduction in signs and symptoms) at post-therapy (5 - 7 days after the last dose of study drug)
Secondary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 22, 2005
First Posted
December 26, 2005
Study Start
August 1, 1993
Study Completion
May 1, 1994
Last Updated
June 10, 2011
Record last verified: 2011-02