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Sponsors and Collaborators: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. PriCara, Unit of Ortho-McNeil, Inc. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00269932 |
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 |
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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 |
Estimated Enrollment: | 400 |
Estimated Study Completion Date: | May 1994 |
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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Study ID Numbers: | CR005497 |
Study First Received: | December 22, 2005 |
Last Updated: | May 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00269932 |
Health Authority: | United States: Food and Drug Administration |
chronic bronchitis quinolones Bronchitis bronchial diseases |
levofloxacin respiratory tract infections antibacterial agents lung diseases |
Acute Disease Bronchitis, Chronic Lung Diseases, Obstructive Cefuroxime axetil Cefuroxime Respiratory Tract Diseases |
Respiratory Tract Infections Lung Diseases Ofloxacin Bronchitis Pulmonary Disease, Chronic Obstructive |
Anti-Infective Agents Anti-Bacterial Agents Disease Attributes Pathologic Processes Molecular Mechanisms of Pharmacological Action Bronchial Diseases |
Therapeutic Uses Anti-Infective Agents, Urinary Enzyme Inhibitors Renal Agents Nucleic Acid Synthesis Inhibitors Pharmacologic Actions |