A Phase 3 interventional study of levofloxacin in Bronchitis, Chronic, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-06-10.
Sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Phase 3, Interventional, and Treatment
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.
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
268 studies on the registry are indexed under Bronchitis; 26 are open to participants now.
This study's enrollment of 485 is above the median of 120 across 184 interventional studies indexed under Bronchitis.
Browse Bronchitis studies →Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is the lead sponsor of 458 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Clinical response rate (reduction in signs and symptoms) at post-therapy (5 - 7 days after the last dose of study drug)
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
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This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.