Clinical Trial: A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Acute Symptoms of Chronic Bronchitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Levofloxacin for the Treatment of Acute Exacerbation of Chronic Bronchitis
Brief Summary: This study was performed to confirm that a single 2.0-g dose of azithromycin SR is at least as effective as 7 days of levofloxacin 500 mg/day in adults with acute exacerbation of chronic bronchitis Secondary objectives: To assess safety and the bacteriologic efficacy of both treatment regimens
Detailed Summary:
Sponsor: Pfizer
Current Primary Outcome: sponsor assessment of clinical response in the Clinical Per Protocol population [ Time Frame: Test of Cure (TOC) visit (Day 14-21) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- investigator assessment of clinical response in the Clinical Per Protocol population [ Time Frame: TOC visit ]
- bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population [ Time Frame: TOC visit ]
- sponsor assessment of clinical response in the Clinical Per Protocol population [ Time Frame: Long-Term Follow-Up (LTFU) visit (Day 28-35) ]
- Summary of baseline susceptibilities [ Time Frame: Study Endpoint ]
- adverse events [ Time Frame: Continuous ]
- clinical laboratory tests [ Time Frame: Baseline and EOT visit ]
- sponsor assessment of clinical response in the Clinical Per Protocol population [ Time Frame: End of Treatment (EOT) visit (Day 8-11) ]
- sponsor assessment of clinical response in the remaining study populations [ Time Frame: TOC visit ]
- sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population [ Time Frame: EOT visit and TOC visit ]
Original Secondary Outcome: Same as current
Information By: Pfizer
Dates:
Date Received: March 19, 2008
Date Started: January 2003
Date Completion:
Last Updated: May 12, 2011
Last Verified: May 2011