Clinical Trial: A Trial To Evaluate Two Antibiotics For The Treatment Of Acute Exacerbation Of Chronic Bronchitis (AECB)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 3B Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial To Evaluate The Efficacy and Safety Of Azithromycin SR (Microspheres Formulation) Versus Moxifloxacin For The Treatment

Brief Summary: This trial is a research drug study to compare the effects of two antibiotics for the treatment of acute exacerbation of chronic bronchitis

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome: Percentage of Clinical Cure (Success) at Test of Cure Visit(Clinical Per Protocol Population) [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ]

Original Primary Outcome: Clinical Response at Test of Cure Visit

Current Secondary Outcome:

  • Percentage of Clinical Cure (Success) at Test of Cure Visit (Full Analysis Set) [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ]
  • Percentage of Clinical Cure (Success)at Test of Cure Visit(Clinically Eligible Set) [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ]
  • Percentage of Bacteriologic Response at Test of Cure Visit [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ]
  • Time Taken for First Quartile (25%) of Subjects to Have AECB Recurrence [ Time Frame: Number of Days ]
  • Change From Baseline in Clinical COPD Questionnaire(CCQ)Total Score [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ]
  • Change From Baseline in Clinical COPD Questionnaire(CCQ)Symptoms Score [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ]
  • Change From Baseline in Clinical COPD Questionnaire(CCQ)Functional State Score [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ]
  • Change From Baseline in Clinical COPD Questionnaire(CCQ)Mental State Score [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ]


Original Secondary Outcome: Bacteriologic response at Test of cure visit Time to first recurrence of AECB Health status Safety and tolerability

Information By: Pfizer

Dates:
Date Received: November 14, 2005
Date Started: February 2006
Date Completion:
Last Updated: November 3, 2009
Last Verified: November 2009