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

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 Of Acute Exacerbation Of Chronic Bronchitis (AECB).”

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

Intervention(s) in this Clinical Trial

• Other: Moxifloxacin Placebo
  • 1 capsule once daily for 5 days
• Drug: Moxifloxacin
  • 1 X 400mg capsule once daily for 5 days
• Other: Azithromycin SR Placebo
  • single dose, oral.
• Drug: Azithromycin SR
  • single dose 2.0 g oral

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Percentage of Clinical Cure (Success) at Test of Cure Visit(Clinical Per Protocol Population)
  • Time Frame: Test of Cure (TOC) Visit (Day 12-19)
    Safety Issue?: No

Secondary Measures

• Percentage of Clinical Cure (Success) at Test of Cure Visit (Full Analysis Set)
  • Time Frame: Test of Cure (TOC) Visit (Day 12-19)
    Safety Issue?: No
• Percentage of Clinical Cure (Success)at Test of Cure Visit(Clinically Eligible Set)
  • Time Frame: Test of Cure (TOC) Visit (Day 12-19)
    Safety Issue?: No
• Percentage of Bacteriologic Response at Test of Cure Visit
  • Time Frame: Test of Cure (TOC) Visit (Day 12-19)
    Safety Issue?: No
• Time Taken for First Quartile (25%) of Subjects to Have AECB Recurrence
  • Time Frame: Number of Days
    Safety Issue?: No
• Change From Baseline in Clinical COPD Questionnaire(CCQ)Total Score
  • Time Frame: Test of Cure (TOC) Visit (Day 12-19)
    Safety Issue?: No
• Change From Baseline in Clinical COPD Questionnaire(CCQ)Symptoms Score
  • Time Frame: Test of Cure (TOC) Visit (Day 12-19)
    Safety Issue?: No
• Change From Baseline in Clinical COPD Questionnaire(CCQ)Functional State Score
  • Time Frame: Test of Cure (TOC) Visit (Day 12-19)
    Safety Issue?: No
• Change From Baseline in Clinical COPD Questionnaire(CCQ)Mental State Score
  • Time Frame: Test of Cure (TOC) Visit (Day 12-19)
    Safety Issue?: No

Inclusion Criteria:

• Diagnosis of chronic bronchitis (chronic cough and sputum production on most days for three consecutive months for more than two consecutive years) and clinical evidence of AECB as demonstrated by both the following symptoms:
• Production of purulent sputum as defined by Gram stained sputum specimen
• Presence of all of the following:
• Increased sputum production
• Increased dyspnea
• Increased cough
• At least two exacerbations of AECB in the past 12 months
• Documented FEV1 less than 80% of predicted

Exclusion Criteria:

• A chest radiograph consistent with pneumonia
• Treatment with any systemic antibiotic within the twenty-one days prior to study entry or those with a chance of receiving other systemic antibiotics during study participation

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00254566

Study ID Number: A0661147

ClinicalTrials.gov Identifier: NCT00254566

Health Authority: Singapore: Health Sciences Authority

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