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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 2
• Active Comparator: 1

Primary Measures

• Clinical Response at Test of Cure Visit
  • Time Frame: Day12-19
    Safety Issue?: No

Secondary Measures

• Bacteriologic response at Test of cure visit
  • Time Frame: Day12-19
    Safety Issue?: No
• Time to first recurrence of AECB
  • Time Frame: recurrence date
    Safety Issue?: No
• Health status documented in the clinical COPD Questionnaire(CCQ)
  • Time Frame: day1-7, TOC, first follow-up visit
    Safety Issue?: No
• Safety and tolerability
  • Time Frame: during the whole study
    Safety Issue?: Yes

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
• 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 Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on October 10, 2008

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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