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).

Pfizer1 site in 1 country398 target enrollmentFebruary 2006

ConditionsChronic Bronchitis

InterventionsAzithromycin SR Placebo Azithromycin SR Moxifloxacin Placebo Moxifloxacin

DrugsMoxifloxacin Azithromycin SR

Overview

Phase: Phase 3
Intervention: Azithromycin SR Placebo
Conditions: Chronic Bronchitis
Sponsor: Pfizer
Enrollment: 398
Locations: 1
Primary Endpoint: Percentage of Clinical Cure (Success) at Test of Cure Visit(Clinical Per Protocol Population)
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

February 2006

End Date

August 2008

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Eligibility Criteria

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

Arms & Interventions

1

Intervention: Azithromycin SR Placebo

1

Intervention: Azithromycin SR

2

Intervention: Moxifloxacin Placebo

2

Intervention: Moxifloxacin

Outcomes

Primary Outcomes

Percentage of Clinical Cure (Success) at Test of Cure Visit(Clinical Per Protocol Population)

Time Frame: Test of Cure (TOC) Visit (Day 12-19)

Cure=Signs\&symptoms(S\&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S\&S of acute infection persisted/worsened,new clinical S\&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub

Secondary Outcomes

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