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

Pfizer398 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

398

Conditions

Chronic Bronchitis

Interventions

Moxifloxacin PlaceboOTHER

1 capsule once daily for 5 days

MoxifloxacinDRUG

1 X 400mg capsule once daily for 5 days

Azithromycin SR PlaceboOTHER

single dose, oral.

Azithromycin SR

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (34)

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

Percentage of Clinical Cure (Success) at Test of Cure Visit (Full Analysis Set)

Clinical response (Cure vs Failure) at the TOC visit for the Full Analysis Set (FAS), 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

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

Percentage of Clinical Cure (Success)at Test of Cure Visit(Clinically Eligible Set)

Clinical Response at TOC Visit for clinically Eligible Subjects, 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

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

Percentage of Bacteriologic Response at Test of Cure Visit

Bacteriogical response assessed on per pathogen basis for Bacteriologic Per Protcol (BPP) set at TOC Visit. If no repeat culture, response is presumed from sponsor assessment of clinical response. Eradication =# of pathogens eradicated at TOC/N; Persistence =# of pathogens persistent at TOC/N; N=# of unique pathogens identified at baseline

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Guangzhou, Guangdong, China

Pfizer Investigational Site

Shijiazhuang, Hebei, China

Pfizer Investigational Site

Nanjing, Jiangsu, China

Pfizer Investigational Site

Shenyang, Liaoning, China

Pfizer Investigational Site

Xi’an, Shanxi, China

Pfizer Investigational Site

Xi’an, Shanxi, China

Pfizer Investigational Site

Hangzhou, Zhejiang, China

Pfizer Investigational Site

Beijing, China

Pfizer Investigational Site

Beijing, China

Pfizer Investigational Site

Chongqing, China

...and 24 more locations