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

Phase 3

Completed

Conditions: Chronic Bronchitis

Interventions: Other: Azithromycin SR Placebo
Other: Moxifloxacin Placebo
Drug: Azithromycin SR
Drug: Moxifloxacin

Registration Number: NCT00254566

Lead Sponsor: Pfizer

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 Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 398

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Azithromycin SR	-
1	Azithromycin SR Placebo	-
2	Moxifloxacin Placebo	-
2	Moxifloxacin	-

Primary Outcome Measures

Name	Time	Method
Percentage of Clinical Cure (Success) at Test of Cure Visit(Clinical Per Protocol Population)	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 Outcome Measures

Name	Time	Method
Percentage of Clinical Cure (Success) at Test of Cure Visit (Full Analysis Set)	Test of Cure (TOC) Visit (Day 12-19)	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
Percentage of Bacteriologic Response at Test of Cure Visit	Test of Cure (TOC) Visit (Day 12-19)	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
Change From Baseline in Clinical COPD Questionnaire(CCQ)Symptoms Score	Test of Cure (TOC) Visit (Day 12-19)	1 of 3 domains that combined into the CCQ Total score. Items 1,2,5,and 6 address symptoms. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely symptomatic; change=mean score at observation minus mean score at baseline
Change From Baseline in Clinical COPD Questionnaire(CCQ)Functional State Score	Test of Cure (TOC) Visit (Day 12-19)	1 of 3 domains that combined into the CCQ Total score. Items 7,8,9, and 10 address functional state. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely; change=mean score at observation minus mean score at baseline
Percentage of Clinical Cure (Success)at Test of Cure Visit(Clinically Eligible Set)	Test of Cure (TOC) Visit (Day 12-19)	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 Taken for First Quartile (25%) of Subjects to Have AECB Recurrence	Number of Days	Subject is considered to have AECB recurrence if they had a clinical response of cure at the TOC visit and then met the definition of AECB during the follow-up period.
Change From Baseline in Clinical COPD Questionnaire(CCQ)Total Score	Test of Cure (TOC) Visit (Day 12-19)	CCQ was developed to measure health status of Chronic obstructive pulmonary disease (COPD) subjects. 10 items divided into 3 domains: symtoms, functional state, and mental state. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely symptomatic/totally limited; change=mean score at observation minus mean score at baseline
Change From Baseline in Clinical COPD Questionnaire(CCQ)Mental State Score	Test of Cure (TOC) Visit (Day 12-19)	1 of 3 domains that combined into the CCQ Total score. Items 3 and 4 address mental state. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely; change=mean score at observation minus mean score at baseline