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

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)

Population: Clinical Per Protocol-all randomized subjects who were clinically eligible; received at least 80% of study med; no concomitant systemic antibiotics with activity against Acute Exacerbation of Chronic Bronchitis (AECB) pathogens, assessment made in appropriate visit window.

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

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

Population: Analysis on Full Analysis Set, LOCF-missing values at the TOC visit will be imputed by carrying forward the last post baseline observation. Domain score is calculated by deriving the simple average of the relevant items, at least 75% of items must be non-missing to derive the domain score

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

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

Population: Analysis on Full Analysis Set, LOCF-missing values at TOC will be imputed by carrying forward the last post-baseline observation; Domain score is calculated by deriving the simple average of the relevant items, both mental state items must be non-missing to derive a mental state score

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

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

Population: Analysis on Full Analysis Set, LOCF - missing values at the TOC visit will be imputed by carrying forward the last post baseline observation. Domain score is calculated by deriving the simple average of the relevant items, at least 75% of items must be non-missing to derive the domain score

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

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

Population: Analysis on Full Analysis Set, Last Observation Carried Forward (LOCF)-missing values at TOC visit will be imputed by carrying forward the last post-baseline observation; total score calculated by deriving the simple average of relevant items, total score is set to missing if 1 or more domain scales cannot be derived.

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

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

Population: Bacteriologic per protocol set is compromised of subjects from the Clinical Per Protocol set with a baseline bacterial pathogen. The number of participants is the number of unique pathogens identified at baseline.

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)

Population: Clinically eligible compromised of subjects from FAS with diagnosis of chronic bronchitis, clinical evidence of AECB based on S\&S, \& a neg chest radiograph for pneumonia based on radiologist opinion

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)

Population: Full Analysis Set (FAS) is all randomized subjects who received at least 1 dose of study medication.

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.

Time frame: Number of Days

Population: Time to AECB recurrence will be analyzed for the FAS using survival analysis methods to account for censored observations. Subjects are censored at the date last known to have not experienced a recurrence. Median time to recurrence will be estimated using the Kaplan-Meier method.