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

Study Overview
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Brief Summary
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This trial is a research drug study to compare the effects of two antibiotics for the treatment of acute exacerbation of chronic bronchitis

Official Title
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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).

Conditions
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Chronic Bronchitis

Intervention / Treatment
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* Other: Moxifloxacin Placebo
* Drug: Moxifloxacin
* Other: Azithromycin SR Placebo
* Drug: Azithromycin SR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Other: Azithromycin SR Placebo<br>* single dose, oral.<br>Drug: Azithromycin SR<br>* single dose 2.0 g oral<br>|
| Active Comparator: 2<br> | Other: Moxifloxacin Placebo<br>* 1 capsule once daily for 5 days<br>Drug: Moxifloxacin<br>* 1 X 400mg capsule once daily for 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Test of Cure (TOC) Visit (Day 12-19) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | Test of Cure (TOC) Visit (Day 12-19) | 
| Time Taken for First Quartile (25%) of Subjects to Have AECB Recurrence | 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. | Number of Days | 
| Change From Baseline in Clinical COPD Questionnaire(CCQ)Total 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 | Test of Cure (TOC) Visit (Day 12-19) | 
| Change From Baseline in Clinical COPD Questionnaire(CCQ)Symptoms 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 | Test of Cure (TOC) Visit (Day 12-19) | 
| Change From Baseline in Clinical COPD Questionnaire(CCQ)Functional State Score | 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 | Test of Cure (TOC) Visit (Day 12-19) | 
| Change From Baseline in Clinical COPD Questionnaire(CCQ)Mental State 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 | Test of Cure (TOC) Visit (Day 12-19) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Azithromycin SR; Moxifloxacin; Acute exacerbation of chronic bronchitis (AECB)