A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Acute Symptoms of Chronic Bronchitis

Study Overview
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Brief Summary
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This study was performed to confirm that a single 2.0-g dose of azithromycin SR is at least as effective as 7 days of levofloxacin 500 mg/day in adults with acute exacerbation of chronic bronchitis Secondary objectives: To assess safety and the bacteriologic efficacy of both treatment regimens

Official Title
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A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Levofloxacin for the Treatment of Acute Exacerbation of Chronic Bronchitis (AECB)

Conditions
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Bronchitis, Chronic

Intervention / Treatment
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* Other: placebo
* Drug: azithromycin SR (Zithromax; compound: CP-62,993)
* Other: placebo
* Drug: levofloxacin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with a history of chronic bronchitis (i.e., chronic cough and sputum production on most days for 3 consecutive months for more than 2 years) and current evidence of an acute bacterial exacerbation of their disease, as demonstrated by production of purulent sputum and the presence of at lest 2 of the following signs and symptoms, were included: increased sputum production, increased dypsnea, increased cough, or increased sputum purulence. Exclusion Criteria: Key exclusion criteria were treatment with any systemic antibiotic within the previous 7 days, or the likelihood of receiving other systemic antibiotics during participation in the study; a chest radiograph consistent with pneumonia; and previously diagnosed conditions which tend to mimic or complicate the course and evaluation of the infectious process (e.g., bronchiectasis, lung abscess or empyema, active TB, pulmonary malignancy, cystic fibrosis).

Ages Eligible for Study
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Minimum Age: 35 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: placebo<br>* placebo<br>Drug: azithromycin SR (Zithromax; compound: CP-62,993)<br>* azithromycin 2.0 g by mouth in the form of a slurry for 1 dose<br>|
| Experimental: 2<br> | Other: placebo<br>* placebo<br>Drug: levofloxacin<br>* 500 mg (two 250 mg capsules) by mouth once daily for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sponsor assessment of clinical response in the Clinical Per Protocol population |  | Test of Cure (TOC) visit (Day 14-21) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| investigator assessment of clinical response in the Clinical Per Protocol population |  | TOC visit | 
| bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population |  | TOC visit | 
| sponsor assessment of clinical response in the Clinical Per Protocol population |  | Long-Term Follow-Up (LTFU) visit (Day 28-35) | 
| Summary of baseline susceptibilities |  | Study Endpoint | 
| adverse events |  | Continuous | 
| clinical laboratory tests |  | Baseline and EOT visit | 
| sponsor assessment of clinical response in the Clinical Per Protocol population |  | End of Treatment (EOT) visit (Day 8-11) | 
| sponsor assessment of clinical response in the remaining study populations |  | TOC visit | 
| sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population |  | EOT visit and TOC visit |