Bronchitis, Chronic
Conditions
Brief summary
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
Interventions
OTHERplacebo
placebo
azithromycin 2.0 g by mouth in the form of a slurry for 1 dose
DRUGlevofloxacin
500 mg (two 250 mg capsules) by mouth once daily for 7 days
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sponsor assessment of clinical response in the Clinical Per Protocol population | Test of Cure (TOC) visit (Day 14-21) |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| investigator assessment of clinical response in the Clinical Per Protocol population | TOC visit |
| clinical laboratory tests | Baseline and EOT visit |
| 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 |
| adverse events | Continuous |
Countries
Brazil, Canada, Costa Rica, Germany, India, Lithuania, Mexico, Netherlands, Russia, Spain, United Kingdom, United States, Venezuela
Outcome results
None listed