Status:
COMPLETED
A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Acute Symptoms of Chronic Bronchitis
Lead Sponsor:
Pfizer
Conditions:
Bronchitis, Chronic
Eligibility:
All Genders
35+ years
Phase:
PHASE3
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 Se...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2004
Estimated Enrollment :
551 Patients enrolled
Trial Details
Trial ID
NCT00644449
Start Date
January 1 2003
End Date
March 1 2004
Last Update
May 16 2011
Active Locations (75)
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1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35215
2
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233
3
Pfizer Investigational Site
Columbiana, Alabama, United States, 35051
4
Pfizer Investigational Site
Tallassee, Alabama, United States, 36078