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

Completed · Phase 3 · Has a placebo group

Conditions studied: Bronchitis, Chronic

In brief

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

Key facts

Study ID

NCT00644449

Run by

Pfizer

People needed

551

Starts

2003-01-01

Expected to finish

2004-03-01

Last updated by the study team

2011-05-16

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Pfizer Investigational Site — Birmingham, Alabama, United States
• Pfizer Investigational Site — Columbiana, Alabama, United States
• Pfizer Investigational Site — Tallassee, Alabama, United States
• Pfizer Investigational Site — Mesa, Arizona, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Tempe, Arizona, United States
• Pfizer Investigational Site — Daytona Beach, Florida, United States
• Pfizer Investigational Site — Merritt Island, Florida, United States
• Pfizer Investigational Site — Austell, Georgia, United States
• Pfizer Investigational Site — Evansville, Indiana, United States
• Pfizer Investigational Site — Madisonville, Kentucky, United States
• Pfizer Investigational Site — New Orleans, Louisiana, United States
• Pfizer Investigational Site — Kalamazoo, Michigan, United States
• Pfizer Investigational Site — Royal Oak, Michigan, United States
• Pfizer Investigational Site — Olive Branch, Mississippi, United States
• Pfizer Investigational Site — Elkhorn, Nebraska, United States
• Pfizer Investigational Site — Omaha, Nebraska, United States
• Pfizer Investigational Site — Omaha, Nebraska, United States
• Pfizer Investigational Site — Columbus, Ohio, United States
• Pfizer Investigational Site — Columbus, Ohio, United States
• Pfizer Investigational Site — Columbus, Ohio, United States
• Pfizer Investigational Site — Allentown, Pennsylvania, United States
• Pfizer Investigational Site — Harrisburg, Pennsylvania, United States
• Pfizer Investigational Site — Harrisburg, Pennsylvania, United States
• Pfizer Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.