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

NCT00644449 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 551

Last updated 2011-05-16

No results posted yet for this study

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

Conditions

  • Bronchitis, Chronic

Interventions

OTHER

placebo

placebo

DRUG

azithromycin SR (Zithromax; compound: CP-62,993)

azithromycin 2.0 g by mouth in the form of a slurry for 1 dose

OTHER

placebo

placebo

DRUG

levofloxacin

500 mg (two 250 mg capsules) by mouth once daily for 7 days

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Completion
2004-03-31

Countries

  • United States
  • Brazil
  • Canada
  • Costa Rica
  • Germany
  • India
  • Lithuania
  • Mexico
  • Netherlands
  • Russia
  • Spain
  • United Kingdom
  • Venezuela

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00644449 on ClinicalTrials.gov