Trials / Completed
CompletedNCT00644449
A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Acute Symptoms of Chronic Bronchitis
A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Levofloxacin for the Treatment of Acute Exacerbation of Chronic Bronchitis (AECB)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 551 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 35 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2003-01-01
- Completion
- 2004-03-01
- First posted
- 2008-03-26
- Last updated
- 2011-05-16
Locations
75 sites across 13 countries: United States, Brazil, Canada, Costa Rica, Germany, India, Lithuania, Mexico, Netherlands, Russia, Spain, United Kingdom, Venezuela
Source: ClinicalTrials.gov record NCT00644449. Inclusion in this directory is not an endorsement.