Skip to main content
OpenTrials
Completed

NCT Number: NCT00644449

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Curitiba, Paraná, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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).

Treatment and study plan

Placebo

Other

placebo

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

Drug

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

Levofloxacin

Drug

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

Primary outcomes

  1. sponsor assessment of clinical response in the Clinical Per Protocol population

    Time frame: Test of Cure (TOC) visit (Day 14-21)

Secondary outcomes

  1. investigator assessment of clinical response in the Clinical Per Protocol population

    Time frame: TOC visit

  2. bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population

    Time frame: TOC visit

  3. sponsor assessment of clinical response in the Clinical Per Protocol population

    Time frame: Long-Term Follow-Up (LTFU) visit (Day 28-35)

  4. Summary of baseline susceptibilities

    Time frame: Study Endpoint

  5. adverse events

    Time frame: Continuous

  6. clinical laboratory tests

    Time frame: Baseline and EOT visit

  7. sponsor assessment of clinical response in the Clinical Per Protocol population

    Time frame: End of Treatment (EOT) visit (Day 8-11)

  8. sponsor assessment of clinical response in the remaining study populations

    Time frame: TOC visit

  9. sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population

    Time frame: EOT visit and TOC visit

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Levofloxacin for the Treatment of Acute Exacerbation of Chronic Bronchitis (AECB)

Important dates

Study start
2003
Study completion
2004
First posted
Mar 26, 2008
Registry last updated
May 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.