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

May 12, 2011 updated by: Pfizer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

551

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • PR
      • Curitiba, PR, Brazil, 80060-900
        • Pfizer Investigational Site
    • RS
      • Porto Alegre, RS, Brazil, 90610-000
        • Pfizer Investigational Site
      • Porto Alegre, RS, Brazil, 90035-003
        • Pfizer Investigational Site
      • Porto Alegre, RS, Brazil, 90035-002
        • Pfizer Investigational Site
      • Porto Alegre, RS, Brazil, 90035-074
        • Pfizer Investigational Site
    • SP
      • Santo André, SP, Brazil, 09060-650
        • Pfizer Investigational Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5A 4L8
        • Pfizer Investigational Site
      • Edmonton, Alberta, Canada, T5N 2N8
        • Pfizer Investigational Site
    • Nova Scotia
      • Sydney, Nova Scotia, Canada, B1S 1A9
        • Pfizer Investigational Site
    • Ontario
      • Hawkesbury, Ontario, Canada, K6A 1A1
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M9W 4L6
        • Pfizer Investigational Site
    • Quebec
      • Ste-Foy, Quebec, Canada, G1V 4G5
        • Pfizer Investigational Site
    • Saskatchewan
      • North Battleford, Saskatchewan, Canada, S9A 0V6
        • Pfizer Investigational Site
      • Saskatoon, Saskatchewan, Canada, S7K 3H3
        • Pfizer Investigational Site
  • Costa Rica
      • San Jose, Costa Rica
        • Pfizer Investigational Site
    • San Jose
      • Desamparados, San Jose, Costa Rica
        • Pfizer Investigational Site
      • Guadalupe, San Jose, Costa Rica
        • Pfizer Investigational Site
      • La Uruca, San Jose, Costa Rica
        • Pfizer Investigational Site
      • Pavas, San Jose, Costa Rica
        • Pfizer Investigational Site
      • Pinares de Curridabat, San Jose, Costa Rica
        • Pfizer Investigational Site
  • Germany
      • Berlin, Germany, 10965
        • Pfizer Investigational Site
      • Rathenow, Germany, 14712
        • Pfizer Investigational Site
  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560 034
        • Pfizer Investigational Site
    • Kerala
      • Elamakkara, Cochin, Kerala, India, 682 026
        • Pfizer Investigational Site
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452 001
        • Pfizer Investigational Site
    • Maharashtra
      • Pune, Maharashtra, India, 411 053
        • Pfizer Investigational Site
    • Punjab
      • Ludhiana, Punjab, India, 141 001
        • Pfizer Investigational Site
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, India, 641022
        • Pfizer Investigational Site
  • Lithuania
      • Alytus, Lithuania, LT-4580
        • Pfizer Investigational Site
      • Klaipeda, Lithuania, LT-5800
        • Pfizer Investigational Site
      • Vilnius, Lithuania, LT-2010
        • Pfizer Investigational Site
  • Mexico
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Pfizer Investigational Site
  • Netherlands
      • Eindhoven, Netherlands, 5623 EJ
        • Pfizer Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 105077
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 105229
        • Pfizer Investigational Site
      • Moscow, Russian Federation
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 107066
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 119048
        • Pfizer Investigational Site
      • Smolensk, Russian Federation, 214019
        • Pfizer Investigational Site
  • Spain
      • Madrid, Spain, 28006
        • Pfizer Investigational Site
      • Madrid, Spain, 28007
        • Pfizer Investigational Site
      • Málaga, Spain, 29010
        • Pfizer Investigational Site
  • United Kingdom
      • Glasgow, United Kingdom, G45 9AW
        • Pfizer Investigational Site
    • Warwickshire
      • Atherstone, Warwickshire, United Kingdom, CV9 1EU
        • Pfizer Investigational Site
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS12 1JE
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35215
        • Pfizer Investigational Site
      • Columbiana, Alabama, United States, 35051
        • Pfizer Investigational Site
      • Tallassee, Alabama, United States, 36078
        • Pfizer Investigational Site
    • Arizona
      • Mesa, Arizona, United States, 85201
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85014
        • Pfizer Investigational Site
      • Tempe, Arizona, United States, 85282
        • Pfizer Investigational Site
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • Pfizer Investigational Site
      • Merritt Island, Florida, United States, 32953
        • Pfizer Investigational Site
    • Georgia
      • Austell, Georgia, United States, 30106
        • Pfizer Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47712
        • Pfizer Investigational Site
    • Kentucky
      • Madisonville, Kentucky, United States, 42431
        • Pfizer Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Pfizer Investigational Site
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
        • Pfizer Investigational Site
      • Royal Oak, Michigan, United States, 48073
        • Pfizer Investigational Site
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
        • Pfizer Investigational Site
    • Nebraska
      • Elkhorn, Nebraska, United States, 68022
        • Pfizer Investigational Site
      • Omaha, Nebraska, United States, 68105
        • Pfizer Investigational Site
      • Omaha, Nebraska, United States, 68144
        • Pfizer Investigational Site
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Pfizer Investigational Site
      • Columbus, Ohio, United States, 43215
        • Pfizer Investigational Site
      • Columbus, Ohio, United States, 43222
        • Pfizer Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18102
        • Pfizer Investigational Site
      • Harrisburg, Pennsylvania, United States, 17011
        • Pfizer Investigational Site
      • Harrisburg, Pennsylvania, United States, 17110
        • Pfizer Investigational Site
      • Morrisville, Pennsylvania, United States, 19067
        • Pfizer Investigational Site
      • Willow Grove, Pennsylvania, United States, 19090
        • Pfizer Investigational Site
    • Tennessee
      • Milan, Tennessee, United States, 38358
        • Pfizer Investigational Site
    • Texas
      • San Antonio, Texas, United States, 78224
        • Pfizer Investigational Site
  • Venezuela
      • Caracas, Venezuela
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
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
Experimental: 2
Other: placebo
placebo
Drug: levofloxacin
500 mg (two 250 mg capsules) by mouth once daily for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
sponsor assessment of clinical response in the Clinical Per Protocol population
Time Frame: Test of Cure (TOC) visit (Day 14-21)
Test of Cure (TOC) visit (Day 14-21)

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse events
Time Frame: Continuous
Continuous
bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population
Time Frame: TOC visit
TOC visit
investigator assessment of clinical response in the Clinical Per Protocol population
Time Frame: TOC visit
TOC visit
sponsor assessment of clinical response in the Clinical Per Protocol population
Time Frame: Long-Term Follow-Up (LTFU) visit (Day 28-35)
Long-Term Follow-Up (LTFU) visit (Day 28-35)
Summary of baseline susceptibilities
Time Frame: Study Endpoint
Study Endpoint
clinical laboratory tests
Time Frame: Baseline and EOT visit
Baseline and EOT visit
sponsor assessment of clinical response in the Clinical Per Protocol population
Time Frame: End of Treatment (EOT) visit (Day 8-11)
End of Treatment (EOT) visit (Day 8-11)
sponsor assessment of clinical response in the remaining study populations
Time Frame: TOC visit
TOC visit
sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population
Time Frame: EOT visit and TOC visit
EOT visit and TOC visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Completion (Actual)

March 1, 2004

Study Registration Dates

First Submitted

March 19, 2008

First Submitted That Met QC Criteria

March 19, 2008

First Posted (Estimate)

March 26, 2008

Study Record Updates

Last Update Posted (Estimate)

May 16, 2011

Last Update Submitted That Met QC Criteria

May 12, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0661102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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