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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

Primary Purpose

Bronchitis, Chronic

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
placebo
azithromycin SR (Zithromax; compound: CP-62,993)
placebo
levofloxacin
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchitis, Chronic

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site
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  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

sponsor assessment of clinical response in the Clinical Per Protocol population

Secondary Outcome Measures

investigator assessment of clinical response in the Clinical Per Protocol population
bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population
sponsor assessment of clinical response in the Clinical Per Protocol population
Summary of baseline susceptibilities
adverse events
clinical laboratory tests
sponsor assessment of clinical response in the Clinical Per Protocol population
sponsor assessment of clinical response in the remaining study populations
sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population

Full Information

First Posted
March 19, 2008
Last Updated
May 12, 2011
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00644449
Brief Title
A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Acute Symptoms of Chronic Bronchitis
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchitis, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
551 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo
Intervention Type
Drug
Intervention Name(s)
azithromycin SR (Zithromax; compound: CP-62,993)
Intervention Description
azithromycin 2.0 g by mouth in the form of a slurry for 1 dose
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo
Intervention Type
Drug
Intervention Name(s)
levofloxacin
Intervention Description
500 mg (two 250 mg capsules) by mouth once daily for 7 days
Primary Outcome Measure Information:
Title
sponsor assessment of clinical response in the Clinical Per Protocol population
Time Frame
Test of Cure (TOC) visit (Day 14-21)
Secondary Outcome Measure Information:
Title
investigator assessment of clinical response in the Clinical Per Protocol population
Time Frame
TOC visit
Title
bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population
Time Frame
TOC visit
Title
sponsor assessment of clinical response in the Clinical Per Protocol population
Time Frame
Long-Term Follow-Up (LTFU) visit (Day 28-35)
Title
Summary of baseline susceptibilities
Time Frame
Study Endpoint
Title
adverse events
Time Frame
Continuous
Title
clinical laboratory tests
Time Frame
Baseline and EOT visit
Title
sponsor assessment of clinical response in the Clinical Per Protocol population
Time Frame
End of Treatment (EOT) visit (Day 8-11)
Title
sponsor assessment of clinical response in the remaining study populations
Time Frame
TOC visit
Title
sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population
Time Frame
EOT visit and TOC visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35215
Country
United States
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Pfizer Investigational Site
City
Columbiana
State/Province
Alabama
ZIP/Postal Code
35051
Country
United States
Facility Name
Pfizer Investigational Site
City
Tallassee
State/Province
Alabama
ZIP/Postal Code
36078
Country
United States
Facility Name
Pfizer Investigational Site
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85201
Country
United States
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Pfizer Investigational Site
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Pfizer Investigational Site
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
Pfizer Investigational Site
City
Merritt Island
State/Province
Florida
ZIP/Postal Code
32953
Country
United States
Facility Name
Pfizer Investigational Site
City
Austell
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
Facility Name
Pfizer Investigational Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47712
Country
United States
Facility Name
Pfizer Investigational Site
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
Facility Name
Pfizer Investigational Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Pfizer Investigational Site
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Pfizer Investigational Site
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Pfizer Investigational Site
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Facility Name
Pfizer Investigational Site
City
Elkhorn
State/Province
Nebraska
ZIP/Postal Code
68022
Country
United States
Facility Name
Pfizer Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
Facility Name
Pfizer Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Pfizer Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Pfizer Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Pfizer Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43222
Country
United States
Facility Name
Pfizer Investigational Site
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18102
Country
United States
Facility Name
Pfizer Investigational Site
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Pfizer Investigational Site
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17110
Country
United States
Facility Name
Pfizer Investigational Site
City
Morrisville
State/Province
Pennsylvania
ZIP/Postal Code
19067
Country
United States
Facility Name
Pfizer Investigational Site
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
Pfizer Investigational Site
City
Milan
State/Province
Tennessee
ZIP/Postal Code
38358
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78224
Country
United States
Facility Name
Pfizer Investigational Site
City
Curitiba
State/Province
PR
ZIP/Postal Code
80060-900
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-002
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-003
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-074
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Santo André
State/Province
SP
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5A 4L8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5N 2N8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sydney
State/Province
Nova Scotia
ZIP/Postal Code
B1S 1A9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Hawkesbury
State/Province
Ontario
ZIP/Postal Code
K6A 1A1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Pfizer Investigational Site
City
North Battleford
State/Province
Saskatchewan
ZIP/Postal Code
S9A 0V6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 3H3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Desamparados
State/Province
San Jose
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
Guadalupe
State/Province
San Jose
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
La Uruca
State/Province
San Jose
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
Pavas
State/Province
San Jose
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
Pinares de Curridabat
State/Province
San Jose
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
San Jose
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
10965
Country
Germany
Facility Name
Pfizer Investigational Site
City
Rathenow
ZIP/Postal Code
14712
Country
Germany
Facility Name
Pfizer Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 034
Country
India
Facility Name
Pfizer Investigational Site
City
Elamakkara, Cochin
State/Province
Kerala
ZIP/Postal Code
682 026
Country
India
Facility Name
Pfizer Investigational Site
City
Indore
State/Province
Madhya Pradesh
ZIP/Postal Code
452 001
Country
India
Facility Name
Pfizer Investigational Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 053
Country
India
Facility Name
Pfizer Investigational Site
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141 001
Country
India
Facility Name
Pfizer Investigational Site
City
Coimbatore
State/Province
Tamil Nadu
ZIP/Postal Code
641022
Country
India
Facility Name
Pfizer Investigational Site
City
Alytus
ZIP/Postal Code
LT-4580
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Klaipeda
ZIP/Postal Code
LT-5800
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Vilnius
ZIP/Postal Code
LT-2010
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
105077
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
107066
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
119048
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Pfizer Investigational Site
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Pfizer Investigational Site
City
Atherstone
State/Province
Warwickshire
ZIP/Postal Code
CV9 1EU
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS12 1JE
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Glasgow
ZIP/Postal Code
G45 9AW
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Caracas
Country
Venezuela

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661102&StudyName=A%20Multicenter%2C%20Randomized%2C%20Double-Blind%2C%20Double-Dummy%20Trial%20of%20Azithromycin%20SR%20Compared%20with%20Levofloxacin%20for%20the%20Treatment%20of%20Acute%20S
Description
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Learn more about this trial

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

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