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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

NCT ID: NCT00644449

Last Updated: 2011-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

551 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2004-03-31

Brief Summary

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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

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Detailed Description

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Conditions

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Bronchitis, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

placebo

Intervention Type OTHER

placebo

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

Intervention Type DRUG

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

2

Group Type EXPERIMENTAL

placebo

Intervention Type OTHER

placebo

levofloxacin

Intervention Type DRUG

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

Interventions

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placebo

placebo

Intervention Type OTHER

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

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

Intervention Type DRUG

placebo

placebo

Intervention Type OTHER

levofloxacin

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Birmingham, Alabama, United States

Site Status

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Birmingham, Alabama, United States

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Columbiana, Alabama, United States

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Tallassee, Alabama, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Tempe, Arizona, United States

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Daytona Beach, Florida, United States

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Merritt Island, Florida, United States

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Austell, Georgia, United States

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Evansville, Indiana, United States

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Madisonville, Kentucky, United States

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New Orleans, Louisiana, United States

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Kalamazoo, Michigan, United States

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Royal Oak, Michigan, United States

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Olive Branch, Mississippi, United States

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Elkhorn, Nebraska, United States

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Omaha, Nebraska, United States

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Omaha, Nebraska, United States

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Columbus, Ohio, United States

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Columbus, Ohio, United States

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Columbus, Ohio, United States

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Allentown, Pennsylvania, United States

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Harrisburg, Pennsylvania, United States

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Harrisburg, Pennsylvania, United States

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Morrisville, Pennsylvania, United States

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Willow Grove, Pennsylvania, United States

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Milan, Tennessee, United States

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San Antonio, Texas, United States

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Curitiba, Paraná, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Santo André, São Paulo, Brazil

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Edmonton, Alberta, Canada

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Edmonton, Alberta, Canada

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Sydney, Nova Scotia, Canada

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Hawkesbury, Ontario, Canada

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Toronto, Ontario, Canada

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Ste-Foy, Quebec, Canada

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North Battleford, Saskatchewan, Canada

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Saskatoon, Saskatchewan, Canada

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Desamparados, Provincia de San José, Costa Rica

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Guadalupe, Provincia de San José, Costa Rica

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Pavas, Provincia de San José, Costa Rica

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Pinares de Curridabat, Provincia de San José, Costa Rica

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San José, Provincia de San José, Costa Rica

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Uruca, Provincia de San José, Costa Rica

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Berlin, , Germany

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Rathenow, , Germany

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Bangalore, Karnataka, India

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Elamakkara, Cochin, Kerala, India

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Indore, Madhya Pradesh, India

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Pune, Maharashtra, India

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Ludhiana, Punjab, India

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Coimbatore, Tamil Nadu, India

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Alytus, , Lithuania

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Klaipėda, , Lithuania

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Vilnius, , Lithuania

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Monterrey, Nuevo León, Mexico

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Eindhoven, , Netherlands

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Smolensk, , Russia

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Madrid, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Atherstone, Warwickshire, United Kingdom

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Leeds, West Yorkshire, United Kingdom

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Glasgow, , United Kingdom

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Caracas, , Venezuela

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Countries

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

Related Links

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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

To obtain contact information for a study center near you, click here.

Other Identifiers

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A0661102

Identifier Type: -

Identifier Source: org_study_id

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