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A Multicentre, Randomised, Open-Label Study To Compare The Efficacy And Safety Of Azithromycin For 5 Days With Those Of Amoxicillin-Clavulanic Acid In Patients With Chronic Bronchitis

NCT ID: NCT00649831

Last Updated: 2008-10-21

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

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2003-06-30

Brief Summary

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This study compared the clinical efficacy and safety of azithromycin with that of amoxicillin-clavulanic acid, in patients between the ages of 35 and 75 years, presenting with an exacerbation of chronic bronchitis.

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

NONE

Study Groups

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Group 2

Group Type ACTIVE_COMPARATOR

Amoxicillin/clavulinic acid

Intervention Type DRUG

amoxicillin/clavulinic acid 500 mg/62.5 mg tablet; take 2 tablets by mouth twice daily (BID) for 10 days

Group 1

Group Type ACTIVE_COMPARATOR

Azithromycin

Intervention Type DRUG

Azithromycin 250 mg tablet; take 2 tablets by mouth on the first day, then 1 tablet by mouth from Days 2 to 5

Interventions

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Amoxicillin/clavulinic acid

amoxicillin/clavulinic acid 500 mg/62.5 mg tablet; take 2 tablets by mouth twice daily (BID) for 10 days

Intervention Type DRUG

Azithromycin

Azithromycin 250 mg tablet; take 2 tablets by mouth on the first day, then 1 tablet by mouth from Days 2 to 5

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Outpatients presenting with an exacerbation of chronic bronchitis including: chronic bronchitis with obstructive respiratory disorders documented by a forced expiratory volume of below 80% and higher than 35% of the theoretical value, within the previous 12 months; and thought to be of infectious origin

Exclusion Criteria

* Patient not presenting with the associated signs of an exacerbation
* Patient presenting with clinical signs suggestive of pneumonopathy at inclusion
* Patient requiring hospitalisation in intensive care
Minimum Eligible Age

36 Years

Maximum Eligible Age

74 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

Anzin, , France

Site Status

Pfizer Investigational Site

Avignon, , France

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Pfizer Investigational Site

Avignon, , France

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Pfizer Investigational Site

Dijon, , France

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Pfizer Investigational Site

Escaudain, , France

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Pfizer Investigational Site

Équeurdreville-Hainneville, , France

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Pfizer Investigational Site

Le Grand-Quevilly, , France

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Pfizer Investigational Site

Les Lilas, , France

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Pfizer Investigational Site

Lyon, , France

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Pfizer Investigational Site

Mantes-la-Jolie, , France

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Pfizer Investigational Site

Maromme, , France

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Pfizer Investigational Site

Marseille, , France

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Pfizer Investigational Site

Maubeuge, , France

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Pfizer Investigational Site

Mont-Saint-Martin, , France

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Pfizer Investigational Site

Nancy, , France

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Pfizer Investigational Site

Paris, , France

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Pfizer Investigational Site

Paris, , France

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Pfizer Investigational Site

Paris, , France

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Pfizer Investigational Site

Paris, , France

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Pfizer Investigational Site

Saint-Aulaire, , France

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Pfizer Investigational Site

Savigny, , France

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Pfizer Investigational Site

Soissons, , France

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Pfizer Investigational Site

Tourcoing, , France

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Pfizer Investigational Site

Tulette, , France

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Pfizer Investigational Site

Valenton, , France

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Pfizer Investigational Site

VAUX S/ Seine, , France

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Pfizer Investigational Site

Villejuif, , France

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Pfizer Investigational Site

Vincennes, , France

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Pfizer Investigational Site

Vitry, , France

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Pfizer Investigational Site

Wattrelos, , France

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Pfizer Investigational Site

Yerres, , France

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Countries

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France

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661045&StudyName=A%20Multicentre%2C%20Randomised%2C%20Open-Label%20Study%20To%20Compare%20The%20Efficacy%20And%20Safety%20Of%20Azithromycin%20For%205%20Days%20With%20Those%20Of%20Amoxicillin-

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

Other Identifiers

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A0661045

Identifier Type: -

Identifier Source: org_study_id