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

October 20, 2008 updated by: Pfizer

Azithromycin (Zithromax®) 5 Days Versus Amoxicillin-Clavulanic Acid (Augmentin®): Multicentre, Randomised, Open-Label Study To Compare The Clinical Efficacy And Safety Of Azithromycin With Those Of Amoxicillin-Clavulanic Acid In Patients Presenting With An Exacerbation Of Chronic Bronchitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

250

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

  • France
      • Anzin, France, 59410
        • Pfizer Investigational Site
      • Avignon, France, 84 000
        • Pfizer Investigational Site
      • Avignon, France, 84000
        • Pfizer Investigational Site
      • Dijon, France, 21000
        • Pfizer Investigational Site
      • Equeurdreville Hainneville, France, 50120
        • Pfizer Investigational Site
      • Escaudain, France, 59 124
        • Pfizer Investigational Site
      • Le Grand Quevilly, France, 76120
        • Pfizer Investigational Site
      • Les Lilas, France, 93 260
        • Pfizer Investigational Site
      • Lyon, France, 69001
        • Pfizer Investigational Site
      • Mantes La Jolie, France, 78200
        • Pfizer Investigational Site
      • Maromme, France, 76150
        • Pfizer Investigational Site
      • Marseille, France, 13 008
        • Pfizer Investigational Site
      • Maubeuge, France, 59600
        • Pfizer Investigational Site
      • Mont Saint Martin, France, 54350
        • Pfizer Investigational Site
      • Nancy, France, 54000
        • Pfizer Investigational Site
      • Paris, France, 75020
        • Pfizer Investigational Site
      • Paris, France, 75012
        • Pfizer Investigational Site
      • Paris, France, 75017
        • Pfizer Investigational Site
      • Paris, France, 75 016
        • Pfizer Investigational Site
      • Saint Aulaire, France, 19 130
        • Pfizer Investigational Site
      • Savigny, France, 91600
        • Pfizer Investigational Site
      • Soissons, France, 02 200
        • Pfizer Investigational Site
      • Tourcoing, France, 59200
        • Pfizer Investigational Site
      • Tulette, France, 26 790
        • Pfizer Investigational Site
      • Valenton, France, 94460
        • Pfizer Investigational Site
      • Vaux S/ Seine, France, 78740
        • Pfizer Investigational Site
      • Villejuif, France, 94800
        • Pfizer Investigational Site
      • Vincennes, France, 94300
        • Pfizer Investigational Site
      • Vitry, France, 94 400
        • Pfizer Investigational Site
      • Wattrelos, France, 59150
        • Pfizer Investigational Site
      • Yerres, France, 91330
        • 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

36 years to 74 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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:

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

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group 2
Drug: Amoxicillin/clavulinic acid
amoxicillin/clavulinic acid 500 mg/62.5 mg tablet; take 2 tablets by mouth twice daily (BID) for 10 days
ACTIVE_COMPARATOR: Group 1
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess clinical efficacy (clinical recovery or clinical failure)
Time Frame: Day 30
Day 30

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of exacerbations
Time Frame: Day 30 to Day 90
Day 30 to Day 90
Bacteriological monitoring (a descriptive analysis of streptococci in the bacterial flora and their sensitivity to antibiotics at the different collections of sputum)
Time Frame: continuous
continuous

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

October 1, 2002

Study Completion (ACTUAL)

June 1, 2003

Study Registration Dates

First Submitted

March 27, 2008

First Submitted That Met QC Criteria

March 27, 2008

First Posted (ESTIMATE)

April 1, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 21, 2008

Last Update Submitted That Met QC Criteria

October 20, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0661045

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.

Clinical Trials on Bronchitis, Chronic

Clinical Trials on Amoxicillin/clavulinic acid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe