Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00649831
First received: March 27, 2008
Last updated: October 20, 2008
Last verified: October 2008
  Purpose

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.


Condition Intervention Phase
Bronchitis, Chronic
Drug: Amoxicillin/clavulinic acid
Drug: Azithromycin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To assess clinical efficacy (clinical recovery or clinical failure) [ Time Frame: Day 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of exacerbations [ Time Frame: Day 30 to Day 90 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: October 2002
Study Completion Date: June 2003
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   36 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00649831

Locations
France
Pfizer Investigational Site
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, 75 016
Pfizer Investigational Site
Paris, France, 75012
Pfizer Investigational Site
Paris, France, 75017
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
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00649831     History of Changes
Other Study ID Numbers: A0661045
Study First Received: March 27, 2008
Last Updated: October 20, 2008
Health Authority: Unknown:

Additional relevant MeSH terms:
Bronchitis
Bronchitis, Chronic
Bronchial Diseases
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acid
Clavulanic Acids
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014