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 - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00649831

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 III

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:

MedlinePlus related topics: Chronic Bronchitis

Drug Information available for: Amoxicillin Amoxicillin sodium Clavulanic acid Amoxicillin trihydrate Amoxicillin-potassium clavulanate combination Azithromycin

U.S. FDA Resources

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:

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

Contacts and Locations

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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

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
Acute Disease
Bronchitis, Chronic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Pulmonary Disease, Chronic Obstructive

Amoxicillin
Clavulanic Acids
Clavulanic Acid
Azithromycin
Amoxicillin-Potassium Clavulanate Combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012