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
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
1 other identifier
interventional
250
1 country
31
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2002
Shorter than P25 for phase_3
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 27, 2008
CompletedFirst Posted
Study publicly available on registry
April 1, 2008
CompletedOctober 21, 2008
October 1, 2008
March 27, 2008
October 20, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
To assess clinical efficacy (clinical recovery or clinical failure)
Day 30
Secondary Outcomes (2)
Number of exacerbations
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)
continuous
Study Arms (2)
Group 2
ACTIVE COMPARATORGroup 1
ACTIVE COMPARATORInterventions
amoxicillin/clavulinic acid 500 mg/62.5 mg tablet; take 2 tablets by mouth twice daily (BID) for 10 days
Azithromycin 250 mg tablet; take 2 tablets by mouth on the first day, then 1 tablet by mouth from Days 2 to 5
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patient not presenting with the associated signs of an exacerbation
- Patient requiring hospitalisation in intensive care
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (31)
Pfizer Investigational Site
Anzin, 59410, France
Pfizer Investigational Site
Avignon, 84 000, France
Pfizer Investigational Site
Avignon, 84000, France
Pfizer Investigational Site
Dijon, 21000, France
Pfizer Investigational Site
Escaudain, 59 124, France
Pfizer Investigational Site
Équeurdreville-Hainneville, 50120, France
Pfizer Investigational Site
Le Grand-Quevilly, 76120, France
Pfizer Investigational Site
Les Lilas, 93 260, France
Pfizer Investigational Site
Lyon, 69001, France
Pfizer Investigational Site
Mantes-la-Jolie, 78200, France
Pfizer Investigational Site
Maromme, 76150, France
Pfizer Investigational Site
Marseille, 13 008, France
Pfizer Investigational Site
Maubeuge, 59600, France
Pfizer Investigational Site
Mont-Saint-Martin, 54350, France
Pfizer Investigational Site
Nancy, 54000, France
Pfizer Investigational Site
Paris, 75 016, France
Pfizer Investigational Site
Paris, 75012, France
Pfizer Investigational Site
Paris, 75017, France
Pfizer Investigational Site
Paris, 75020, France
Pfizer Investigational Site
Saint-Aulaire, 19 130, France
Pfizer Investigational Site
Savigny, 91600, France
Pfizer Investigational Site
Soissons, 02 200, France
Pfizer Investigational Site
Tourcoing, 59200, France
Pfizer Investigational Site
Tulette, 26 790, France
Pfizer Investigational Site
Valenton, 94460, France
Pfizer Investigational Site
VAUX S/ Seine, 78740, France
Pfizer Investigational Site
Villejuif, 94800, France
Pfizer Investigational Site
Vincennes, 94300, France
Pfizer Investigational Site
Vitry, 94 400, France
Pfizer Investigational Site
Wattrelos, 59150, France
Pfizer Investigational Site
Yerres, 91330, France
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 27, 2008
First Posted
April 1, 2008
Study Start
October 1, 2002
Study Completion
June 1, 2003
Last Updated
October 21, 2008
Record last verified: 2008-10