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

Condition(s) targeted: Bronchitis, Chronic

Intervention: Amoxicillin/clavulinic acid (Drug); Azithromycin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

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

Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Primary outcome: To assess clinical efficacy (clinical recovery or clinical failure)

Secondary outcome:

Number of exacerbations

Bacteriological monitoring (a descriptive analysis of streptococci in the bacterial flora and their sensitivity to antibiotics at the different collections of sputum)

Minimum age: 36 Years. Maximum age: 74 Years. Gender(s): Both.

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

Pfizer Investigational Site, PARIS 75020, France

Pfizer Investigational Site, MAUBEUGE 59600, France

Pfizer Investigational Site, VILLEJUIF 94800, France

Pfizer Investigational Site, MANTES LA JOLIE 78200, France

Pfizer Investigational Site, TOURCOING 59200, France

Pfizer Investigational Site, WATTRELOS 59150, France

Pfizer Investigational Site, MONT SAINT MARTIN 54350, France

Pfizer Investigational Site, NANCY 54000, France

Pfizer Investigational Site, VINCENNES 94300, France

Pfizer Investigational Site, VALENTON 94460, France

Pfizer Investigational Site, LYON 69001, France

Pfizer Investigational Site, Paris 75 016, France

Pfizer Investigational Site, LES LILAS 93 260, France

Pfizer Investigational Site, SOISSONS 02 200, France

Pfizer Investigational Site, TULETTE 26 790, France

Pfizer Investigational Site, PARIS 75012, France

Pfizer Investigational Site, MAROMME 76150, France

Pfizer Investigational Site, LE GRAND QUEVILLY 76120, France

Pfizer Investigational Site, ESCAUDAIN 59 124, France

Pfizer Investigational Site, VITRY 94 400, France

Pfizer Investigational Site, MARSEILLE 13 008, France

Pfizer Investigational Site, AVIGNON 84 000, France

Pfizer Investigational Site, SAINT AULAIRE 19 130, France

Pfizer Investigational Site, SAVIGNY 91600, France

Pfizer Investigational Site, VAUX S/ SEINE 78740, France

Pfizer Investigational Site, DIJON 21000, France

Pfizer Investigational Site, YERRES 91330, France

Pfizer Investigational Site, AVIGNON 84000, France

Pfizer Investigational Site, PARIS 75017, France

Pfizer Investigational Site, EQUEURDREVILLE HAINNEVILLE 50120, France

Pfizer Investigational Site, ANZIN 59410, France

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

Starting date: October 2002
Ending date: June 2003
Last updated: March 27, 2008