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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00649831

Enrollment

250

Registered

2008-04-01

Start date

2002-10-31

Completion date

2003-06-30

Last updated

2008-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchitis, Chronic

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.

Interventions

DRUGAmoxicillin/clavulinic acid

amoxicillin/clavulinic acid 500 mg/62.5 mg tablet; take 2 tablets by mouth twice daily (BID) for 10 days

DRUGAzithromycin

Azithromycin 250 mg tablet; take 2 tablets by mouth on the first day, then 1 tablet by mouth from Days 2 to 5

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

36 Years to 74 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To assess clinical efficacy (clinical recovery or clinical failure)	Day 30

Secondary

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026