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”

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.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Group 2
• Active Comparator: Group 1

Primary Measures

• To assess clinical efficacy (clinical recovery or clinical failure)
  • Time Frame: Day 30
    Safety Issue?: No

Secondary Measures

• Number of exacerbations
  • Time Frame: Day 30 to Day 90
    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
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 36 Years

Maximum Age for this Clinical Trial: 74 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00649831

Study ID Number: A0661045

ClinicalTrials.gov Identifier: NCT00649831

Health Authority: Unknown:

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