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
Phase 3
Completed
- Conditions
- Bronchitis, Chronic
- Interventions
- Drug: Amoxicillin/clavulinic acid
- Registration Number
- NCT00649831
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2 Amoxicillin/clavulinic acid - Group 1 Azithromycin -
- Primary Outcome Measures
Name Time Method To assess clinical efficacy (clinical recovery or clinical failure) Day 30
- Secondary Outcome Measures
Name Time Method Bacteriological monitoring (a descriptive analysis of streptococci in the bacterial flora and their sensitivity to antibiotics at the different collections of sputum) continuous Number of exacerbations Day 30 to Day 90
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇫🇷Yerres, France