Bronchitis, Chronic Clinical Trial
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
Verified date | October 2008 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | Unknown: |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 250 |
Est. completion date | June 2003 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 36 Years to 74 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Pfizer Investigational Site | Anzin | |
France | Pfizer Investigational Site | Avignon | |
France | Pfizer Investigational Site | Avignon | |
France | Pfizer Investigational Site | Dijon | |
France | Pfizer Investigational Site | Equeurdreville Hainneville | |
France | Pfizer Investigational Site | Escaudain | |
France | Pfizer Investigational Site | Le Grand Quevilly | |
France | Pfizer Investigational Site | Les Lilas | |
France | Pfizer Investigational Site | Lyon | |
France | Pfizer Investigational Site | Mantes La Jolie | |
France | Pfizer Investigational Site | Maromme | |
France | Pfizer Investigational Site | Marseille | |
France | Pfizer Investigational Site | Maubeuge | |
France | Pfizer Investigational Site | Mont Saint Martin | |
France | Pfizer Investigational Site | Nancy | |
France | Pfizer Investigational Site | Paris | |
France | Pfizer Investigational Site | Paris | |
France | Pfizer Investigational Site | Paris | |
France | Pfizer Investigational Site | Paris | |
France | Pfizer Investigational Site | Saint Aulaire | |
France | Pfizer Investigational Site | Savigny | |
France | Pfizer Investigational Site | Soissons | |
France | Pfizer Investigational Site | Tourcoing | |
France | Pfizer Investigational Site | Tulette | |
France | Pfizer Investigational Site | Valenton | |
France | Pfizer Investigational Site | Vaux S/ Seine | |
France | Pfizer Investigational Site | Villejuif | |
France | Pfizer Investigational Site | Vincennes | |
France | Pfizer Investigational Site | Vitry | |
France | Pfizer Investigational Site | Wattrelos | |
France | Pfizer Investigational Site | Yerres |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess clinical efficacy (clinical recovery or clinical failure) | Day 30 | No | |
Secondary | Number of exacerbations | Day 30 to Day 90 | No | |
Secondary | Bacteriological monitoring (a descriptive analysis of streptococci in the bacterial flora and their sensitivity to antibiotics at the different collections of sputum) | continuous | No |
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