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NCT00649831 Clinical Trial

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

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00649831
Other study ID # A0661045
Secondary ID
Status Completed
Phase Phase 3
First received March 27, 2008
Last updated October 20, 2008
Start date October 2002
Est. completion date June 2003

Study information
Verified date October 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Unknown:
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Amoxicillin/clavulinic acid
amoxicillin/clavulinic acid 500 mg/62.5 mg tablet; take 2 tablets by mouth twice daily (BID) for 10 days
• Azithromycin
Azithromycin 250 mg tablet; take 2 tablets by mouth on the first day, then 1 tablet by mouth from Days 2 to 5

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

France, 

Outcome
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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Terminated NCT02261350 - Post-hospitalisation Nutritional Support and Gait Speed in COPD Phase 3
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Completed NCT01077102 - Eccentric Exercise Training as Novel Rehabilitation for Chronic Obstructive Pulmonary Disease (COPD) N/A
Terminated NCT00288223 - Telithromycin in Acute Exacerbation of Chronic Bronchitis Phase 4
Completed NCT00644449 - A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Acute Symptoms of Chronic Bronchitis Phase 3
Completed NCT00423137 - Effect of BIBW 2948 BS in COPD Phase 2
Completed NCT02483637 - Safety and Feasibility Study of Rejuvenair™ for Treating Chronic Bronchitis Patients N/A
Completed NCT00932802 - Greatest International Antiinfective Trial With Avelox N/A
Completed NCT00245427 - Outcomes of Patients Not Responding to Antibiotics in the Community N/A
Completed NCT00035828 - A Blinded Study Comparing the Safety and Efficacy of a Fully Human Anti-IL8 Monoclonal Antibody (ABX-IL8) to Placebo in Patients With Chronic Bronchitis and COPD Phase 2
Completed NCT00184977 - COPD on Primary Care Treatment (COOPT) Phase 4

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