Clinical trial NCT00649831: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bronchitis, Chronic
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 250
Sex: ALL
Minimum age (years): 36
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: To assess clinical efficacy (clinical recovery or clinical failure)
timeFrame: Day 30
Secondary outcomes:
measure: Number of exacerbations
timeFrame: Day 30 to Day 90
measure: Bacteriological monitoring (a descriptive analysis of streptococci in the bacterial flora and their sensitivity to antibiotics at the different collections of sputum)
timeFrame: continuous
Other outcomes:
Locations:
city: Anzin
country: France
facility: Pfizer Investigational Site
city: Avignon
country: France
facility: Pfizer Investigational Site
city: Avignon
country: France
facility: Pfizer Investigational Site
city: Dijon
country: France
facility: Pfizer Investigational Site
city: Equeurdreville Hainneville
country: France
facility: Pfizer Investigational Site
city: Escaudain
country: France
facility: Pfizer Investigational Site
city: Le Grand Quevilly
country: France
facility: Pfizer Investigational Site
city: Les Lilas
country: France
facility: Pfizer Investigational Site
city: Lyon
country: France
facility: Pfizer Investigational Site
city: Mantes La Jolie
country: France
facility: Pfizer Investigational Site
city: Maromme
country: France
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
city: Maubeuge
country: France
facility: Pfizer Investigational Site
city: Mont Saint Martin
country: France
facility: Pfizer Investigational Site
city: Nancy
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Saint Aulaire
country: France
facility: Pfizer Investigational Site
city: Savigny
country: France
facility: Pfizer Investigational Site
city: Soissons
country: France
facility: Pfizer Investigational Site
city: Tourcoing
country: France
facility: Pfizer Investigational Site
city: Tulette
country: France
facility: Pfizer Investigational Site
city: Valenton
country: France
facility: Pfizer Investigational Site
city: Vaux S/ Seine
country: France
facility: Pfizer Investigational Site
city: Villejuif
country: France
facility: Pfizer Investigational Site
city: Vincennes
country: France
facility: Pfizer Investigational Site
city: Vitry
country: France
facility: Pfizer Investigational Site
city: Wattrelos
country: France
facility: Pfizer Investigational Site
city: Yerres
country: France
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: