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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00649831

Collaborator

(none)

250

Enrollment

Locations

Arms

Duration (Months)

8.1

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bronchitis, Chronic	Drug: Amoxicillin/clavulinic acid Drug: Azithromycin	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Oct 1, 2002

Actual Study Completion Date :

Jun 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 2	Drug: Amoxicillin/clavulinic acid amoxicillin/clavulinic acid 500 mg/62.5 mg tablet; take 2 tablets by mouth twice daily (BID) for 10 days
Active Comparator: Group 1	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

Arm

Intervention/Treatment

Active Comparator: Group 2

Drug: Amoxicillin/clavulinic acid

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

Active Comparator: Group 1

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

Outcome Measures

Primary Outcome Measures

To assess clinical efficacy (clinical recovery or clinical failure) [Day 30]

Secondary Outcome Measures

Number of exacerbations [Day 30 to Day 90]
Bacteriological monitoring (a descriptive analysis of streptococci in the bacterial flora and their sensitivity to antibiotics at the different collections of sputum) [continuous]

Eligibility Criteria

Criteria

Ages Eligible for Study:

36 Years to 74 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Pfizer Investigational Site	Anzin	France	59410
2	Pfizer Investigational Site	Avignon	France	84 000
3	Pfizer Investigational Site	Avignon	France	84000
4	Pfizer Investigational Site	Dijon	France	21000
5	Pfizer Investigational Site	Equeurdreville Hainneville	France	50120
6	Pfizer Investigational Site	Escaudain	France	59 124
7	Pfizer Investigational Site	Le Grand Quevilly	France	76120
8	Pfizer Investigational Site	Les Lilas	France	93 260
9	Pfizer Investigational Site	Lyon	France	69001
10	Pfizer Investigational Site	Mantes La Jolie	France	78200
11	Pfizer Investigational Site	Maromme	France	76150
12	Pfizer Investigational Site	Marseille	France	13 008
13	Pfizer Investigational Site	Maubeuge	France	59600
14	Pfizer Investigational Site	Mont Saint Martin	France	54350
15	Pfizer Investigational Site	Nancy	France	54000
16	Pfizer Investigational Site	Paris	France	75 016
17	Pfizer Investigational Site	Paris	France	75012
18	Pfizer Investigational Site	Paris	France	75017
19	Pfizer Investigational Site	Paris	France	75020
20	Pfizer Investigational Site	Saint Aulaire	France	19 130
21	Pfizer Investigational Site	Savigny	France	91600
22	Pfizer Investigational Site	Soissons	France	02 200
23	Pfizer Investigational Site	Tourcoing	France	59200
24	Pfizer Investigational Site	Tulette	France	26 790
25	Pfizer Investigational Site	Valenton	France	94460
26	Pfizer Investigational Site	Vaux S/ Seine	France	78740
27	Pfizer Investigational Site	Villejuif	France	94800
28	Pfizer Investigational Site	Vincennes	France	94300
29	Pfizer Investigational Site	Vitry	France	94 400
30	Pfizer Investigational Site	Wattrelos	France	59150
31	Pfizer Investigational Site	Yerres	France	91330