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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

Primary Purpose

Bronchitis, Chronic

Status

Completed

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Amoxicillin/clavulinic acid

Azithromycin

About this trial

This is an interventional treatment trial for Bronchitis, Chronic

Eligibility Criteria

36 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group 2

Group 1

Arm Description

Outcomes

Primary Outcome Measures

To assess clinical efficacy (clinical recovery or clinical failure)

Secondary Outcome Measures

Number of exacerbations

Bacteriological monitoring (a descriptive analysis of streptococci in the bacterial flora and their sensitivity to antibiotics at the different collections of sputum)

Full Information

NCT ID

NCT00649831

First Posted

March 27, 2008

Last Updated

October 20, 2008

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00649831

Brief Title

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

2. Study Status

Record Verification Date

October 2008

Overall Recruitment Status

Completed

Study Start Date

October 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bronchitis, Chronic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 2

Arm Type

Active Comparator

Arm Title

Group 1

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Amoxicillin/clavulinic acid

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Azithromycin

Intervention Description

Azithromycin 250 mg tablet; take 2 tablets by mouth on the first day, then 1 tablet by mouth from Days 2 to 5

Primary Outcome Measure Information:

Title

To assess clinical efficacy (clinical recovery or clinical failure)

Time Frame

Day 30

Secondary Outcome Measure Information:

Title

Number of exacerbations

Time Frame

Day 30 to Day 90

Title

Bacteriological monitoring (a descriptive analysis of streptococci in the bacterial flora and their sensitivity to antibiotics at the different collections of sputum)

Time Frame

continuous

10. Eligibility

Sex

All

Minimum Age & Unit of Time

36 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Anzin

ZIP/Postal Code

59410

Country

France

Facility Name

Pfizer Investigational Site

City

Avignon

ZIP/Postal Code

84 000

Country

France

Facility Name

Pfizer Investigational Site

City

Avignon

ZIP/Postal Code

84000

Country

France

Facility Name

Pfizer Investigational Site

City

Dijon

ZIP/Postal Code

21000

Country

France

Facility Name

Pfizer Investigational Site

City

Equeurdreville Hainneville

ZIP/Postal Code

50120

Country

France

Facility Name

Pfizer Investigational Site

City

Escaudain

ZIP/Postal Code

59 124

Country

France

Facility Name

Pfizer Investigational Site

City

Le Grand Quevilly

ZIP/Postal Code

76120

Country

France

Facility Name

Pfizer Investigational Site

City

Les Lilas

ZIP/Postal Code

93 260

Country

France

Facility Name

Pfizer Investigational Site

City

Lyon

ZIP/Postal Code

69001

Country

France

Facility Name

Pfizer Investigational Site

City

Mantes La Jolie

ZIP/Postal Code

78200

Country

France

Facility Name

Pfizer Investigational Site

City

Maromme

ZIP/Postal Code

76150

Country

France

Facility Name

Pfizer Investigational Site

City

Marseille

ZIP/Postal Code

13 008

Country

France

Facility Name

Pfizer Investigational Site

City

Maubeuge

ZIP/Postal Code

59600

Country

France

Facility Name

Pfizer Investigational Site

City

Mont Saint Martin

ZIP/Postal Code

54350

Country

France

Facility Name

Pfizer Investigational Site

City

Nancy

ZIP/Postal Code

54000

Country

France

Facility Name

Pfizer Investigational Site

City

Paris

ZIP/Postal Code

75 016

Country

France

Facility Name

Pfizer Investigational Site

City

Paris

ZIP/Postal Code

75012

Country

France

Facility Name

Pfizer Investigational Site

City

Paris

ZIP/Postal Code

75017

Country

France

Facility Name

Pfizer Investigational Site

City

Paris

ZIP/Postal Code

75020

Country

France

Facility Name

Pfizer Investigational Site

City

Saint Aulaire

ZIP/Postal Code

19 130

Country

France

Facility Name

Pfizer Investigational Site

City

Savigny

ZIP/Postal Code

91600

Country

France

Facility Name

Pfizer Investigational Site

City

Soissons

ZIP/Postal Code

02 200

Country

France

Facility Name

Pfizer Investigational Site

City

Tourcoing

ZIP/Postal Code

59200

Country

France

Facility Name

Pfizer Investigational Site

City

Tulette

ZIP/Postal Code

26 790

Country

France

Facility Name

Pfizer Investigational Site

City

Valenton

ZIP/Postal Code

94460

Country

France

Facility Name

Pfizer Investigational Site

City

Vaux S/ Seine

ZIP/Postal Code

78740

Country

France

Facility Name

Pfizer Investigational Site

City

Villejuif

ZIP/Postal Code

94800

Country

France

Facility Name

Pfizer Investigational Site

City

Vincennes

ZIP/Postal Code

94300

Country

France

Facility Name

Pfizer Investigational Site

City

Vitry

ZIP/Postal Code

94 400

Country

France

Facility Name

Pfizer Investigational Site

City

Wattrelos

ZIP/Postal Code

59150

Country

France

Facility Name

Pfizer Investigational Site

City

Yerres

ZIP/Postal Code

91330

Country

France

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661045&StudyName=A%20Multicentre%2C%20Randomised%2C%20Open-Label%20Study%20To%20Compare%20The%20Efficacy%20And%20Safety%20Of%20Azithromycin%20For%205%20Days%20With%20Those%20Of%20Amoxicillin-

Description

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Learn more about this 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

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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

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial