A Trial To Evaluate Two Antibiotics For The Treatment Of Acute Exacerbation Of Chronic Bronchitis (AECB)

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Moxifloxacin Placebo

Moxifloxacin

Azithromycin SR Placebo

Azithromycin SR

About this trial

This is an interventional treatment trial for Chronic Bronchitis focused on measuring Azithromycin SR; Moxifloxacin; Acute exacerbation of chronic bronchitis (AECB)

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of chronic bronchitis (chronic cough and sputum production on most days for three consecutive months for more than two consecutive years) and clinical evidence of AECB as demonstrated by both the following symptoms: Production of purulent sputum as defined by Gram stained sputum specimen Presence of all of the following: Increased sputum production Increased dyspnea Increased cough At least two exacerbations of AECB in the past 12 months Documented FEV1 less than 80% of predicted Exclusion Criteria: A chest radiograph consistent with pneumonia Treatment with any systemic antibiotic within the twenty-one days prior to study entry or those with a chance of receiving other systemic antibiotics during study participation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Clinical Cure (Success) at Test of Cure Visit(Clinical Per Protocol Population)

Cure=Signs&symptoms(S&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S&S of acute infection persisted/worsened,new clinical S&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub

Secondary Outcome Measures

Percentage of Clinical Cure (Success) at Test of Cure Visit (Full Analysis Set)

Clinical response (Cure vs Failure) at the TOC visit for the Full Analysis Set (FAS), Cure=Signs&symptoms(S&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S&S of acute infection persisted/worsened,new clinical S&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub

Percentage of Clinical Cure (Success)at Test of Cure Visit(Clinically Eligible Set)

Clinical Response at TOC Visit for clinically Eligible Subjects, Cure=Signs&symptoms(S&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S&S of acute infection persisted/worsened,new clinical S&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub

Percentage of Bacteriologic Response at Test of Cure Visit

Bacteriogical response assessed on per pathogen basis for Bacteriologic Per Protcol (BPP) set at TOC Visit. If no repeat culture, response is presumed from sponsor assessment of clinical response. Eradication =# of pathogens eradicated at TOC/N; Persistence =# of pathogens persistent at TOC/N; N=# of unique pathogens identified at baseline

Time Taken for First Quartile (25%) of Subjects to Have AECB Recurrence

Subject is considered to have AECB recurrence if they had a clinical response of cure at the TOC visit and then met the definition of AECB during the follow-up period.

Change From Baseline in Clinical COPD Questionnaire(CCQ)Total Score

CCQ was developed to measure health status of Chronic obstructive pulmonary disease (COPD) subjects. 10 items divided into 3 domains: symtoms, functional state, and mental state. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely symptomatic/totally limited; change=mean score at observation minus mean score at baseline

Change From Baseline in Clinical COPD Questionnaire(CCQ)Symptoms Score

1 of 3 domains that combined into the CCQ Total score. Items 1,2,5,and 6 address symptoms. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely symptomatic; change=mean score at observation minus mean score at baseline

Change From Baseline in Clinical COPD Questionnaire(CCQ)Functional State Score

1 of 3 domains that combined into the CCQ Total score. Items 7,8,9, and 10 address functional state. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely; change=mean score at observation minus mean score at baseline

Change From Baseline in Clinical COPD Questionnaire(CCQ)Mental State Score

1 of 3 domains that combined into the CCQ Total score. Items 3 and 4 address mental state. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely; change=mean score at observation minus mean score at baseline

Full Information

NCT ID

NCT00254566

First Posted

November 14, 2005

Last Updated

November 3, 2009

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00254566

Brief Title

A Trial To Evaluate Two Antibiotics For The Treatment Of Acute Exacerbation Of Chronic Bronchitis (AECB)

Official Title

A Phase 3B Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial To Evaluate The Efficacy and Safety Of Azithromycin SR (Microspheres Formulation) Versus Moxifloxacin For The Treatment Of Acute Exacerbation Of Chronic Bronchitis (AECB).

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Completed

Study Start Date

February 2006 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

This trial is a research drug study to compare the effects of two antibiotics for the treatment of acute exacerbation of chronic bronchitis

6. Conditions and Keywords

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

Chronic Bronchitis

Keywords

Azithromycin SR; Moxifloxacin; Acute exacerbation of chronic bronchitis (AECB)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

398 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1

Arm Type

Experimental

Arm Title

2

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Moxifloxacin Placebo

Intervention Description

1 capsule once daily for 5 days

Intervention Type

Drug

Intervention Name(s)

Moxifloxacin

Intervention Description

1 X 400mg capsule once daily for 5 days

Intervention Type

Other

Intervention Name(s)

Azithromycin SR Placebo

Intervention Description

single dose, oral.

Intervention Type

Drug

Intervention Name(s)

Azithromycin SR

Intervention Description

single dose 2.0 g oral

Primary Outcome Measure Information:

Title

Percentage of Clinical Cure (Success) at Test of Cure Visit(Clinical Per Protocol Population)

Description

Cure=Signs&symptoms(S&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S&S of acute infection persisted/worsened,new clinical S&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub

Time Frame

Test of Cure (TOC) Visit (Day 12-19)

Secondary Outcome Measure Information:

Title

Percentage of Clinical Cure (Success) at Test of Cure Visit (Full Analysis Set)

Description

Clinical response (Cure vs Failure) at the TOC visit for the Full Analysis Set (FAS), Cure=Signs&symptoms(S&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S&S of acute infection persisted/worsened,new clinical S&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub

Time Frame

Test of Cure (TOC) Visit (Day 12-19)

Title

Percentage of Clinical Cure (Success)at Test of Cure Visit(Clinically Eligible Set)

Description

Clinical Response at TOC Visit for clinically Eligible Subjects, Cure=Signs&symptoms(S&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S&S of acute infection persisted/worsened,new clinical S&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub

Time Frame

Test of Cure (TOC) Visit (Day 12-19)

Title

Percentage of Bacteriologic Response at Test of Cure Visit

Description

Bacteriogical response assessed on per pathogen basis for Bacteriologic Per Protcol (BPP) set at TOC Visit. If no repeat culture, response is presumed from sponsor assessment of clinical response. Eradication =# of pathogens eradicated at TOC/N; Persistence =# of pathogens persistent at TOC/N; N=# of unique pathogens identified at baseline

Time Frame

Test of Cure (TOC) Visit (Day 12-19)

Title

Time Taken for First Quartile (25%) of Subjects to Have AECB Recurrence

Description

Subject is considered to have AECB recurrence if they had a clinical response of cure at the TOC visit and then met the definition of AECB during the follow-up period.

Time Frame

Number of Days

Title

Change From Baseline in Clinical COPD Questionnaire(CCQ)Total Score

Description

CCQ was developed to measure health status of Chronic obstructive pulmonary disease (COPD) subjects. 10 items divided into 3 domains: symtoms, functional state, and mental state. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely symptomatic/totally limited; change=mean score at observation minus mean score at baseline

Time Frame

Test of Cure (TOC) Visit (Day 12-19)

Title

Change From Baseline in Clinical COPD Questionnaire(CCQ)Symptoms Score

Description

1 of 3 domains that combined into the CCQ Total score. Items 1,2,5,and 6 address symptoms. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely symptomatic; change=mean score at observation minus mean score at baseline

Time Frame

Test of Cure (TOC) Visit (Day 12-19)

Title

Change From Baseline in Clinical COPD Questionnaire(CCQ)Functional State Score

Description

1 of 3 domains that combined into the CCQ Total score. Items 7,8,9, and 10 address functional state. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely; change=mean score at observation minus mean score at baseline

Time Frame

Test of Cure (TOC) Visit (Day 12-19)

Title

Change From Baseline in Clinical COPD Questionnaire(CCQ)Mental State Score

Description

1 of 3 domains that combined into the CCQ Total score. Items 3 and 4 address mental state. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely; change=mean score at observation minus mean score at baseline

Time Frame

Test of Cure (TOC) Visit (Day 12-19)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Diagnosis of chronic bronchitis (chronic cough and sputum production on most days for three consecutive months for more than two consecutive years) and clinical evidence of AECB as demonstrated by both the following symptoms: Production of purulent sputum as defined by Gram stained sputum specimen Presence of all of the following: Increased sputum production Increased dyspnea Increased cough At least two exacerbations of AECB in the past 12 months Documented FEV1 less than 80% of predicted Exclusion Criteria: A chest radiograph consistent with pneumonia Treatment with any systemic antibiotic within the twenty-one days prior to study entry or those with a chance of receiving other systemic antibiotics during study participation

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

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

Facility Name

Pfizer Investigational Site

City

Shijiazhuang

State/Province

Hebei

ZIP/Postal Code

050000

Country

China

Facility Name

Pfizer Investigational Site

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210002

Country

China

Facility Name

Pfizer Investigational Site

City

Shenyang

State/Province

Liaoning

ZIP/Postal Code

110016

Country

China

Facility Name

Pfizer Investigational Site

City

Xi'an

State/Province

Shanxi

ZIP/Postal Code

710032

Country

China

Facility Name

Pfizer Investigational Site

City

Xi'an

State/Province

Shanxi

ZIP/Postal Code

710061

Country

China

Facility Name

Pfizer Investigational Site

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

Facility Name

Pfizer Investigational Site

City

Beijing

ZIP/Postal Code

100034

Country

China

Facility Name

Pfizer Investigational Site

City

Beijing

ZIP/Postal Code

100083

Country

China

Facility Name

Pfizer Investigational Site

City

Chongqing

ZIP/Postal Code

400016

Country

China

Facility Name

Pfizer Investigational Site

City

Chongqing

ZIP/Postal Code

400037

Country

China

Facility Name

Pfizer Investigational Site

City

Hangzhou

ZIP/Postal Code

310003

Country

China

Facility Name

Pfizer Investigational Site

City

Shanghai

ZIP/Postal Code

200025

Country

China

Facility Name

Pfizer Investigational Site

City

Shanghai

ZIP/Postal Code

200040

Country

China

Facility Name

Pfizer Investigational Site

City

Shanghai

ZIP/Postal Code

200080

Country

China

Facility Name

Pfizer Investigational Site

City

Cheras

State/Province

Kuala Lumpur

ZIP/Postal Code

56000

Country

Malaysia

Facility Name

Pfizer Investigational Site

City

Lembah Pantai

State/Province

Kuala Lumpur

ZIP/Postal Code

50603

Country

Malaysia

Facility Name

Pfizer Investigational Site

City

Manila

ZIP/Postal Code

1000

Country

Philippines

Facility Name

Pfizer Investigational Site

City

Manila

ZIP/Postal Code

1008

Country

Philippines

Facility Name

Pfizer Investigational Site

City

Quezon City

ZIP/Postal Code

1100

Country

Philippines

Facility Name

Pfizer Investigational Site

City

Quezon City

ZIP/Postal Code

1104

Country

Philippines

Facility Name

Pfizer Investigational Site

City

Singapore

ZIP/Postal Code

169608

Country

Singapore

Facility Name

Pfizer Investigational Site

City

Singapore

ZIP/Postal Code

308433

Country

Singapore

Facility Name

Pfizer Investigational Site

City

NeiHu

State/Province

Taipei

ZIP/Postal Code

114

Country

Taiwan

Facility Name

Pfizer Investigational Site

City

Kuei Shan Hsiang

State/Province

Taoyuan Hsien

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Pfizer Investigational Site

City

Taichung

ZIP/Postal Code

404

Country

Taiwan

Facility Name

Pfizer Investigational Site

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

Pfizer Investigational Site

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

Pfizer Investigational Site

City

Vachira Dusit

State/Province

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Pfizer Investigational Site

City

Maerim

State/Province

Chiangmai

ZIP/Postal Code

50180

Country

Thailand

Facility Name

Pfizer Investigational Site

City

Bangkok

ZIP/Postal Code

10110

Country

Thailand

Facility Name

Pfizer Investigational Site

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

Pfizer Investigational Site

City

Chiang Mai

ZIP/Postal Code

50200

Country

Thailand

Facility Name

Pfizer Investigational Site

City

Khon Kaen

ZIP/Postal Code

40002

Country

Thailand

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661147&StudyName=A%20Trial%20To%20Evaluate%20Two%20Antibiotics%20For%20The%20Treatment%20Of%20Acute%20Exacerbation%20Of%20Chronic%20Bronchitis%20%28AECB%29

Description

To obtain contact information for a study center near you, click here.

Chronic Bronchitis

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