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Completed

NCT Number: NCT00254566

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

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

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Key information

Conditions

Chronic Bronchitis Bronchial Diseases Bronchitis Bronchitis, Chronic Chronic Disease Disease Attributes Infections Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moxifloxacin Placebo

Other

1 capsule once daily for 5 days

moxifloxacin

Drug

1 X 400mg capsule once daily for 5 days

Azithromycin SR Placebo

Other

single dose, oral.

Azithromycin SR

Drug

single dose 2.0 g oral

Primary outcomes

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

    Time frame: Test of Cure (TOC) Visit (Day 12-19)

    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 outcomes

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

    Time frame: Test of Cure (TOC) Visit (Day 12-19)

    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

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

    Time frame: Test of Cure (TOC) Visit (Day 12-19)

    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

  3. Percentage of Bacteriologic Response at Test of Cure Visit

    Time frame: Test of Cure (TOC) Visit (Day 12-19)

    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

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

    Time frame: Number of Days

    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.

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

    Time frame: Test of Cure (TOC) Visit (Day 12-19)

    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

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

    Time frame: Test of Cure (TOC) Visit (Day 12-19)

    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

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

    Time frame: Test of Cure (TOC) Visit (Day 12-19)

    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

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

    Time frame: Test of Cure (TOC) Visit (Day 12-19)

    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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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).

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Nov 16, 2005
Registry last updated
Nov 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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