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

• ClinicalTrials.gov Identifier: NCT00254566
• Recruitment Status: Completed
• First Posted: November 16, 2005
• Results First Posted: September 2, 2009
• Last Update Posted: November 11, 2009
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: November 14, 2005
• First Posted Date: November 16, 2005
• Results First Submitted Date: July 22, 2009
• Results First Posted Date: September 2, 2009
• Last Update Posted Date: November 11, 2009
• Study Start Date: February 2006
• Actual Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 10, 2009)

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

• Original Primary Outcome Measures (submitted: November 14, 2005): Clinical Response at Test of Cure Visit

Current Secondary Outcome Measures (submitted: September 10, 2009)

• 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
• 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
• 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
• 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.
• 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
• 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
• 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
• 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

• Original Secondary Outcome Measures (submitted: November 14, 2005): Bacteriologic response at Test of cure visit Time to first recurrence of AECB Health status Safety and tolerability
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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).
• 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
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Chronic Bronchitis

Intervention

• Other: Moxifloxacin Placebo
  1 capsule once daily for 5 days
• Drug: Moxifloxacin
  1 X 400mg capsule once daily for 5 days
• Other: Azithromycin SR Placebo
  single dose, oral.
• Drug: Azithromycin SR
  single dose 2.0 g oral

Study Arms

• Experimental: 1
  Interventions:

  • Other: Azithromycin SR Placebo
  • Drug: Azithromycin SR
• Active Comparator: 2
  Interventions:

  • Other: Moxifloxacin Placebo
  • Drug: Moxifloxacin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 8, 2008): 398
• Original Enrollment (submitted: November 14, 2005): 416
• Actual Study Completion Date: August 2008
• Actual Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China, Malaysia, Philippines, Singapore, Taiwan, Thailand

Administrative Information

• NCT Number: NCT00254566
• Other Study ID Numbers: A0661147
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: November 2009