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

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).

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

Study Overview

• Status: Completed
• Conditions: Chronic Bronchitis
• Intervention / Treatment: Other: Azithromycin SR Placebo; Drug: Azithromycin SR; Other: Moxifloxacin Placebo; Drug: Moxifloxacin

• Study Type: Interventional
• Enrollment (Actual): 398
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100034
    • Pfizer Investigational Site
  • Beijing, China, 100083
    • Pfizer Investigational Site
  • Chongqing, China, 400016
    • Pfizer Investigational Site
  • Chongqing, China, 400037
    • Pfizer Investigational Site
  • Hangzhou, China, 310003
    • Pfizer Investigational Site
  • Shanghai, China, 200025
    • Pfizer Investigational Site
  • Shanghai, China, 200040
    • Pfizer Investigational Site
  • Shanghai, China, 200080
    • Pfizer Investigational Site
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Pfizer Investigational Site
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Pfizer Investigational Site
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Pfizer Investigational Site
  • Liaoning
    • Shenyang, Liaoning, China, 110016
      • Pfizer Investigational Site
  • Shanxi
    • Xi'an, Shanxi, China, 710032
      • Pfizer Investigational Site
    • Xi'an, Shanxi, China, 710061
      • Pfizer Investigational Site
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Pfizer Investigational Site
• Malaysia
  • Kuala Lumpur
    • Cheras, Kuala Lumpur, Malaysia, 56000
      • Pfizer Investigational Site
    • Lembah Pantai, Kuala Lumpur, Malaysia, 50603
      • Pfizer Investigational Site
• Philippines
  • Manila, Philippines, 1000
    • Pfizer Investigational Site
  • Manila, Philippines, 1008
    • Pfizer Investigational Site
  • Quezon City, Philippines, 1100
    • Pfizer Investigational Site
  • Quezon City, Philippines, 1104
    • Pfizer Investigational Site
• Singapore
  • Singapore, Singapore, 169608
    • Pfizer Investigational Site
  • Singapore, Singapore, 308433
    • Pfizer Investigational Site
• Taiwan
  • Taichung, Taiwan, 40705
    • Pfizer Investigational Site
  • Taichung, Taiwan, 404
    • Pfizer Investigational Site
  • Taipei, Taiwan, 100
    • Pfizer Investigational Site
  • Taipei
    • NeiHu, Taipei, Taiwan, 114
      • Pfizer Investigational Site
  • Taoyuan Hsien
    • Kuei Shan Hsiang, Taoyuan Hsien, Taiwan, 333
      • Pfizer Investigational Site
• Thailand
  • Bangkok, Thailand, 10700
    • Pfizer Investigational Site
  • Bangkok, Thailand, 10110
    • Pfizer Investigational Site
  • Chiang Mai, Thailand, 50200
    • Pfizer Investigational Site
  • Khon Kaen, Thailand, 40002
    • Pfizer Investigational Site
  • Bangkok
    • Vachira Dusit, Bangkok, Thailand, 10330
      • Pfizer Investigational Site
  • Chiangmai
    • Maerim, Chiangmai, Thailand, 50180
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Other: Azithromycin SR Placebo; single dose, oral.; Drug: Azithromycin SR; single dose 2.0 g oral
Active Comparator: 2	Other: Moxifloxacin Placebo; 1 capsule once daily for 5 days; Drug: Moxifloxacin; 1 X 400mg capsule once daily for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Test of Cure (TOC) Visit (Day 12-19)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Test of Cure (TOC) Visit (Day 12-19)
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	Test of Cure (TOC) Visit (Day 12-19)
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	Test of Cure (TOC) Visit (Day 12-19)
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.	Number of Days
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	Test of Cure (TOC) Visit (Day 12-19)
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	Test of Cure (TOC) Visit (Day 12-19)
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	Test of Cure (TOC) Visit (Day 12-19)
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	Test of Cure (TOC) Visit (Day 12-19)

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: November 14, 2005
• First Submitted That Met QC Criteria: November 14, 2005
• First Posted (Estimate): November 16, 2005

Study Record Updates

• Last Update Posted (Estimate): November 11, 2009
• Last Update Submitted That Met QC Criteria: November 3, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: Azithromycin SR; Moxifloxacin; Acute exacerbation of chronic bronchitis (AECB)
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Bronchial Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Acute Disease; Bronchitis; Bronchitis, Chronic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Azithromycin
• Other Study ID Numbers: A0661147