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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00254566
First received: November 14, 2005
Last updated: November 3, 2009
Last verified: November 2009
  Purpose

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


Condition Intervention Phase
Chronic Bronchitis
Other: Moxifloxacin Placebo
Drug: Moxifloxacin
Other: Azithromycin SR Placebo
Drug: Azithromycin SR
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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).

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Clinical Cure (Success) at Test of Cure Visit(Clinical Per Protocol Population) [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Clinical Cure (Success) at Test of Cure Visit (Full Analysis Set) [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ] [ Designated as safety issue: No ]
  • Percentage of Clinical Cure (Success)at Test of Cure Visit(Clinically Eligible Set) [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ] [ Designated as safety issue: No ]
  • Percentage of Bacteriologic Response at Test of Cure Visit [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ] [ Designated as safety issue: No ]
  • Time Taken for First Quartile (25%) of Subjects to Have AECB Recurrence [ Time Frame: Number of Days ] [ Designated as safety issue: No ]
  • Change From Baseline in Clinical COPD Questionnaire(CCQ)Total Score [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ] [ Designated as safety issue: No ]
  • Change From Baseline in Clinical COPD Questionnaire(CCQ)Symptoms Score [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ] [ Designated as safety issue: No ]
  • Change From Baseline in Clinical COPD Questionnaire(CCQ)Functional State Score [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ] [ Designated as safety issue: No ]
  • Change From Baseline in Clinical COPD Questionnaire(CCQ)Mental State Score [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ] [ Designated as safety issue: No ]

Enrollment: 398
Study Start Date: February 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254566

  Show 34 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00254566     History of Changes
Other Study ID Numbers: A0661147
Study First Received: November 14, 2005
Results First Received: July 22, 2009
Last Updated: November 3, 2009
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Pfizer:
Azithromycin SR; Moxifloxacin; Acute exacerbation of chronic bronchitis (AECB)

Additional relevant MeSH terms:
Bronchitis
Bronchitis, Chronic
Pulmonary Disease, Chronic Obstructive
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Azithromycin
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2014