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Trial record 31 of 43 for:    "Bronchial Disease" | "Azithromycin"

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

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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:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE November 14, 2005
First Posted Date  ICMJE November 16, 2005
Results First Submitted Date  ICMJE July 22, 2009
Results First Posted Date  ICMJE September 2, 2009
Last Update Posted Date November 11, 2009
Study Start Date  ICMJE February 2006
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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) ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 14, 2005)
Clinical Response at Test of Cure Visit
Change History Complete list of historical versions of study NCT00254566 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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) ]
  • Percentage of Clinical Cure (Success)at Test of Cure Visit(Clinically Eligible Set) [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ]
  • Percentage of Bacteriologic Response at Test of Cure Visit [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ]
  • Time Taken for First Quartile (25%) of Subjects to Have AECB Recurrence [ Time Frame: Number of Days ]
  • Change From Baseline in Clinical COPD Questionnaire(CCQ)Total Score [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ]
  • Change From Baseline in Clinical COPD Questionnaire(CCQ)Symptoms Score [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ]
  • Change From Baseline in Clinical COPD Questionnaire(CCQ)Functional State Score [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ]
  • Change From Baseline in Clinical COPD Questionnaire(CCQ)Mental State Score [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ]
Original Secondary Outcome Measures  ICMJE
 (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  ICMJE A Trial To Evaluate Two Antibiotics For The Treatment Of Acute Exacerbation Of Chronic Bronchitis (AECB)
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Bronchitis
Intervention  ICMJE
  • 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  ICMJE
  • Experimental: 1
    Interventions:
    • Other: Azithromycin SR Placebo
    • Drug: Azithromycin SR
  • Active Comparator: 2
    Interventions:
    • Other: Moxifloxacin Placebo
    • Drug: Moxifloxacin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 8, 2008)
398
Original Enrollment  ICMJE
 (submitted: November 14, 2005)
416
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   Malaysia,   Philippines,   Singapore,   Taiwan,   Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00254566
Other Study ID Numbers  ICMJE A0661147
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP