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

NCT00254566

Last updated date
Study Location
Pfizer Investigational Site
Guangzhou, Guangdong, 510080, China
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Bronchitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Chronic BronchitisA Trial To Evaluate Two Antibiotics For The Treatment Of Acute Exacerbation Of Chronic Bronchitis (AECB)
NCT00254566
  1. Guangzhou, Guangdong
  2. Shijiazhuang, Hebei
  3. Nanjing, Jiangsu
  4. Shenyang, Liaoning
  5. Xi'an, Shanxi
  6. Xi'an, Shanxi
  7. Hangzhou, Zhejiang
  8. Beijing,
  9. Beijing,
  10. Chongqing,
  11. Chongqing,
  12. Hangzhou,
  13. Shanghai,
  14. Shanghai,
  15. Shanghai,
  16. Cheras, Kuala Lumpur
  17. Lembah Pantai, Kuala Lumpur
  18. Manila,
  19. Manila,
  20. Quezon City,
  21. Quezon City,
  22. Singapore,
  23. Singapore,
  24. NeiHu, Taipei
  25. Kuei Shan Hsiang, Taoyuan Hsien
  26. Taichung,
  27. Taichung,
  28. Taipei,
  29. Vachira Dusit, Bangkok
  30. Maerim, Chiangmai
  31. Bangkok,
  32. Bangkok,
  33. Chiang Mai,
  34. Khon Kaen,
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Advanced Information
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 CenterPfizer
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