A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Acute Symptoms of Chronic Bronchitis

NCT00644449

Last updated date
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35215, United States
Contact
1-800-718-1021

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

Adult patients with a history of chronic bronchitis (i.e., chronic cough and sputum production on most days for 3 consecutive months for more than 2 years) and current evidence of an acute bacterial exacerbation of their disease, as demonstrated by production of purulent sputum and the presence of at lest 2 of the following signs and symptoms, were included: increased sputum production, increased dypsnea, increased cough, or increased sputum purulence.

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


Key exclusion criteria were treatment with any systemic antibiotic within the previous 7
days, or the likelihood of receiving other systemic antibiotics during participation in the
study; a chest radiograph consistent with pneumonia; and previously diagnosed conditions
which tend to mimic or complicate the course and evaluation of the infectious process
(e.g., bronchiectasis, lung abscess or empyema, active TB, pulmonary malignancy, cystic
fibrosis).

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Bronchitis, ChronicA Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Acute Symptoms of Chronic Bronchitis
NCT00644449
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Columbiana, Alabama
  4. Tallassee, Alabama
  5. Mesa, Arizona
  6. Phoenix, Arizona
  7. Tempe, Arizona
  8. Daytona Beach, Florida
  9. Merritt Island, Florida
  10. Austell, Georgia
  11. Evansville, Indiana
  12. Madisonville, Kentucky
  13. New Orleans, Louisiana
  14. Kalamazoo, Michigan
  15. Royal Oak, Michigan
  16. Olive Branch, Mississippi
  17. Elkhorn, Nebraska
  18. Omaha, Nebraska
  19. Omaha, Nebraska
  20. Columbus, Ohio
  21. Columbus, Ohio
  22. Columbus, Ohio
  23. Allentown, Pennsylvania
  24. Harrisburg, Pennsylvania
  25. Harrisburg, Pennsylvania
  26. Morrisville, Pennsylvania
  27. Willow Grove, Pennsylvania
  28. Milan, Tennessee
  29. San Antonio, Texas
  30. Curitiba, PR
  31. Porto Alegre, RS
  32. Porto Alegre, RS
  33. Porto Alegre, RS
  34. Porto Alegre, RS
  35. Santo André, SP
  36. Edmonton, Alberta
  37. Edmonton, Alberta
  38. Sydney, Nova Scotia
  39. Hawkesbury, Ontario
  40. Toronto, Ontario
  41. Ste-Foy, Quebec
  42. North Battleford, Saskatchewan
  43. Saskatoon, Saskatchewan
  44. Desamparados, San Jose
  45. Guadalupe, San Jose
  46. La Uruca, San Jose
  47. Pavas, San Jose
  48. Pinares de Curridabat, San Jose
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  51. Rathenow,
  52. Bangalore, Karnataka
  53. Elamakkara, Cochin, Kerala
  54. Indore, Madhya Pradesh
  55. Pune, Maharashtra
  56. Ludhiana, Punjab
  57. Coimbatore, Tamil Nadu
  58. Alytus,
  59. Klaipeda,
  60. Vilnius,
  61. Monterrey, Nuevo Leon
  62. Eindhoven,
  63. Moscow,
  64. Moscow,
  65. Moscow,
  66. Moscow,
  67. Moscow,
  68. Smolensk,
  69. Madrid,
  70. Madrid,
  71. Málaga,
  72. Atherstone, Warwickshire
  73. Leeds, West Yorkshire
  74. Glasgow,
  75. Caracas,
ALL GENDERS
35 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Acute Symptoms of Chronic Bronchitis
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Levofloxacin for the Treatment of Acute Exacerbation of Chronic Bronchitis (AECB)
Brief Summary This study was performed to confirm that a single 2.0-g dose of azithromycin SR is at least as effective as 7 days of levofloxacin 500 mg/day in adults with acute exacerbation of chronic bronchitis Secondary objectives: To assess safety and the bacteriologic efficacy of both treatment regimens
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 Bronchitis, Chronic
Intervention  ICMJE
  • Other: placebo
    placebo
  • Drug: azithromycin SR (Zithromax; compound: CP-62,993)
    azithromycin 2.0 g by mouth in the form of a slurry for 1 dose
  • Drug: levofloxacin
    500 mg (two 250 mg capsules) by mouth once daily for 7 days
Study Arms  ICMJE
  • Experimental: 1
    Interventions:
    • Other: placebo
    • Drug: azithromycin SR (Zithromax; compound: CP-62,993)
  • Experimental: 2
    Interventions:
    • Other: placebo
    • Drug: levofloxacin
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: May 12, 2011)
551
Original Actual Enrollment  ICMJE
 (submitted: March 19, 2008)
530
Actual Study Completion Date  ICMJE March 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

Adult patients with a history of chronic bronchitis (i.e., chronic cough and sputum production on most days for 3 consecutive months for more than 2 years) and current evidence of an acute bacterial exacerbation of their disease, as demonstrated by production of purulent sputum and the presence of at lest 2 of the following signs and symptoms, were included: increased sputum production, increased dypsnea, increased cough, or increased sputum purulence.

Exclusion Criteria:

Key exclusion criteria were treatment with any systemic antibiotic within the previous 7 days, or the likelihood of receiving other systemic antibiotics during participation in the study; a chest radiograph consistent with pneumonia; and previously diagnosed conditions which tend to mimic or complicate the course and evaluation of the infectious process (e.g., bronchiectasis, lung abscess or empyema, active TB, pulmonary malignancy, cystic fibrosis).

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 35 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 Brazil,   Canada,   Costa Rica,   Germany,   India,   Lithuania,   Mexico,   Netherlands,   Russian Federation,   Spain,   United Kingdom,   United States,   Venezuela
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00644449
Other Study ID Numbers  ICMJE A0661102
Has Data Monitoring Committee Not Provided
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 May 2011

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