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

Last updated on November 21, 2019

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35215 United States
Contact
1-800-718-1021
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
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).

NCT00644449
Pfizer
Completed
A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Acute Symptoms of Chronic Bronchitis

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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 SummaryThis 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 DescriptionNot 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 DateNot 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 CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMay 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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