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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 May 11, 2018

FOR MORE INFORMATION
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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A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Acute Symptoms of Chronic Bronchitis
A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Levofloxacin for the Treatment of Acute Exacerbation of Chronic Bronchitis (AECB)
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Bronchitis, Chronic
  • 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
  • Experimental: 1
    Interventions:
    • Other: placebo
    • Drug: azithromycin SR (Zithromax; compound: CP-62,993)
  • Experimental: 2
    Interventions:
    • Other: placebo
    • Drug: levofloxacin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
551
March 2004
Not Provided

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).

Sexes Eligible for Study: All
35 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Canada,   Costa Rica,   Germany,   India,   Lithuania,   Mexico,   Netherlands,   Russian Federation,   Spain,   United Kingdom,   United States,   Venezuela
 
 
NCT00644449
A0661102
Not Provided
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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1-800-718-1021

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