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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00644449
First Posted: March 26, 2008
Last Update Posted: May 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
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

Condition Intervention Phase
Bronchitis, Chronic Other: placebo Drug: azithromycin SR (Zithromax; compound: CP-62,993) Drug: levofloxacin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Levofloxacin for the Treatment of Acute Exacerbation of Chronic Bronchitis (AECB)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • sponsor assessment of clinical response in the Clinical Per Protocol population [ Time Frame: Test of Cure (TOC) visit (Day 14-21) ]

Secondary Outcome Measures:
  • investigator assessment of clinical response in the Clinical Per Protocol population [ Time Frame: TOC visit ]
  • bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population [ Time Frame: TOC visit ]
  • sponsor assessment of clinical response in the Clinical Per Protocol population [ Time Frame: Long-Term Follow-Up (LTFU) visit (Day 28-35) ]
  • Summary of baseline susceptibilities [ Time Frame: Study Endpoint ]
  • adverse events [ Time Frame: Continuous ]
  • clinical laboratory tests [ Time Frame: Baseline and EOT visit ]
  • sponsor assessment of clinical response in the Clinical Per Protocol population [ Time Frame: End of Treatment (EOT) visit (Day 8-11) ]
  • sponsor assessment of clinical response in the remaining study populations [ Time Frame: TOC visit ]
  • sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population [ Time Frame: EOT visit and TOC visit ]

Enrollment: 551
Study Start Date: January 2003
Study Completion Date: March 2004
Arms Assigned Interventions
Experimental: 1 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
Experimental: 2 Other: placebo
placebo
Drug: levofloxacin
500 mg (two 250 mg capsules) by mouth once daily for 7 days

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644449


  Show 75 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00644449     History of Changes
Other Study ID Numbers: A0661102
First Submitted: March 19, 2008
First Posted: March 26, 2008
Last Update Posted: May 16, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Bronchitis
Acute Disease
Bronchitis, Chronic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Levofloxacin
Ofloxacin
Azithromycin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors


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