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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:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00644449
First received: March 19, 2008
Last updated: May 12, 2011
Last verified: May 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • investigator assessment of clinical response in the Clinical Per Protocol population [ Time Frame: TOC visit ] [ Designated as safety issue: No ]
  • bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population [ Time Frame: TOC visit ] [ Designated as safety issue: No ]
  • sponsor assessment of clinical response in the Clinical Per Protocol population [ Time Frame: Long-Term Follow-Up (LTFU) visit (Day 28-35) ] [ Designated as safety issue: No ]
  • Summary of baseline susceptibilities [ Time Frame: Study Endpoint ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]
  • clinical laboratory tests [ Time Frame: Baseline and EOT visit ] [ Designated as safety issue: Yes ]
  • sponsor assessment of clinical response in the Clinical Per Protocol population [ Time Frame: End of Treatment (EOT) visit (Day 8-11) ] [ Designated as safety issue: No ]
  • sponsor assessment of clinical response in the remaining study populations [ Time Frame: TOC visit ] [ Designated as safety issue: No ]
  • sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population [ Time Frame: EOT visit and TOC visit ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644449

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

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00644449     History of Changes
Other Study ID Numbers: A0661102
Study First Received: March 19, 2008
Last Updated: May 12, 2011
Health Authority: United States: Food and Drug Administration

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
 Ofloxacin
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on May 21, 2013