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: “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

Intervention(s) in this Clinical Trial

• 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
• Other: placebo
  • placebo
• Drug: levofloxacin
  • 500 mg (two 250 mg capsules) by mouth once daily for 7 days

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2

Primary Measures

• sponsor assessment of clinical response in the Clinical Per Protocol population
  • Time Frame: Test of Cure (TOC) visit (Day 14-21)
    Safety Issue?: No

Secondary Measures

• investigator assessment of clinical response in the Clinical Per Protocol population
  • Time Frame: TOC visit
    Safety Issue?: No
• bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population
  • Time Frame: TOC visit
    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)
    Safety Issue?: No
• Summary of baseline susceptibilities
  • Time Frame: Study Endpoint
    Safety Issue?: No
• adverse events
  • Time Frame: Continuous
    Safety Issue?: Yes
• clinical laboratory tests
  • Time Frame: Baseline and EOT visit
    Safety Issue?: Yes
• sponsor assessment of clinical response in the Clinical Per Protocol population
  • Time Frame: End of Treatment (EOT) visit (Day 8-11)
    Safety Issue?: No
• sponsor assessment of clinical response in the remaining study populations
  • Time Frame: TOC visit
    Safety Issue?: No
• sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population
  • Time Frame: EOT visit and TOC visit
    Safety Issue?: No

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).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 35 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00644449

Study ID Number: A0661102

ClinicalTrials.gov Identifier: NCT00644449

Health Authority: United States: Food and Drug Administration

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