A Phase 3 interventional study of placebo and azithromycin SR (Zithromax; compound: CP-62,993) in Bronchitis, Chronic, sponsored by Pfizer. Completed at 75 sites in 13 countries. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2011-05-16.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
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
268 studies on the registry are indexed under Bronchitis; 26 are open to participants now.
This study's enrollment of 551 is above the median of 120 across 184 interventional studies indexed under Bronchitis.
Browse Bronchitis studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
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).
Other: placebo · Drug: azithromycin SR (Zithromax; compound: CP-62,993)
Other: placebo · Drug: levofloxacin
placebo
azithromycin 2.0 g by mouth in the form of a slurry for 1 dose
placebo
500 mg (two 250 mg capsules) by mouth once daily for 7 days
sponsor assessment of clinical response in the Clinical Per Protocol population
Time frame: Test of Cure (TOC) visit (Day 14-21)
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
This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.
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