Placebo
Otherplacebo
NCT Number: NCT00644449
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
Looking for future studies?
Notify Me35 year and older
All sexes
Interventional
Phase 3
Pfizer Investigational Site, Curitiba, Paraná, Brazil
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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).
placebo
azithromycin 2.0 g by mouth in the form of a slurry for 1 dose
500 mg (two 250 mg capsules) by mouth once daily for 7 days
Time frame: Test of Cure (TOC) visit (Day 14-21)
Time frame: TOC visit
Time frame: TOC visit
Time frame: Long-Term Follow-Up (LTFU) visit (Day 28-35)
Time frame: Study Endpoint
Time frame: Continuous
Time frame: Baseline and EOT visit
Time frame: End of Treatment (EOT) visit (Day 8-11)
Time frame: TOC visit
Time frame: EOT visit and TOC visit
Pfizer
Industry
A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Levofloxacin for the Treatment of Acute Exacerbation of Chronic Bronchitis (AECB)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00871637
Bronchial Diseases, Bronchitis
Omaha, Nebraska, United States
View Trial DetailsNCT02483637
Bronchial Diseases, Bronchitis
Vancouver, British Columbia, Canada
View Trial DetailsNCT00423137
Bronchial Diseases, Bronchitis
Birmingham, Alabama, United States
View Trial DetailsNCT01495780
Behavior, Bronchial Diseases
Los Angeles, California, United States
View Trial Details