A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Acute Symptoms of Chronic Bronchitis - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00644449

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 III

MedlinePlus related topics: Bronchitis

Drug Information available for: Azithromycin Levofloxacin Ofloxacin Ofloxacin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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)

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:	530
Study Start Date:	January 2003
Study Completion Date:	March 2004

Arms	Assigned Interventions
1: Experimental	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
2: Experimental	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 76 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

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

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0661102
Study First Received:	March 19, 2008
Last Updated:	March 19, 2008
ClinicalTrials.gov Identifier:	NCT00644449
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Acute Disease
Bronchitis, Chronic
Lung Diseases, Obstructive
Respiratory Tract Infections
Respiratory Tract Diseases

Azithromycin
Lung Diseases
Ofloxacin
Bronchitis
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Disease Attributes
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Bronchial Diseases

Therapeutic Uses
Anti-Infective Agents, Urinary
Enzyme Inhibitors
Renal Agents
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009