DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bronchitis, Chronic

Intervention: placebo (Other); azithromycin SR (Zithromax; compound: CP-62,993) (Drug); placebo (Other); levofloxacin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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

Clinical Details

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)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: sponsor assessment of clinical response in the Clinical Per Protocol population

Secondary outcome:

investigator assessment of clinical response in the Clinical Per Protocol population

bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population

sponsor assessment of clinical response in the Clinical Per Protocol population

Summary of baseline susceptibilities

adverse events

clinical laboratory tests

sponsor assessment of clinical response in the Clinical Per Protocol population

sponsor assessment of clinical response in the remaining study populations

sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population

Eligibility

Minimum age: 35 Years. Maximum age: N/A. Gender(s): Both.

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).

Locations and Contacts

Pfizer Investigational Site, San Jose, Costa Rica

Pfizer Investigational Site, Berlin 10965, Germany

Pfizer Investigational Site, Rathenow 14712, Germany

Pfizer Investigational Site, Alytus LT-4580, Lithuania

Pfizer Investigational Site, Klaipeda LT-5800, Lithuania

Pfizer Investigational Site, Vilnius LT-2010, Lithuania

Pfizer Investigational Site, Eindhoven 5623 EJ, Netherlands

Pfizer Investigational Site, Moscow, Russian Federation

Pfizer Investigational Site, Moscow 105229, Russian Federation

Pfizer Investigational Site, Moscow 107066, Russian Federation

Pfizer Investigational Site, Moscow 119048, Russian Federation

Pfizer Investigational Site, Moscow 105077, Russian Federation

Pfizer Investigational Site, Smolensk 214019, Russian Federation

Pfizer Investigational Site, Madrid 28006, Spain

Pfizer Investigational Site, Madrid 28007, Spain

Pfizer Investigational Site, Málaga 29010, Spain

Pfizer Investigational Site, Glasgow G45 9AW, United Kingdom

Pfizer Investigational Site, Caracas, Venezuela

Pfizer Investigational Site, Birmingham, Alabama 35215, United States

Pfizer Investigational Site, Birmingham, Alabama 35233, United States

Pfizer Investigational Site, Columbiana, Alabama 35051, United States

Pfizer Investigational Site, Tallassee, Alabama 36078, United States

Pfizer Investigational Site, Edmonton, Alberta T5A 4L8, Canada

Pfizer Investigational Site, Edmonton, Alberta T5N 2N8, Canada

Pfizer Investigational Site, Mesa, Arizona 85201, United States

Pfizer Investigational Site, Phoenix, Arizona 85014, United States

Pfizer Investigational Site, Tempe, Arizona 85282, United States

Pfizer Investigational Site, Daytona Beach, Florida 32114, United States

Pfizer Investigational Site, Merritt Island, Florida 32953, United States

Pfizer Investigational Site, Austell, Georgia 30106, United States

Pfizer Investigational Site, Evansville, Indiana 47712, United States

Pfizer Investigational Site, Bangalore, Karnataka 560 034, India

Pfizer Investigational Site, Madisonville, Kentucky 42431, United States

Pfizer Investigational Site, Elamakkara, Cochin, Kerala 682 026, India

Pfizer Investigational Site, New Orleans, Louisiana 70115, United States

Pfizer Investigational Site, Indore, Madhya Pradesh 452 001, India

Pfizer Investigational Site, Pune, Maharashtra 411 053, India

Pfizer Investigational Site, Kalamazoo, Michigan 49009, United States

Pfizer Investigational Site, Royal Oak, Michigan 48073, United States

Pfizer Investigational Site, Olive Branch, Mississippi 38654, United States

Pfizer Investigational Site, Elkhorn, Nebraska 68022, United States

Pfizer Investigational Site, Omaha, Nebraska 68105, United States

Pfizer Investigational Site, Omaha, Nebraska 68144, United States

Pfizer Investigational Site, Sydney, Nova Scotia B1S 1A9, Canada

Pfizer Investigational Site, Monterrey, Nuevo Leon 64460, Mexico

Pfizer Investigational Site, Columbus, Ohio 43214, United States

Pfizer Investigational Site, Columbus, Ohio 43215, United States

Pfizer Investigational Site, Columbus, Ohio 43222, United States

Pfizer Investigational Site, Hawkesbury, Ontario K6A 1A1, Canada

Pfizer Investigational Site, Toronto, Ontario M9W 4L6, Canada

Pfizer Investigational Site, Curitiba, PR 80060-900, Brazil

Pfizer Investigational Site, Allentown, Pennsylvania 18102, United States

Pfizer Investigational Site, Harrisburg, Pennsylvania 17011, United States

Pfizer Investigational Site, Harrisburg, Pennsylvania 17110, United States

Pfizer Investigational Site, Morrisville, Pennsylvania 19067, United States

Pfizer Investigational Site, Willow Grove, Pennsylvania 19090, United States

Pfizer Investigational Site, Ludhiana, Punjab 141 001, India

Pfizer Investigational Site, Ste-Foy, Quebec G1V 4G5, Canada

Pfizer Investigational Site, Porto Alegre, RS 90035-003, Brazil

Pfizer Investigational Site, Porto Alegre, RS 90035-002, Brazil

Pfizer Investigational Site, Porto Alegre, RS 90035-074, Brazil

Pfizer Investigational Site, Porto Alegre, RS 90610-000, Brazil

Pfizer Investigational Site, Santo André, SP 09060-650, Brazil

Pfizer Investigational Site, Desamparados, San Jose, Costa Rica

Pfizer Investigational Site, Guadalupe, San Jose, Costa Rica

Pfizer Investigational Site, La Uruca, San Jose, Costa Rica

Pfizer Investigational Site, Pavas, San Jose, Costa Rica

Pfizer Investigational Site, Pinares de Curridabat, San Jose, Costa Rica

Pfizer Investigational Site, North Battleford, Saskatchewan S9A 0V6, Canada

Pfizer Investigational Site, Saskatoon, Saskatchewan S7K 3H3, Canada

Pfizer Investigational Site, Coimbatore, Tamil Nadu 641022, India

Pfizer Investigational Site, Milan, Tennessee 38358, United States

Pfizer Investigational Site, San Antonio, Texas 78224, United States

Pfizer Investigational Site, Atherstone, Warwickshire CV9 1EU, United Kingdom

Pfizer Investigational Site, Leeds, West Yorkshire LS12 1JE, United Kingdom

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: January 2003
Last updated: May 12, 2011

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017