Clinical trial NCT00644449: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bronchitis, Chronic
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 551
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility 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).

Primary outcomes:
measure: sponsor assessment of clinical response in the Clinical Per Protocol population
timeFrame: Test of Cure (TOC) visit (Day 14-21)
Secondary outcomes:
measure: investigator assessment of clinical response in the Clinical Per Protocol population
timeFrame: TOC visit
measure: bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population
timeFrame: TOC visit
measure: sponsor assessment of clinical response in the Clinical Per Protocol population
timeFrame: Long-Term Follow-Up (LTFU) visit (Day 28-35)
measure: Summary of baseline susceptibilities
timeFrame: Study Endpoint
measure: adverse events
timeFrame: Continuous
measure: clinical laboratory tests
timeFrame: Baseline and EOT visit
measure: sponsor assessment of clinical response in the Clinical Per Protocol population
timeFrame: End of Treatment (EOT) visit (Day 8-11)
measure: sponsor assessment of clinical response in the remaining study populations
timeFrame: TOC visit
measure: sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population
timeFrame: EOT visit and TOC visit
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Columbiana
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Tallassee
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Mesa
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tempe
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Daytona Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Merritt Island
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Austell
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Evansville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Madisonville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Kalamazoo
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Royal Oak
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Olive Branch
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Elkhorn
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Allentown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Harrisburg
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Harrisburg
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Morrisville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Willow Grove
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Milan
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Curitiba
country: Brazil
facility: Pfizer Investigational Site
state: PR
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: Santo André
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Sydney
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Hawkesbury
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Ste-Foy
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: North Battleford
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Desamparados
country: Costa Rica
facility: Pfizer Investigational Site
state: San Jose
city: Guadalupe
country: Costa Rica
facility: Pfizer Investigational Site
state: San Jose
city: La Uruca
country: Costa Rica
facility: Pfizer Investigational Site
state: San Jose
city: Pavas
country: Costa Rica
facility: Pfizer Investigational Site
state: San Jose
city: Pinares de Curridabat
country: Costa Rica
facility: Pfizer Investigational Site
state: San Jose
city: San Jose
country: Costa Rica
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Rathenow
country: Germany
facility: Pfizer Investigational Site
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Elamakkara, Cochin
country: India
facility: Pfizer Investigational Site
state: Kerala
city: Indore
country: India
facility: Pfizer Investigational Site
state: Madhya Pradesh
city: Pune
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Ludhiana
country: India
facility: Pfizer Investigational Site
state: Punjab
city: Coimbatore
country: India
facility: Pfizer Investigational Site
state: Tamil Nadu
city: Alytus
country: Lithuania
facility: Pfizer Investigational Site
city: Klaipeda
country: Lithuania
facility: Pfizer Investigational Site
city: Vilnius
country: Lithuania
facility: Pfizer Investigational Site
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo Leon
city: Eindhoven
country: Netherlands
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Smolensk
country: Russian Federation
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Málaga
country: Spain
facility: Pfizer Investigational Site
city: Atherstone
country: United Kingdom
facility: Pfizer Investigational Site
state: Warwickshire
city: Leeds
country: United Kingdom
facility: Pfizer Investigational Site
state: West Yorkshire
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
city: Caracas
country: Venezuela
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: