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NCT00644449 Clinical Trial

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

Bronchitis, Chronic Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00644449
Other study ID # A0661102
Secondary ID
Status Completed
Phase Phase 3
First received March 19, 2008
Last updated May 12, 2011
Start date January 2003
Est. completion date March 2004

Study information
Verified date May 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 551
Est. completion date March 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 35 Years and older
Eligibility 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).

Study Design

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

Related Conditions & MeSH terms

Intervention

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
Other:
• placebo
placebo
Drug:
• levofloxacin
500 mg (two 250 mg capsules) by mouth once daily for 7 days

Locations
Country Name City State
Brazil Pfizer Investigational Site Curitiba PR
Brazil Pfizer Investigational Site Porto Alegre RS
Brazil Pfizer Investigational Site Porto Alegre RS
Brazil Pfizer Investigational Site Porto Alegre RS
Brazil Pfizer Investigational Site Porto Alegre RS
Brazil Pfizer Investigational Site Santo André SP
Canada Pfizer Investigational Site Edmonton Alberta
Canada Pfizer Investigational Site Edmonton Alberta
Canada Pfizer Investigational Site Hawkesbury Ontario
Canada Pfizer Investigational Site North Battleford Saskatchewan
Canada Pfizer Investigational Site Saskatoon Saskatchewan
Canada Pfizer Investigational Site Ste-Foy Quebec
Canada Pfizer Investigational Site Sydney Nova Scotia
Canada Pfizer Investigational Site Toronto Ontario
Costa Rica 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 San Jose
Germany Pfizer Investigational Site Berlin
Germany Pfizer Investigational Site Rathenow
India Pfizer Investigational Site Bangalore Karnataka
India Pfizer Investigational Site Coimbatore Tamil Nadu
India Pfizer Investigational Site Elamakkara, Cochin Kerala
India Pfizer Investigational Site Indore Madhya Pradesh
India Pfizer Investigational Site Ludhiana Punjab
India Pfizer Investigational Site Pune Maharashtra
Lithuania Pfizer Investigational Site Alytus
Lithuania Pfizer Investigational Site Klaipeda
Lithuania Pfizer Investigational Site Vilnius
Mexico Pfizer Investigational Site Monterrey Nuevo Leon
Netherlands Pfizer Investigational Site Eindhoven
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Smolensk
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Málaga
United Kingdom Pfizer Investigational Site Atherstone Warwickshire
United Kingdom Pfizer Investigational Site Glasgow
United Kingdom Pfizer Investigational Site Leeds West Yorkshire
United States Pfizer Investigational Site Allentown Pennsylvania
United States Pfizer Investigational Site Austell Georgia
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Columbiana Alabama
United States Pfizer Investigational Site Columbus Ohio
United States Pfizer Investigational Site Columbus Ohio
United States Pfizer Investigational Site Columbus Ohio
United States Pfizer Investigational Site Daytona Beach Florida
United States Pfizer Investigational Site Elkhorn Nebraska
United States Pfizer Investigational Site Evansville Indiana
United States Pfizer Investigational Site Harrisburg Pennsylvania
United States Pfizer Investigational Site Harrisburg Pennsylvania
United States Pfizer Investigational Site Kalamazoo Michigan
United States Pfizer Investigational Site Madisonville Kentucky
United States Pfizer Investigational Site Merritt Island Florida
United States Pfizer Investigational Site Mesa Arizona
United States Pfizer Investigational Site Milan Tennessee
United States Pfizer Investigational Site Morrisville Pennsylvania
United States Pfizer Investigational Site New Orleans Louisiana
United States Pfizer Investigational Site Olive Branch Mississippi
United States Pfizer Investigational Site Omaha Nebraska
United States Pfizer Investigational Site Omaha Nebraska
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Royal Oak Michigan
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site Tallassee Alabama
United States Pfizer Investigational Site Tempe Arizona
United States Pfizer Investigational Site Willow Grove Pennsylvania
Venezuela Pfizer Investigational Site Caracas

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Venezuela,  Brazil,  Canada,  Costa Rica,  Germany,  India,  Lithuania,  Mexico,  Netherlands,  Russian Federation,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary sponsor assessment of clinical response in the Clinical Per Protocol population Test of Cure (TOC) visit (Day 14-21) No
Secondary investigator assessment of clinical response in the Clinical Per Protocol population TOC visit No
Secondary bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population TOC visit No
Secondary sponsor assessment of clinical response in the Clinical Per Protocol population Long-Term Follow-Up (LTFU) visit (Day 28-35) No
Secondary Summary of baseline susceptibilities Study Endpoint No
Secondary adverse events Continuous Yes
Secondary clinical laboratory tests Baseline and EOT visit Yes
Secondary sponsor assessment of clinical response in the Clinical Per Protocol population End of Treatment (EOT) visit (Day 8-11) No
Secondary sponsor assessment of clinical response in the remaining study populations TOC visit No
Secondary sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population EOT visit and TOC visit No
See also
  Status Clinical Trial Phase
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Completed NCT00649831 - A Multicentre, Randomised, Open-Label Study To Compare The Efficacy And Safety Of Azithromycin For 5 Days With Those Of Amoxicillin-Clavulanic Acid In Patients With Chronic Bronchitis Phase 3
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Completed NCT00538148 - Telithromycin: in the Treatment of Acute Exacerbation of Chronic Bronchitis in Adult Outpatients With COPD Phase 4
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Completed NCT00257140 - A Study of the Safety and Effectiveness of Levofloxacin Compared With Cefaclor in the Treatment of Adults With Chronic Bronchitis Experiencing Rapid Onset of Worsening of Symptoms Caused by Bacteria Phase 2/Phase 3
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Completed NCT01077102 - Eccentric Exercise Training as Novel Rehabilitation for Chronic Obstructive Pulmonary Disease (COPD) N/A
Terminated NCT00288223 - Telithromycin in Acute Exacerbation of Chronic Bronchitis Phase 4
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Completed NCT00035828 - A Blinded Study Comparing the Safety and Efficacy of a Fully Human Anti-IL8 Monoclonal Antibody (ABX-IL8) to Placebo in Patients With Chronic Bronchitis and COPD Phase 2
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