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

NCT00644449 | Completed Phase 3

• 1 other identifier: A0661102
• Study Type: interventional
• Target: 551
• Locations: 13 countries
• Sites: 75

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

Conditions

Bronchitis, Chronic

Outcome Measures

Primary Outcomes (1)

• sponsor assessment of clinical response in the Clinical Per Protocol population

  Test of Cure (TOC) visit (Day 14-21)

Secondary Outcomes (9)

• investigator assessment of clinical response in the Clinical Per Protocol population

  TOC visit

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

  TOC visit

• sponsor assessment of clinical response in the Clinical Per Protocol population

  Long-Term Follow-Up (LTFU) visit (Day 28-35)

• Summary of baseline susceptibilities

  Study Endpoint

• adverse events

  Continuous

Study Arms (2)

1

EXPERIMENTAL

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

2

EXPERIMENTAL

Other: placebo; Drug: levofloxacin

Interventions

placebo OTHER

placebo

1

azithromycin SR (Zithromax; compound: CP-62,993) DRUG

azithromycin 2.0 g by mouth in the form of a slurry for 1 dose

1

levofloxacin DRUG

500 mg (two 250 mg capsules) by mouth once daily for 7 days

2

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (75)

Pfizer Investigational Site

Birmingham, Alabama, 35215, United States

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Birmingham, Alabama, 35233, United States

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Columbiana, Alabama, 35051, United States

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Tallassee, Alabama, 36078, United States

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Mesa, Arizona, 85201, United States

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Phoenix, Arizona, 85014, United States

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Tempe, Arizona, 85282, United States

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Daytona Beach, Florida, 32114, United States

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Merritt Island, Florida, 32953, United States

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Austell, Georgia, 30106, United States

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Evansville, Indiana, 47712, United States

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Madisonville, Kentucky, 42431, United States

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New Orleans, Louisiana, 70115, United States

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Kalamazoo, Michigan, 49009, United States

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Royal Oak, Michigan, 48073, United States

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Olive Branch, Mississippi, 38654, United States

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Elkhorn, Nebraska, 68022, United States

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Omaha, Nebraska, 68105, United States

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Omaha, Nebraska, 68144, United States

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Columbus, Ohio, 43214, United States

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Columbus, Ohio, 43215, United States

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Columbus, Ohio, 43222, United States

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Allentown, Pennsylvania, 18102, United States

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Harrisburg, Pennsylvania, 17011, United States

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Harrisburg, Pennsylvania, 17110, United States

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Morrisville, Pennsylvania, 19067, United States

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Willow Grove, Pennsylvania, 19090, United States

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Milan, Tennessee, 38358, United States

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San Antonio, Texas, 78224, United States

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Curitiba, Paraná, 80060-900, Brazil

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Porto Alegre, Rio Grande do Sul, 90035-002, Brazil

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Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

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Porto Alegre, Rio Grande do Sul, 90035-074, Brazil

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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

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Santo André, São Paulo, 09060-650, Brazil

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Edmonton, Alberta, T5A 4L8, Canada

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Edmonton, Alberta, T5N 2N8, Canada

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Sydney, Nova Scotia, B1S 1A9, Canada

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Hawkesbury, Ontario, K6A 1A1, Canada

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Toronto, Ontario, M9W 4L6, Canada

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Ste-Foy, Quebec, G1V 4G5, Canada

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North Battleford, Saskatchewan, S9A 0V6, Canada

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Saskatoon, Saskatchewan, S7K 3H3, Canada

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Desamparados, Provincia de San José, Costa Rica

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Guadalupe, Provincia de San José, Costa Rica

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Pavas, Provincia de San José, Costa Rica

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Pinares de Curridabat, Provincia de San José, Costa Rica

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San José, Provincia de San José, Costa Rica

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Uruca, Provincia de San José, Costa Rica

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Berlin, 10965, Germany

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Rathenow, 14712, Germany

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Bangalore, Karnataka, 560 034, India

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Elamakkara, Cochin, Kerala, 682 026, India

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Indore, Madhya Pradesh, 452 001, India

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Pune, Maharashtra, 411 053, India

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Ludhiana, Punjab, 141 001, India

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Coimbatore, Tamil Nadu, 641022, India

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Alytus, LT-4580, Lithuania

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Klaipėda, LT-5800, Lithuania

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Vilnius, LT-2010, Lithuania

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Monterrey, Nuevo León, 64460, Mexico

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Eindhoven, 5623 EJ, Netherlands

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Moscow, 105077, Russia

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Moscow, 105229, Russia

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Moscow, 107066, Russia

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Moscow, 119048, Russia

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Moscow, Russia

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Smolensk, 214019, Russia

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Madrid, 28006, Spain

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Madrid, 28007, Spain

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Málaga, 29010, Spain

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Atherstone, Warwickshire, CV9 1EU, United Kingdom

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Leeds, West Yorkshire, LS12 1JE, United Kingdom

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Glasgow, G45 9AW, United Kingdom

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Caracas, Venezuela

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Related Links

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

MeSH Terms

Conditions

Bronchitis, Chronic

Interventions

Azithromycin; Levofloxacin

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 19, 2008
• First Posted: March 26, 2008
• Study Start: January 1, 2003
• Study Completion: March 1, 2004
• Last Updated: May 16, 2011

Record last verified: 2011-05

Locations

ME (1); NL (1); RU (6); ES (3); CO (6); BR (6); GB (3); LI (3); IN (6); US (29); VE (1); CA (8); DE (2)