Comparative Study of 5 Days of M02-472 Clarithromycin Extended-Release Tablets to 7 Days of Clarithromycin Immediate-Release Tablets for the Treatment of Exacerbation of Chronic Bronchitis

A Phase III Comparative Efficacy Study of 5 Days of M02-472 Clarithromycin Extended-Release Tablets to 7 Days of Clarithromycin Immediate-Release Tablets for the Treatment of Subjects With Acute Bacterial Exacerbation of Chronic Bronchitis.

To compare the efficacy of a 5-day course of clarithromycin extended-release tablets (2 x 500 mg QD) with that of a 7-day course of clarithromycin immediate-release tablets (1 x 500 mg BID) in the treatment of acute bacterial exacerbation of chronic bronchitis.

Study Overview

• Status: Completed
• Conditions: Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB).
• Intervention / Treatment: Drug: clarithromycin extended-release tablets; Drug: clarithromycin immediate-release tablets

• Study Type: Interventional
• Enrollment (Actual): 465
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Coquitlam, British Columbia, Canada, V3K 3P4
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3R 0C5
  • Ontario
    • Kitchener, Ontario, Canada, N2C 2N9
    • Markham, Ontario, Canada, L6B 1A1
    • Mississauga, Ontario, Canada, L5M 2V8
    • Scarborough, Ontario, Canada, M1B 4Z8
    • Toronto, Ontario, Canada, M9W 4L6
  • Quebec
    • Sherbrooke, Quebec, Canada, J1J 2B8
    • Ste-Foy, Quebec, Canada, G1V 4G5
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7H 5M3
• Puerto Rico
  • San Juan, Puerto Rico, 00921-3201
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35242
    • Birmingham, Alabama, United States, 35235
    • Columbiana, Alabama, United States, 35051
    • Hoover, Alabama, United States, 35216
    • Mobile, Alabama, United States, 36608
    • Montgomery, Alabama, United States, 36106
    • Ozark, Alabama, United States, 36360
  • Arizona
    • Glendale, Arizona, United States, 85306
    • Phoenix, Arizona, United States, 85006
    • Sun City West, Arizona, United States, 85375
    • Tucson, Arizona, United States, 85712
    • Tucson, Arizona, United States, 85746
  • Arkansas
    • Camden, Arkansas, United States, 71701
  • California
    • Clovis, California, United States, 93611
    • Corona, California, United States, 92879
    • Fountain View, California, United States, 92708
    • Fresno, California, United States, 93703
    • Huntington Beach, California, United States, 92647
    • Lakewood, California, United States, 90712
    • Pasadena, California, United States, 91105
    • Rancho Cucamonga, California, United States, 91730
    • Roseville, California, United States, 95661
    • San Diego, California, United States, 92103
    • San Diego, California, United States, 92123
    • San Diego, California, United States, 92117
    • San Jose, California, United States, 95128
    • Sylmar, California, United States, 91342
    • Temecula, California, United States, 92591
    • Torrance, California, United States, 90505
    • Upland, California, United States, 91786
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
    • Loveland, Colorado, United States, 80538
    • Wheat Ridge, Colorado, United States, 80033
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
  • Florida
    • Brandon, Florida, United States, 33511
    • Deland, Florida, United States, 32720
    • Fort Lauderdale, Florida, United States, 33316
    • Gainesville, Florida, United States, 32605
    • Largo, Florida, United States, 33770
    • Merritt Island, Florida, United States, 32953
    • Miami, Florida, United States, 33186
    • Miami, Florida, United States, 33157
    • New Port Richey, Florida, United States, 34652
    • Orlando, Florida, United States, 32806
    • Panama City, Florida, United States, 32405
    • Tallahassee, Florida, United States, 36078
    • Tampa, Florida, United States, 33614
  • Georgia
    • Atlanta, Georgia, United States, 30342
    • Blue Ridge, Georgia, United States, 30513
    • Fort Gordon, Georgia, United States, 30905
    • Marietta, Georgia, United States, 30060
    • Rome, Georgia, United States, 30165-1698
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
  • Illinois
    • Chicago, Illinois, United States, 60612
    • Hines, Illinois, United States, 60141
    • Orland Park, Illinois, United States, 60462
  • Indiana
    • Elkhart, Indiana, United States, 46514
    • Evansville, Indiana, United States, 47712
    • Indianapolis, Indiana, United States, 46254
  • Kansas
    • Wichita, Kansas, United States, 67207
  • Kentucky
    • Lexington, Kentucky, United States, 40508
    • Murray, Kentucky, United States, 42071
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70816
    • Metairie, Louisiana, United States, 70006
    • New Orleans, Louisiana, United States, 70128
    • Sunset, Louisiana, United States, 70584
  • Maine
    • Auburn, Maine, United States, 04210
  • Maryland
    • Chester, Maryland, United States, 21619
  • Michigan
    • Dewitt, Michigan, United States, 48820
    • Livonia, Michigan, United States, 48152
    • Saginaw, Michigan, United States, 48602
    • St. Joseph, Michigan, United States, 49085
  • Missouri
    • Chesterfield, Missouri, United States, 63017
    • Jefferson City, Missouri, United States, 65109
    • Springfield, Missouri, United States, 65802
    • St. Louis, Missouri, United States, 63110-1093
  • Montana
    • Missoula, Montana, United States, 59804
  • Nebraska
    • Omaha, Nebraska, United States, 68134
  • New Jersey
    • Blackwood, New Jersey, United States, 08012
    • Mount Laurel, New Jersey, United States, 08054
    • Toms River, New Jersey, United States, 08755
    • West Caldwell, New Jersey, United States, 07007
  • New York
    • Astoria, New York, United States, 11102
    • Bronxville, New York, United States, 10708
    • Buffalo, New York, United States, 14215
    • Camillus, New York, United States, 13031
    • New York, New York, United States, 10016
  • North Carolina
    • Greensboro, North Carolina, United States, 27401
    • Winston-Salem, North Carolina, United States, 27103
  • Ohio
    • Chardon, Ohio, United States, 44024
    • Mogadore, Ohio, United States, 44260
    • Toledo, Ohio, United States, 43614
    • Toledo, Ohio, United States, 43617
    • Zanesville, Ohio, United States, 43701
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
  • Oregon
    • Eugene, Oregon, United States, 97404
    • Lake Oswego, Oregon, United States, 97035
    • Medford, Oregon, United States, 97504
    • Portland, Oregon, United States, 97219
  • Pennsylvania
    • Bensalem, Pennsylvania, United States, 19020
    • Fleetwood, Pennsylvania, United States, 19522
    • Philadelphia, Pennsylvania, United States, 19148
    • Philadelphia, Pennsylvania, United States, 19142
    • Philadelphia, Pennsylvania, United States, 19138
    • Ridley Park, Pennsylvania, United States, 19078
  • Rhode Island
    • Cranston, Rhode Island, United States, 02920
    • East Providence, Rhode Island, United States, 02914
  • South Carolina
    • Bamberg, South Carolina, United States, 29003
    • Greer, South Carolina, United States, 29651
    • Simpsonville, South Carolina, United States, 29681
    • Spartanburg, South Carolina, United States, 29302
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
    • Clarksville, Tennessee, United States, 37043
    • Ducktown, Tennessee, United States, 37326
    • Johnson City, Tennessee, United States, 37601
    • New Tazewell, Tennessee, United States, 37825
    • Savannah, Tennessee, United States, 38372
    • Selmer, Tennessee, United States, 38375
  • Texas
    • Austin, Texas, United States, 78728
    • Beaumont, Texas, United States, 77701
    • Colleyville, Texas, United States, 76034
    • El Paso, Texas, United States, 79925
    • Fort Worth, Texas, United States, 76135
    • San Angelo, Texas, United States, 76904
    • San Antonio, Texas, United States, 78233
  • Utah
    • Salt Lake City, Utah, United States, 84102
  • Virginia
    • Christianburg, Virginia, United States, 24073
    • Mechanicsville, Virginia, United States, 23111
    • Newport News, Virginia, United States, 23606
    • Richmond, Virginia, United States, 23226
  • Washington
    • Spokane, Washington, United States, 99204
    • Spokane, Washington, United States, 99216
    • Spokane, Washington, United States, 99207
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53125
    • New Berlin, Wisconsin, United States, 53151

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ambulatory subject who does not require intravenous antibiotic therapy.
• Subject who has a medical history of chronic bronchitis.
• A history of regular medication use (>=3 consecutive months within the past 2 years) to treat pulmonary disease.
• Subject must have evidence of pulmonary function test abnormalities.
• The onset of signs and symptoms of the current exacerbation must occur within 14 days before Evaluation 1.

Exclusion Criteria:

• Medical history of hypersensitivity, allergic or adverse reactions to clarithromycin, erythromycin, or any of the macrolide antibiotics.
• A female who is pregnant or is lactating.
• Subject who has suspected or known (positive chest radiograph) pneumonia.
• Subject who has evidence of significant bronchiectasis (by CT) or atelectasis, active tuberculosis or other mycobacterial infection, bullous emphysema, pulmonary embolism, lung abscess, tumor (primary or metastatic) involving the lung, pleural effusion, or cystic fibrosis that could confound the assessment of signs and symptoms of ABECB.
• Subject who requires parenteral antibiotic therapy.
• Subject who requires hospitalization for treatment of current episode of ABECB.
• Subject who has any other infection or condition, which necessitates use of a concomitant systemic antibiotic.
• Subject who has any underlying condition/disease, which would be likely to interfere with the completion of the course or absorption of study drug therapy or follow-up.
• Subject who has a severe or complicated lower respiratory tract infection or a severely compromised respiratory status (i.e., oxygen dependent, requiring hospitalization).
• Known significant renal or hepatic impairment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A	Drug: clarithromycin extended-release tablets; 5-day course of clarithromycin extended-release tablets (2 x 500 mg QD); Other Names: Biaxin; clarithromycin; ABT-268
Active Comparator: B	Drug: clarithromycin immediate-release tablets; 7-day course of clarithromycin immediate-release tablets (1 x 500 mg BID); Other Names: Biaxin; clarithromycin; ABT-268

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical Response	23 days
Bacteriologic Response	23 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events assessment	42 days with follow-up to a satisfactory conclusion
Physical exam; Vital signs; Use of other medications and supplements	42 days
Laboratory evaluations	23 days

Collaborators and Investigators

• Sponsor: Abbott

Study record dates

Study Major Dates

• Study Start: December 1, 2002
• Primary Completion (Actual): April 1, 2004

Study Registration Dates

• First Submitted: March 24, 2008
• First Submitted That Met QC Criteria: March 26, 2008
• First Posted (Estimate): March 27, 2008

Study Record Updates

• Last Update Posted (Estimate): March 27, 2008
• Last Update Submitted That Met QC Criteria: March 26, 2008
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Bronchial Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Acute Disease; Bronchitis; Bronchitis, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Clarithromycin
• Other Study ID Numbers: M02-472