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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
This study has been completed.
First Received: March 24, 2008   Last Updated: March 26, 2008   History of Changes
Sponsor: Abbott
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00645086
  Purpose

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.


Condition Intervention Phase
Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB).
Drug: clarithromycin extended-release tablets
Drug: clarithromycin immediate-release tablets
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Clinical Response [ Time Frame: 23 days ] [ Designated as safety issue: No ]
  • Bacteriologic Response [ Time Frame: 23 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events assessment [ Time Frame: 42 days with follow-up to a satisfactory conclusion ] [ Designated as safety issue: Yes ]
  • Physical exam; Vital signs; Use of other medications and supplements [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
  • Laboratory evaluations [ Time Frame: 23 days ] [ Designated as safety issue: Yes ]

Enrollment: 465
Study Start Date: December 2002
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Active Comparator Drug: clarithromycin extended-release tablets
5-day course of clarithromycin extended-release tablets (2 x 500 mg QD)
B: Active Comparator Drug: clarithromycin immediate-release tablets
7-day course of clarithromycin immediate-release tablets (1 x 500 mg BID)

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00645086

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

No publications provided

Responsible Party: Abbott ( Angela M Nilius, Ph.D. )
Study ID Numbers: M02-472
Study First Received: March 24, 2008
Last Updated: March 26, 2008
ClinicalTrials.gov Identifier: NCT00645086     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acute Disease
Anti-Infective Agents
Disease Attributes
Molecular Mechanisms of Pharmacological Action
Bronchial Diseases
Enzyme Inhibitors
Pharmacologic Actions
Anti-Bacterial Agents
Bronchitis, Chronic
Clarithromycin
Protein Synthesis Inhibitors
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses
Lung Diseases
Bronchitis
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on November 27, 2009