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

Condition(s) targeted: Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB).

Intervention: clarithromycin extended-release tablets (Drug); clarithromycin immediate-release tablets (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Abbott

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.

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.

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

Primary outcome:

Clinical Response

Bacteriologic Response

Secondary outcome:

Adverse events assessment

Physical exam; Vital signs; Use of other medications and supplements

Laboratory evaluations

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

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.

San Juan 00921-3201, Puerto Rico

Birmingham, Alabama 35242, United States

Ozark, Alabama 36360, United States

Hoover, Alabama 35216, United States

Montgomery, Alabama 36106, United States

Birmingham, Alabama 35235, United States

Columbiana, Alabama 35051, United States

Mobile, Alabama 36608, United States

Sun City West, Arizona 85375, United States

Tucson, Arizona 85712, United States

Glendale, Arizona 85306, United States

Phoenix, Arizona 85006, United States

Tucson, Arizona 85746, United States

Camden, Arkansas 71701, United States

Coquitlam, British Columbia V3K 3P4, Canada

Fresno, California 93703, United States

Lakewood, California 90712, United States

Upland, California 91786, United States

San Diego, California 92117, United States

Clovis, California 93611, United States

San Jose, California 95128, United States

Rancho Cucamonga, California 91730, United States

Temecula, California 92591, United States

Sylmar, California 91342, United States

Roseville, California 95661, United States

Corona, California 92879, United States

Torrance, California 90505, United States

Pasadena, California 91105, United States

San Diego, California 92123, United States

Fountain View, California 92708, United States

San Diego, California 92103, United States

Huntington Beach, California 92647, United States

Colorado Springs, Colorado 80909, United States

Wheat Ridge, Colorado 80033, United States

Loveland, Colorado 80538, United States

Waterbury, Connecticut 06708, United States

New Port Richey, Florida 34652, United States

Orlando, Florida 32806, United States

Miami, Florida 33186, United States

Gainesville, Florida 32605, United States

Brandon, Florida 33511, United States

Tampa, Florida 33614, United States

Panama City, Florida 32405, United States

Deland, Florida 32720, United States

Fort Lauderdale, Florida 33316, United States

Miami, Florida 33157, United States

Tallahassee, Florida 36078, United States

Largo, Florida 33770, United States

Merritt Island, Florida 32953, United States

Fort Gordon, Georgia 30905, United States

Atlanta, Georgia 30342, United States

Marietta, Georgia 30060, United States

Blue Ridge, Georgia 30513, United States

Rome, Georgia 30165-1698, United States

Coeur d'Alene, Idaho 83814, United States

Hines, Illinois 60141, United States

Chicago, Illinois 60612, United States

Orland Park, Illinois 60462, United States

Evansville, Indiana 47712, United States

Indianapolis, Indiana 46254, United States

Elkhart, Indiana 46514, United States

Wichita, Kansas 67207, United States

Murray, Kentucky 42071, United States

Lexington, Kentucky 40508, United States

Baton Rouge, Louisiana 70816, United States

New Orleans, Louisiana 70128, United States

Metairie, Louisiana 70006, United States

Sunset, Louisiana 70584, United States

Auburn, Maine 04210, United States

Winnipeg, Manitoba R3R 0C5, Canada

Chester, Maryland 21619, United States

Dewitt, Michigan 48820, United States

Livonia, Michigan 48152, United States

St. Joseph, Michigan 49085, United States

Saginaw, Michigan 48602, United States

Springfield, Missouri 65802, United States

Jefferson City, Missouri 65109, United States

St. Louis, Missouri 63110-1093, United States

Chesterfield, Missouri 63017, United States

Missoula, Montana 59804, United States

Omaha, Nebraska 68134, United States

West Caldwell, New Jersey 07007, United States

Blackwood, New Jersey 08012, United States

Toms River, New Jersey 08755, United States

Mount Laurel, New Jersey 08054, United States

Camillus, New York 13031, United States

Astoria, New York 11102, United States

Bronxville, New York 10708, United States

Buffalo, New York 14215, United States

New York, New York 10016, United States

Winston-Salem, North Carolina 27103, United States

Greensboro, North Carolina 27401, United States

Chardon, Ohio 44024, United States

Toledo, Ohio 43617, United States

Mogadore, Ohio 44260, United States

Toledo, Ohio 43614, United States

Zanesville, Ohio 43701, United States

Oklahoma City, Oklahoma 73112, United States

Scarborough, Ontario M1B 4Z8, Canada

Mississauga, Ontario L5M 2V8, Canada

Toronto, Ontario M9W 4L6, Canada

Kitchener, Ontario N2C 2N9, Canada

Markham, Ontario L6B 1A1, Canada

Lake Oswego, Oregon 97035, United States

Eugene, Oregon 97404, United States

Portland, Oregon 97219, United States

Medford, Oregon 97504, United States

Philadelphia, Pennsylvania 19142, United States

Fleetwood, Pennsylvania 19522, United States

Philadelphia, Pennsylvania 19148, United States

Bensalem, Pennsylvania 19020, United States

Philadelphia, Pennsylvania 19138, United States

Ridley Park, Pennsylvania 19078, United States

Ste-Foy, Quebec G1V 4G5, Canada

Sherbrooke, Quebec J1J 2B8, Canada

East Providence, Rhode Island 02914, United States

Cranston, Rhode Island 02920, United States

Saskatoon, Saskatchewan S7H 5M3, Canada

Simpsonville, South Carolina 29681, United States

Spartanburg, South Carolina 29302, United States

Greer, South Carolina 29651, United States

Bamberg, South Carolina 29003, United States

New Tazewell, Tennessee 37825, United States

Johnson City, Tennessee 37601, United States

Ducktown, Tennessee 37326, United States

Clarksville, Tennessee 37043, United States

Selmer, Tennessee 38375, United States

Chattanooga, Tennessee 37404, United States

Savannah, Tennessee 38372, United States

San Antonio, Texas 78233, United States

Austin, Texas 78728, United States

San Angelo, Texas 76904, United States

Beaumont, Texas 77701, United States

El Paso, Texas 79925, United States

Fort Worth, Texas 76135, United States

Colleyville, Texas 76034, United States

Salt Lake City, Utah 84102, United States

Richmond, Virginia 23226, United States

Newport News, Virginia 23606, United States

Mechanicsville, Virginia 23111, United States

Christianburg, Virginia 24073, United States

Spokane, Washington 99204, United States

Spokane, Washington 99216, United States

Spokane, Washington 99207, United States

New Berlin, Wisconsin 53151, United States

Milwaukee, Wisconsin 53125, United States

Starting date: December 2002
Last updated: March 26, 2008