Clinical trial NCT00645086: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB).
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 465
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Clinical Response
timeFrame: 23 days
measure: Bacteriologic Response
timeFrame: 23 days
Secondary outcomes:
measure: Adverse events assessment
timeFrame: 42 days with follow-up to a satisfactory conclusion
measure: Physical exam; Vital signs; Use of other medications and supplements
timeFrame: 42 days
measure: Laboratory evaluations
timeFrame: 23 days
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Columbiana
country: United States
state: Alabama
city: Hoover
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Montgomery
country: United States
state: Alabama
city: Ozark
country: United States
state: Alabama
city: Glendale
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Sun City West
country: United States
state: Arizona
city: Tucson
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state: Arizona
city: Tucson
country: United States
state: Arizona
city: Camden
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state: Arkansas
city: Clovis
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state: California
city: Corona
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state: California
city: Fountain View
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state: California
city: Fresno
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state: California
city: Huntington Beach
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state: California
city: Lakewood
country: United States
state: California
city: Pasadena
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state: California
city: Rancho Cucamonga
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state: California
city: Roseville
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state: California
city: San Diego
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state: California
city: San Diego
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state: California
city: San Diego
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state: California
city: San Jose
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state: California
city: Sylmar
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state: California
city: Temecula
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state: California
city: Torrance
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state: California
city: Upland
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state: California
city: Colorado Springs
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state: Colorado
city: Loveland
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state: Colorado
city: Wheat Ridge
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state: Colorado
city: Waterbury
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state: Connecticut
city: Brandon
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city: Deland
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city: Fort Lauderdale
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state: Florida
city: Gainesville
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state: Florida
city: Largo
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state: Florida
city: Merritt Island
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state: Florida
city: Miami
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city: New Port Richey
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city: Atlanta
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state: Georgia
city: Blue Ridge
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state: Georgia
city: Fort Gordon
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state: Georgia
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city: Rome
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city: Coeur d'Alene
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state: Idaho
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state: Illinois
city: Hines
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city: Murray
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city: New Orleans
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city: Auburn
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state: Maine
city: Chester
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state: Maryland
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city: Livonia
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city: Saginaw
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city: St. Joseph
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city: Chesterfield
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city: Jefferson City
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city: Springfield
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state: Montana
city: Omaha
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city: Blackwood
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city: Mount Laurel
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city: Toms River
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city: Bronxville
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city: Camillus
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city: Greensboro
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state: North Carolina
city: Winston-Salem
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state: North Carolina
city: Chardon
country: United States
state: Ohio
city: Mogadore
country: United States
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city: Toledo
country: United States
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city: Toledo
country: United States
state: Ohio
city: Zanesville
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Eugene
country: United States
state: Oregon
city: Lake Oswego
country: United States
state: Oregon
city: Medford
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Bensalem
country: United States
state: Pennsylvania
city: Fleetwood
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Ridley Park
country: United States
state: Pennsylvania
city: Cranston
country: United States
state: Rhode Island
city: East Providence
country: United States
state: Rhode Island
city: Bamberg
country: United States
state: South Carolina
city: Greer
country: United States
state: South Carolina
city: Simpsonville
country: United States
state: South Carolina
city: Spartanburg
country: United States
state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Clarksville
country: United States
state: Tennessee
city: Ducktown
country: United States
state: Tennessee
city: Johnson City
country: United States
state: Tennessee
city: New Tazewell
country: United States
state: Tennessee
city: Savannah
country: United States
state: Tennessee
city: Selmer
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Beaumont
country: United States
state: Texas
city: Colleyville
country: United States
state: Texas
city: El Paso
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: San Angelo
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Christianburg
country: United States
state: Virginia
city: Mechanicsville
country: United States
state: Virginia
city: Newport News
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
city: New Berlin
country: United States
state: Wisconsin
city: Coquitlam
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Kitchener
country: Canada
state: Ontario
city: Markham
country: Canada
state: Ontario
city: Mississauga
country: Canada
state: Ontario
city: Scarborough
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Sherbrooke
country: Canada
state: Quebec
city: Ste-Foy
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
city: San Juan
country: Puerto Rico
Study officials:
References: