Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB).Phase 3NCT00645086

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 3 study testing clarithromycin extended-release tablets and clarithromycin immediate-release tablets in people with Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB)., run by Abbott at 146 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB).
What is being tested?: clarithromycin extended-release tablets and clarithromycin immediate-release tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 465 participants
Where: 146 sitesin 3 countries
Study dates: Dec 2002to Apr 2004
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 10Show fewer

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.

Trial locations and contacts

146 sites in 3 countries.

Country

City, postcode or hospital

146 sites in 3 countries

United States135 sites

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

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Canada10 sites

Study site
Coquitlam, British Columbia, V3K 3P4
Study site
Kitchener, Ontario, N2C 2N9
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Markham, Ontario, L6B 1A1
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Mississauga, Ontario, L5M 2V8
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Saskatoon, Saskatchewan, S7H 5M3
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Scarborough Village, Ontario, M1B 4Z8
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Sherbrooke, Quebec, J1J 2B8
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Ste-Foy, Quebec, G1V 4G5
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Toronto, Ontario, M9W 4L6
Study site
Winnipeg, Manitoba, R3R 0C5

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Puerto Rico1 site

Study site
San Juan, 00921-3201

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About this study

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.

Conditions: Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB).
Being tested: clarithromycin extended-release tablets, clarithromycin immediate-release tablets

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

clarithromycin extended-release tabletsDrug
Also called ABT-268, Biaxin, clarithromycin
5-day course of clarithromycin extended-release tablets (2 x 500 mg QD)
clarithromycin immediate-release tabletsDrug
Also called ABT-268, Biaxin, clarithromycin
7-day course of clarithromycin immediate-release tablets (1 x 500 mg BID)

Study groups in NCT00645086
Study group	Role	What they receive
A	Active comparator	Not described Receives: Drug: clarithromycin extended-release tablets
B	Active comparator	Not described Receives: Drug: clarithromycin immediate-release tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical Response
Measured: 23 days
Bacteriologic Response
Measured: 23 days

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2002Apr 2004

First posted27 Mar 2008 (estimated)
Study startDec 2002
Primary completionApr 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB).Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 465 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00645086
Sponsor's protocol ID: M02-472
Status last verified: Mar 2008
First submitted: 24 Mar 2008
Last updated: 27 Mar 2008
Results posted: No

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00645086
Acronym / sponsor ID: M02-472
Conditions: Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB).
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 465 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Dec 2002
Primary completion: Apr 2004 (actual)
First posted: 27 Mar 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
A	Active comparator	Drug: clarithromycin extended-release tablets
B	Active comparator	Drug: clarithromycin immediate-release tablets

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
clarithromycin extended-release tabletsAlso: ABT-268, Biaxin, clarithromycin5-day course of clarithromycin extended-release tablets (2 x 500 mg QD)	Drug	A
clarithromycin immediate-release tabletsAlso: ABT-268, Biaxin, clarithromycin7-day course of clarithromycin immediate-release tablets (1 x 500 mg BID)	Drug	B

Primary outcome

Clinical Response
Time frame: 23 days
Bacteriologic Response
Time frame: 23 days

3 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2008.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

146 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 146 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Response (time frame: 23 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00645086.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2008.