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

Study Overview
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Brief Summary
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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
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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
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Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB).

Intervention / Treatment
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* Drug: clarithromycin extended-release tablets
* Drug: clarithromycin immediate-release tablets


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: clarithromycin extended-release tablets<br>* 5-day course of clarithromycin extended-release tablets (2 x 500 mg QD)<br>* Other names: clarithromycin;|
| Active Comparator: B<br> | Drug: clarithromycin immediate-release tablets<br>* 7-day course of clarithromycin immediate-release tablets (1 x 500 mg BID)<br>* Other names: clarithromycin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Response |  | 23 days | 
| Bacteriologic Response |  | 23 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |