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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.
Sponsored by: 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

MedlinePlus related topics: Bronchitis
Drug Information available for: Clarithromycin
U.S. FDA Resources
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.

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

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Sponsors and Collaborators
Abbott
  More Information

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  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Clarithromycin
Bronchitis, Chronic
Lung Diseases, Obstructive
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Bronchitis
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action
Bronchial Diseases
Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009