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.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00645086
First received: March 24, 2008
Last updated: March 26, 2008
Last verified: March 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


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
Active Comparator: A Drug: clarithromycin extended-release tablets
5-day course of clarithromycin extended-release tablets (2 x 500 mg QD)
Other Names:
  • ABT-268
  • Biaxin
  • clarithromycin
Active Comparator: B Drug: clarithromycin immediate-release tablets
7-day course of clarithromycin immediate-release tablets (1 x 500 mg BID)
Other Names:
  • ABT-268
  • Biaxin
  • clarithromycin

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645086

  Show 146 Study Locations
Sponsors and Collaborators
Abbott
  More Information

No publications provided

Responsible Party: Angela M Nilius, Ph.D., Abbott
ClinicalTrials.gov Identifier: NCT00645086     History of Changes
Other Study ID Numbers: M02-472
Study First Received: March 24, 2008
Last Updated: March 26, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bronchitis
Bronchitis, Chronic
Bronchial Diseases
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections
Clarithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014