Chronic Bronchitis Clinical Trial
The purpose of this study is to evaluate the safety and effectiveness of four oral antibiotic treatment regimens for bacterial infections in patients with chronic bronchitis. The study goals are to demonstrate that 1) levofloxacin 750 mg once daily for three days is no worse than azithromycin 250 mg twice a day for one day and then 250 mg once a day for four more days, and 2) levofloxacin 750 mg once daily for five days is no worse than amoxicillin/ clavulanate (875/125 mg) twice daily for 10 days.
Status | Completed |
Enrollment | 659 |
Est. completion date | August 2003 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - History of chronic bronchitis - Diagnosis of Type-1 or Type-2 acute bacterial exacerbation (worsening) of chronic bronchitis (ABECB) with at least the presence of both increased sputum production and increased sputum purulence with evidence of inflammatory cells - If female, must be postmenopausal, surgically sterile, or practicing an effective method of birth control Exclusion Criteria: - Diagnosis of bronchial asthma - Allergy or serious adverse reaction to any of the study medications or other antibiotics - Failed treatment for pneumonia or acute bacterial exacerbation (worsening) of chronic bronchitis ABECB in three months prior to enrollment in the study with any of the study medications or other antibiotics - Can not tolerate medication taken by mouth |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | PriCara, Unit of Ortho-McNeil, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical response rates based on signs and symptoms at posttherapy visit. | |||
Secondary | Microbiologic eradication rates at posttherapy visit |
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