Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00042718
Other study ID # CR002650
Secondary ID
Status Completed
Phase Phase 3
First received August 5, 2002
Last updated April 26, 2010
Start date November 2001
Est. completion date August 2003

Study information

Verified date April 2010
Source Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Description:

This is a randomized, double-blind, multicenter treatment study to evaluate the efficacy and safety of high-dose, short-course oral levofloxacin treatment versus treatment with other oral antibiotics in acute bacterial exacerbation of chronic bronchitis (ABECB). This study evaluates the use of high-dose (750 milligrams) and short-course (3 or 5 days) levofloxacin compared with conventional doses and schedules of other effective antibiotics for controlling acute bacterial infections in patients with chronic bronchitis, The study will divide the 700 patients into two groups--one group with less severe (uncomplicated) chronic bronchitis, and one with more severe (complicated) chronic bronchitis. Patients with uncomplicated disease will receive levofloxacin 750 mg once daily for 3 days or azithromycin 250 mg twice a day for 1 day and then 250 mg once a day for 4 more days. Patients with complicated disease will receive levofloxacin 750 mg once daily for 5 days or amoxicillin/ clavulanate (875/125 mg) twice daily for 10 days. All patients will take study medication orally. Effectiveness will be measured by comparing the patient's signs and symptoms present at the Test-of-Cure Visits (study days 13 - 22) with those observed at the Study Entry Visit. Safety will be evaluated throughout the study on the basis of the occurrence and severity of unexpected and undesirable events as well as by laboratory tests and physical examinations. The hypothesis of the study is that a shorter course (3 days) of 750 mg levofloxacin will be at least as effective and well tolerated as azithromycin for 5 days for uncomplicated ABECB, and that 750 mg of levofloxacin for 5 days will be at least as effective and well tolerated as amoxicillin/ clavulanate for 10 days for curing complicated ABECB cases.

Uncomplicated ABECB: Oral doses of levofloxacin 750 mg once daily for 3 days, or azithromycin 250 mg twice daily on day 1, then 250 mg once daily on days 2 - 5. Complicated ABECB: Oral doses of levofloxacin 750 mg once daily for 5 days, or amoxicillin/clavulante 875/125 mg once daily for 10 days.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Drug:
levofloxacin, azithromycin, amoxicillin/clavulanate


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. PriCara, Unit of Ortho-McNeil, Inc.

Outcome

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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05533931 - Resistive Breathing Versus Inspiratory Hold Technique in Patients With Chronic Bronchitis N/A
Completed NCT01420445 - Safety/Tolerability and Efficacy of YHD001 in Patients With Acute and Chronic Bronchitis Phase 2
Completed NCT01071161 - The Effect of Azithromycin in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Productive Cough Phase 3
Completed NCT00903955 - Mucus Dehydration and Evolution of Chronic Obstructive Pulmonary Disease (COPD) Lung Disease N/A
Terminated NCT00524095 - Bronchiectasis in Chronic Obstructive Pulmonary Disease (COPD) Patients: Role of Prophylaxis Phase 2
Completed NCT00129883 - Adherence to Guidelines for Antibiotic Use in Respiratory Infections at Hospitals N/A
Recruiting NCT05075057 - Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in Patients Aged ≥60 Years With Chronic Bronchitis and COPD Phase 4
Recruiting NCT05075083 - Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in Elderly People With Chronic Bronchitis and COPD Phase 4
Terminated NCT02838108 - The Relationship Between GOLD Risk Group and Clinical Outcomes in a Community-based COPD Cohort
Completed NCT02128529 - Epidemiology of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease (COPD) N/A
Completed NCT00298389 - Macrophage Phagocytosis in COPD
Withdrawn NCT00298402 - Macrophages in Smokers' Lung N/A
Terminated NCT00132951 - KEYS: Study Comparing Clinical Health Outcomes of Telithromycin Versus Azithromycin in Outpatients With Community-acquired Lower Respiratory Tract Infections Phase 4
Active, not recruiting NCT01969344 - Study of COPD Subgroups and Biomarkers
Completed NCT00680056 - Add-on Effects of Tiotropium Over Formoterol in Exercise Tolerance on Chronic Obstructive Pulmonary Disease Patients Phase 4
Completed NCT00106080 - Improving the Quality of End-of-Life Communication for Patients With Chronic Obstructive Pulmonary Disease (COPD) N/A
Completed NCT02099799 - The Effect of Physical Activity Promotion on Short and Long-term Outcomes in COPD N/A
Completed NCT00342030 - Dietary and Genetic Factors in Asthma & Chronic Bronchitis in a Cohort of Chinese Singaporeans N/A
Withdrawn NCT02341183 - Novel Therapies for Muco-Obstructive Lung Diseases: Testing the Transnasal Pulmonary Delivery Device in COPD/CB Subjects N/A
Completed NCT00876577 - VICTOR - Avelox® Intravenous (i.v.) in Acute Exacerbations of Chronic Bronchitis N/A