NCT00257140

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of levofloxacin, an antibiotic, compared with cefaclor, another antibiotic, in the treatment of adults with chronic bronchitis experiencing rapid onset of worsening of symptoms caused by bacteria.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
367

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 1931

Longer than P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1931

Completed
63.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 1994

Completed
11.4 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2005

Completed
Last Updated

June 10, 2011

Status Verified

January 1, 2011

First QC Date

November 18, 2005

Last Update Submit

June 8, 2011

Conditions

BronchitisBronchitis, Chronic

Keywords

Bronchitischronic bronchitislung diseasesrespiratory tract infectionsbronchial diseasesantibacterial agentsquinoloneslevofloxacin

Outcome Measures

Primary Outcomes (1)

  • Rate of elimination of disease-causing bacteria, by patient, and by type of bacteria, 5 - 7 days after the last dose of study drug.

Secondary Outcomes (1)

  • Clinical response rate (reduction in signs and symptoms) at post-therapy (5 - 7 days after the last dose of study drug). Incidence of adverse events; changes in physical examination and laboratory tests after treatment with the study drug.

Interventions

levofloxacinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of chronic bronchitis with a rapid onset of worsening of symptoms caused by bacteria
  • history of chronic obstructive lung disease (chronic bronchitis and/or emphysema)
  • recent increase in cough
  • change in type of sputum (the mucus produced on coughing) and/or an increase in the production of sputum
  • received previous antibiotic treatment if the previous treatment lasted for 24 hours or less, or if the previous treatment lasted longer than 24 hours but there was no improvement or stabilization of the disease.

You may not qualify if:

  • Illness requiring antibiotic treatment by injection into a vein, beneath the skin, or into a muscle, or has a requirement of an antibiotic medication taken orally in addition to the study drug
  • infection due to bacteria known (prior to the start of the study) to be resistant to the study drug
  • previous allergic or serious adverse reaction to similar antibiotics
  • diagnosis of pneumonia, determined by a chest x-ray at the start of the trial
  • has cystic fibrosis, seizure disorders, kidney disease, or an unstable psychiatric condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Habib MP, Gentry LO, et al. Multicenter, randomized study comparing efficacy and safety of oral levofloxacin and cefaclor in treatment of acute bacterial exacerbations of chronic bronchitis, Infectious Diseases in Clinical Practice 1998;7:101-109

    RESULT

Related Links

MeSH Terms

Conditions

BronchitisBronchitis, ChronicLung DiseasesRespiratory Tract InfectionsBronchial Diseases

Interventions

Levofloxacin

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesLung Diseases, ObstructivePulmonary Disease, Chronic ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OfloxacinFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 18, 2005

First Posted

November 22, 2005

Study Start

June 1, 1931

Study Completion

July 1, 1994

Last Updated

June 10, 2011

Record last verified: 2011-01