NCT00538148

Brief Summary

Non-inferiority efficacy of telithromycin versus azithromycin

Trial Health

100
On Track

Trial Health Score

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

Enrollment
668

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2002

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

November 1, 2002

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2007

Completed
Last Updated

February 17, 2012

Status Verified

February 1, 2012

Enrollment Period

1.8 years

First QC Date

October 1, 2007

Last Update Submit

February 15, 2012

Conditions

Bronchitis, Chronic

Outcome Measures

Primary Outcomes (1)

  • Principal efficacy criterion: clinical outcome - Main secondary efficacy criteria: - Bacteriological response at TOC visit; - Time to relapse up to 6 months after inclusion.

    At TOC visit (Day 17-Day 21).

Interventions

TelithromycinDRUG

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult outpatients, either sex, aged 45 years or older.
  • Patients with a documented history of chronic bronchitis with a basal FEV1 \<70% and \>35% made in the previous 12 months and who had had at least one or more AEBC in the previous year and with FEV1/FVC \<70% (lung function tests made in the previous 12 months).
  • Patients with a clinical diagnosis of acute exacerbation of chronic bronchitis presumably due to bacterial infection based on all of the following signs and symptoms of AECB: increased sputum purulence, and at least 1 of the 2 following signs and symptoms (increased dyspnea, increased sputum volume).
  • Patients with negative chest radiography (posterior/anterior and lateral views) to rule out a pneumonia within 48 hours before initiation of study medication or at the latest 24 hours after initiation of study medication (it was necessary to not include patients with pneumonia associated with AECB).
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bronchitis, Chronic

Interventions

telithromycin

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesPulmonary Disease, Chronic ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2007

First Posted

October 2, 2007

Study Start

November 1, 2002

Primary Completion

September 1, 2004

Study Completion

September 1, 2004

Last Updated

February 17, 2012

Record last verified: 2012-02