Back to resultsTelithromycin: in the Treatment of Acute Exacerbation of Chronic Bronchitis in Adult Outpatients With COPD
Primary Purpose
Bronchitis, Chronic
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Telithromycin
Sponsored by
About this trial
This is an interventional treatment trial for Bronchitis, Chronic
Eligibility Criteria
Inclusion Criteria:
- 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).
- Patients with sputum specimens collected at inclusion for gram stain and bacteriological culture.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sites / Locations
Outcomes
Primary Outcome Measures
Principal efficacy criterion: clinical outcome - Main secondary efficacy criteria: - Bacteriological response at TOC visit; - Time to relapse up to 6 months after inclusion.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00538148
Brief Title
Telithromycin: in the Treatment of Acute Exacerbation of Chronic Bronchitis in Adult Outpatients With COPD
Official Title
A Multicenter, Multinational, Randomized, DB Controlled Study of the Efficacy & Safety of Oral Telithromycin 800 mg Once QD for 5 Days vs Azithromycin in the Treatment of Acute Exacerbation of Chronic Bronchitis in Adult Outpatients With COPD.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
September 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Non-inferiority efficacy of telithromycin versus azithromycin
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchitis, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
668 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Telithromycin
Primary Outcome Measure Information:
Title
Principal efficacy criterion: clinical outcome - Main secondary efficacy criteria: - Bacteriological response at TOC visit; - Time to relapse up to 6 months after inclusion.
Time Frame
At TOC visit (Day 17-Day 21).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Patients with sputum specimens collected at inclusion for gram stain and bacteriological culture.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Telithromycin: in the Treatment of Acute Exacerbation of Chronic Bronchitis in Adult Outpatients With COPD
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