This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Telithromycin: in the Treatment of Acute Exacerbation of Chronic Bronchitis in Adult Outpatients With COPD

This study has been completed.
Information provided by (Responsible Party):
Sanofi Identifier:
First received: October 1, 2007
Last updated: February 15, 2012
Last verified: February 2012
Non-inferiority efficacy of telithromycin versus azithromycin

Condition Intervention Phase
Bronchitis, Chronic Drug: Telithromycin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by Sanofi:

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. [ Time Frame: At TOC visit (Day 17-Day 21). ]

Enrollment: 668
Study Start Date: November 2002
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00538148

Sponsors and Collaborators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi Identifier: NCT00538148     History of Changes
Other Study ID Numbers: HMR3647A_4014
Study First Received: October 1, 2007
Last Updated: February 15, 2012

Additional relevant MeSH terms:
Acute Disease
Bronchitis, Chronic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Anti-Bacterial Agents
Anti-Infective Agents processed this record on September 21, 2017