Telithromycin: in the Treatment of Acute Exacerbation of Chronic Bronchitis in Adult Outpatients With COPD - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00538148

Purpose

Non-inferiority efficacy of telithromycin versus azithromycin

Condition	Intervention	Phase
Bronchitis, Chronic	Drug: Telithromycin	Phase IV

MedlinePlus related topics: Bronchitis

Drug Information available for: Azithromycin Telithromycin

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment
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.

Further study details as provided by Sanofi-Aventis:

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00538148

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Philippe Nicol

Sanofi-Aventis

More Information

clinicalstudyresults.org This link exits the ClinicalTrials.gov site

Study ID Numbers:	HMR3647A_4014
Study First Received:	October 1, 2007
Last Updated:	October 3, 2007
ClinicalTrials.gov Identifier:	NCT00538148
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Acute Disease
Bronchitis, Chronic
Lung Diseases, Obstructive
Respiratory Tract Infections
Respiratory Tract Diseases

Azithromycin
Lung Diseases
Bronchitis
Telithromycin
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Disease Attributes
Pathologic Processes

Bronchial Diseases
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009