Telithromycin in Acute Exacerbation of Chronic Bronchitis

NCT ID: NCT00288223

Last Updated: 2009-12-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2007-01-31

Brief Summary

Study objectives:

• to document the clinical efficacy of telithromycin(800 mg per day for 5 days) at Test Of the Cure (TOC)visit (D12-D19), in acute exacerbation of chronic bronchitis.
• to assess the long-term clinical efficacy of telithromycin by telephone at D25-D35 (V3)
• to assess the safety of telithromycin

Conditions

Bronchitis, Chronic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

telithromycin

Group Type: EXPERIMENTAL

Telithromycin

Intervention Type: DRUG

one daily intake of 800 mg (i.e. 2 x 400 mg tablets) per os in a single intake with a meal for 5 days.

Interventions

Telithromycin

one daily intake of 800 mg (i.e. 2 x 400 mg tablets) per os in a single intake with a meal for 5 days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Outpatients,
• With a documented history of chronic bronchitis defined by one expectoration daily for at least three consecutive months over at least two consecutive years
• Presenting with an evident acute exacerbation of their disease defined by the presence of at least two of Anthonisen's criteria:

• exacerbation of dyspnea,
• increase in the expectoration volume,
• increase in the expectoration purulence,

Exclusion Criteria

• Acute bronchitis,
• Chronic obstructive pulmonary disease, those having FEV1 value <35% (FEV1: Forced Expiratory Volume in 1 second)
• Suspected pneumonia or bronchial pneumonia,
• Paroxysmal asthma or continuous dyspnea in asthma,
• Cystic fibrosis,
• Active tuberculosis,
• Lung cancer or lung metastasis,
• Severe bronchiectasia,
• Acute respiratory decompensation,
• Chronic respiratory insufficiency associated with resting hypoxemia,
• Patients requiring hospitalization for parenteral antibiotic treatment
• Patients with suspected or known bacterial infection other than study diseases, as well as associated systemic or intra-tracheal antibiotic treatment other than study treatment,
• Participating in another clinical study with any product within 30 days before the inclusion of study
• Known immunosuppression (AIDS and/or CD4+ lymphocytes < 200/mm3, neutropenia <1500/mm3, blood diseases or terminal stage cancer)
• Cardiovasculary, neurologic or other severe diseases interfering with the compliance with study protocol or confusing with results.

Conditions associated with study medications:

• Hypersensitivity against telithromycin , macrolides or any of the excipients,
• Congenital long QT syndrome or family history of congenital long QT syndrome (this possibility should be excluded with normal ECG) or known acquired QT interval prolongation,
• Treatment with CYP3A4 inducers (rifampicin, carbamazepine, phenytoin, phenobarbital, St-John's-wort) within 2 weeks prior to the study inclusion
• Possibility of treatment with ergot alkaloid derivatives, terfenadine, astemizole, pimozide, cisapride, simvastatin, athorvastatin or lovastatin during studies
• Congenital galactosemia, lactase deficiency glucose or galactose malabsorption syndrome,
• Pregnant or lactating women,
• Women with childbearing potential (e.g. ovulating, pre-menopausal or not surgically sterilized) and do not employ any effective contraception method The patients may not participate to the study more than once. The patients who were treated with study drugs previously may not participate to the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Edibe Taylan

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

HMR3647A_4022

Identifier Type: -

Identifier Source: org_study_id