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Telithromycin in Acute Exacerbation of Chronic Bronchitis

Primary Purpose

Bronchitis, Chronic

Status
Terminated
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Telithromycin
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchitis, Chronic

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

telithromycin

Outcomes

Primary Outcome Measures

Percentage of clinical success (cure + improvement) at TOC visit (D12-19),clinical success at TOC visit in at risk sub-populations, clinical success at follow up visit (D25-35), reinfection rates,discontinuation of treatment rates, compliance

Secondary Outcome Measures

Safety assessment of telithromycin (Safety will be assessed on the basis of serious and non serious adverse events)

Full Information

First Posted
February 6, 2006
Last Updated
December 8, 2009
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00288223
Brief Title
Telithromycin in Acute Exacerbation of Chronic Bronchitis
Official Title
Multicenter Non Comparative Phase IV Study on the Safety and Efficacy of Telithromycin 800 mg Per Day for 5 Days in the Treatment of Acute Exacerbation of Chronic Bronchitis in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Terminated
Study Start Date
January 2006 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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

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
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
telithromycin
Intervention Type
Drug
Intervention Name(s)
Telithromycin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of clinical success (cure + improvement) at TOC visit (D12-19),clinical success at TOC visit in at risk sub-populations, clinical success at follow up visit (D25-35), reinfection rates,discontinuation of treatment rates, compliance
Time Frame
D12-D19 (efficacy assessment) and D25-D35 (telephone follow-up)
Secondary Outcome Measure Information:
Title
Safety assessment of telithromycin (Safety will be assessed on the basis of serious and non serious adverse events)
Time Frame
At V3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edibe Taylan
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

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Telithromycin in Acute Exacerbation of Chronic Bronchitis

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