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Telithromycin in Acute Exacerbation of Chronic Bronchitis
This study has been completed.
First Received: February 6, 2006   Last Updated: January 21, 2009   History of Changes
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00288223
  Purpose

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

Condition Intervention Phase
Bronchitis, Chronic
Drug: Telithromycin
Phase IV

MedlinePlus related topics: Bronchitis
Drug Information available for: Telithromycin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Sanofi-Aventis:

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 [ Time Frame: D12-D19 (efficacy assessment) and D25-D35 (telephone follow-up) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety assessment of telithromycin (Safety will be assessed on the basis of serious and non serious adverse events) [ Time Frame: At V3 ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: September 2005
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
telithromycin
Drug: 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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00288223

Locations
Turkey
Sanofi-Aventis
Istanbul, Turkey
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Edibe Taylan Sanofi-Aventis
  More Information

Additional Information:
No publications provided

Responsible Party: sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers: HMR3647A/4022
Study First Received: February 6, 2006
Last Updated: January 21, 2009
ClinicalTrials.gov Identifier: NCT00288223     History of Changes
Health Authority: Turkey: Ministry of Health

Study placed in the following topic categories:
Acute Disease
Anti-Bacterial Agents
Bronchitis, Chronic
Lung Diseases, Obstructive
Respiratory Tract Infections
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases
Bronchitis
Telithromycin
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:
Acute Disease
Anti-Infective Agents
Disease Attributes
Bronchial Diseases
Pharmacologic Actions
Telithromycin
Bronchitis, Chronic
Anti-Bacterial Agents
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses
Lung Diseases
Bronchitis
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on May 07, 2009