Telithromycin in Acute Exacerbation of Chronic Bronchitis

NCT00288223 | Terminated Phase 4

• 1 other identifier: HMR3647A_4022
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

  D12-D19 (efficacy assessment) and D25-D35 (telephone follow-up)

Secondary Outcomes (1)

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

  At V3

Study Arms (1)

1

EXPERIMENTAL

telithromycin

Drug: Telithromycin

Interventions

Telithromycin 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.

1

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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,
• 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:

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bronchitis, Chronic

Interventions

telithromycin

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Edibe Taylan

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 6, 2006
• First Posted: February 7, 2006
• Study Start: January 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: December 9, 2009

Record last verified: 2009-12

Locations

TU (1)