Telithromycin: in the Treatment of Acute Exacerbation of Chronic Bronchitis in Adult Outpatients With COPD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

668 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2004-09-30

Brief Summary

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Non-inferiority efficacy of telithromycin versus azithromycin

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Detailed Description

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Conditions

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Bronchitis, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Telithromycin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No