A Trial to Evaluate the Efficacy and Safety of Faropenem Medoxomil In the Treatment of Chronic Bronchitis

Replidyne

Status and phase: Terminated; Phase 3

Conditions: Chronic Bronchitis

Treatments: Drug: placebo; Drug: Faropenem medoxomil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00255983

REP-FAR-005

Details and patient eligibility

About

Identifying the role of antibiotics in the treatment of subjects with a microbiologically documented acute exacerbation of chronic bronchitis (AECB) is the purpose of this clinical trial. The trial has been designed to evaluate the efficacy and safety of faropenem medoxomil versus placebo in the treatment of subjects with microbiologically documented AECB.

Full description

This is a multi-center, multi-national, prospective, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety/tolerability of faropenem medoxomil versus placebo in the treatment of subjects with a primary diagnosis of AECB. All subjects will have a pre-therapy sputum specimen obtained for culture and susceptibility testing.

Enrollment: 491 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or non-pregnant female outpatients age greater than or equal 35 years with significant COPD (GOLD criteria I, IIA or IIB), chronic cough and sputum production and an acute exacerbation

Exclusion criteria

• Gold criteria III

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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491 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

faropenem medoxomil

Treatment:

Drug: Faropenem medoxomil

2

Placebo Comparator group

Treatment:

Drug: placebo