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

Prospective, Randomized, Double-Blind Trial to Evaluate the Efficacy and Safety of Faropenem Medoxomil 600 mg PO, BID for 5 Days Versus Placebo In the Treatment of Acute Exacerbation of Chronic Bronchitis

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00255983

Enrollment

491

Registered

2005-11-21

Start date

2005-12-31

Completion date

2008-06-30

Last updated

2008-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Bronchitis

Keywords

bronchitis, AECB

Brief summary

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.

Detailed 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.

Interventions

DRUGFaropenem medoxomil

600 mg BID for 5 days

DRUGplacebo

placebo tablets BID for 5 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

35 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
• Clinical response at test of cure.	Day 8 to 12

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026