NCT00255983 is a Phase 3 clinical trial of Faropenem medoxomil in Chronic Bronchitis, sponsored by Replidyne.

Who is sponsoring NCT00255983?

NCT00255983 is sponsored by Replidyne.

What drugs are being tested in NCT00255983?

Interventions in NCT00255983: Faropenem medoxomil, placebo.

What condition does NCT00255983 study?

NCT00255983 studies Chronic Bronchitis.

Is NCT00255983 still recruiting?

NCT00255983 is currently terminated. Last updated 30 May 2008.

Last reviewed 2008-05-30 · How we verify

NCT00255983

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 3 Last updated 30 May 2008

What this trial tests

Phase 3 trial testing Faropenem medoxomil in Chronic Bronchitis in 491 participants. Terminated before completion.

Timeline

1 December 2005

Primary endpoint
1 May 2008

1 June 2008

Quick facts

Lead sponsor	Replidyne
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	491
Start date	1 December 2005
Primary completion	1 May 2008
Estimated completion	1 June 2008
Sites	1 location across United States

Drugs / interventions tested

Faropenem medoxomil — full drug profile →
placebo

Conditions studied

Chronic Bronchitis — all drugs for Chronic Bronchitis →

Sponsor

Replidyne

Who can join

35 and older, any sex, with Chronic Bronchitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Antibiotics for exacerbations of chronic obstructive pulmonary disease.
Vollenweider DJ, Frei A, Steurer-Stey CA, Garcia-Aymerich J, et al · · 2018 · cited 55× · PMID 30371937 · DOI 10.1002/14651858.cd010257.pub2

Verify or expand the search:

Other recruiting trials for Chronic Bronchitis

Currently open trials in the same condition.

NCT07068438 — Clinical Study of the Pulsed Electric Field Ablation System in Chronic Obstructive Pulmonary Disease · NA · recruiting
NCT03049202 — BROnchoalveolar Investigations of Never-smokers With Chronic Obstruction From the Swedish CardioPulmonary bioImage Study · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00255983 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Replidyne
Last refreshed: 30 May 2008

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00255983.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing