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Two-Stage Study to Assess the Efficacy and Safety of 12 Weeks of Treatment With PEP03 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT00219648 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2005-09-22

No results posted yet for this study

Summary

PEP03 is a new chemical entity developed as a highly selective, potent, and orally active 5-LO inhibitor. PEP03 exerts its action by blocking the generation of both cysteinyl LTs and LTB4. These LTs have been associated with the inflammatory response in the lung and with the clinical sequelae, including bronchospasm. Preclinical pharmacological in- vitro, ex-vivo and in-vivo testing indicates that PEP03 has multiple beneficial actions including prevention of bronchoconstriction, and reduction of vascular leakage, cellular infiltration, and bronchial hyperresponsiveness.

Clinical studies in asthmatic patients indicate that PEP03 improved FEV1 and other secondary endpoints, such as morning and evening peak flow, daytime and nighttime symptoms score, beta-agonist use, physician's and patient's global impression of change. Since leukotrienes have been suggested to be involved in the pathophysiology of COPD, this study is designed to explore the clinical utility of PEP03 for the treatment of moderate COPD.6; 7; 8; 9

Conditions

Interventions

DRUG

PEP03

Sponsors & Collaborators

  • PharmaEngine

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00219648 on ClinicalTrials.gov