Two-Stage Study to Assess the Efficacy and Safety of 12 Weeks of Treatment With PEP03 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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|ClinicalTrials.gov Identifier: NCT00219648|
Recruitment Status : Unknown
Verified September 2005 by PharmaEngine.
Recruitment status was: Recruiting
First Posted : September 22, 2005
Last Update Posted : September 22, 2005
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
|Condition or disease||Intervention/treatment||Phase|
|COPD||Drug: PEP03||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose- Finding, Two-Stage Study to Assess the Efficacy and Safety of 12 Weeks of Treatment With PEP03 in Patients With Chronic Obstructive Pulmonary Disease (COPD)|
|Study Start Date :||September 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00219648
|Chang Gung Memorial Hospital||Recruiting|
|Contact: Han-Pin Kuo, MD, PH D 03-328-1200 ext 8467 email@example.com|
|Principal Investigator: Han-Pin Kuo, MD,PHD|