COPD Clinical Trial
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)
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
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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