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Clinical Trial to Investigate the Safety and Tolerability of EP395 in Patients With COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:
A Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety and Tolerability of EP395 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Summary

The aim of this clinical trial is to investigate the safety and tolerability of oral, once-daily EP395 administration in COPD patients for 12 weeks.

Clinical Trial Description

This is a randomised, double-blind, placebo-controlled, multicentre study to assess the safety and tolerability of EP395 in COPD patients. In this study, EP395 will be administered to COPD patients for the first time. Patients will receive either EP395 or placebo as oral capsules once-daily for 12 weeks. Safety and tolerability will be assessed, as well as effect on lung function, lung inflammation and systemic inflammation. Patients' symptoms and quality of life will be assessed with questionnaires. In a sub-set of patients, bronchoscopies will be conducted, to investigate exploratory biomarkers in bronchial brushings and bronchoalveolar lavage. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05572333
Study type Interventional
Source EpiEndo Pharmaceuticals
Contact
Status Completed
Phase Phase 2
Start date November 22, 2022
Completion date November 24, 2023
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