NCT05572333

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: EpiEndo Pharmaceuticals · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Chronic Obstructive Pulmonary Disease
• COPD

Interventions

Type	Name	Description
DRUG	EP395	Capsule for oral use
DRUG	Placebo	Capsule for oral use

Timeline

• Start date: 2022-11-22
• Primary completion: 2023-11-24
• Completion: 2023-11-24
• First posted: 2022-10-07
• Last updated: 2023-11-29

Locations

6 sites across 2 countries: Germany, United Kingdom