RecruitingPhase 2NCT05270525

Effect of Ensifentrine on Sputum Markers of Inflammation in COPD

A Randomized, Double-Blind, Placebo-Controlled, Two-period Cross-over Study of the Effect of Ensifentrine on Sputum Markers of Inflammation in Patients With COPD

Sponsor

Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA

Enrollment

56 participants

Start Date

May 27, 2022

Study Type

INTERVENTIONAL

Conditions

COPD

Summary

This is a randomized, double-blind, placebo-controlled, two-period cross-over study of nebulized ensifentrine (3 mg) or placebo administered BID for two 8-week Treatment Periods. All participants with receive both ensifentrine and placebo during participation. There are 7 in-clinic visits over a total duration of up to 24 weeks participation.

Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether ensifentrine, an inhaled drug for COPD, reduces airway inflammation as measured by markers in sputum (mucus you cough up). **You may be eligible if...** - You are 40–80 years old with a confirmed diagnosis of COPD - You have at least a 10 pack-year smoking history - Your lung function tests show moderate-to-severe airflow limitation - You are already on bronchodilator therapy for COPD - You are able to use an inhaler correctly and produce a sputum sample **You may NOT be eligible if...** - Your COPD is very severe (FEV1 less than 30% predicted) - You have had a COPD flare-up or respiratory infection in the past 4 weeks - You have significant heart, liver, or kidney disease - You are unable to perform breathing tests correctly Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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