Actively Recruiting
Effect of Ensifentrine on Sputum Markers of Inflammation in COPD
Led by Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA · Updated on 2026-05-13
56
Participants Needed
3
Research Sites
261 weeks
Total Duration
On this page
Sponsors
V
Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA
Lead Sponsor
U
University of Alabama at Birmingham
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Ensifentrine on Sputum Markers of Inflammation in COPD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients 40-80 years of age with a history of cigarette smoking 6510 pack years and an established clinical history of COPD with symptoms compatible with COPD
- COPD severity defined by pre- and post-albuterol FEV1/FVC ratio <0.70 and post-albuterol FEV1 30% to 80% of predicted normal
- Regular use of bronchodilator COPD therapy (e.g., LAMA, LABA, ICS) for at least 4 weeks prior to screening and agree to use study supplied once daily COPD maintenance therapy during study
- Capable of using the jet nebulizer correctly and complying with study procedures
- Ability to perform acceptable spirometry and produce sputum samples during induced sputum procedure
You will not qualify if you...
- Any lung disease other than COPD such as current asthma, interstitial lung diseases, cystic fibrosis, or significant bronchiectasis
- Hospitalization for COPD, pneumonia, or COVID-19 within 12 weeks prior to screening or active COVID-19 infection at screening
- Liver enzyme abnormalities: ALT 2 x upper limit of normal, alkaline phosphatase and/or bilirubin >1.5 x ULN (except isolated bilirubin with specific conditions)
- HIV infection or other immunodeficiency
- History of cancer within 5 years except certain skin cancers
- Significant ECG abnormalities including prolonged QT interval or history of significant cardiac arrhythmia
- Known poor outcomes with sputum induction or hypersensitivity to ensifentrine or other study medications
- Not suitable for study COPD maintenance therapy per label warnings
- Taking prohibited medications or prior receipt of ensifentrine nebulized study medication
- Use of experimental drugs or medical devices within 30 days prior to screening
- Any other clinically significant medical condition or abnormal findings making participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35205
Actively Recruiting
2
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
3
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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