Actively Recruiting
A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD
Led by Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA · Updated on 2026-05-13
480
Participants Needed
55
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will assess the safety and efficacy of fixed dose combinations of ensifentrine with two different glycopyrrolate dose levels compared to placebo and to the individual components of the fixed dose combinations, each administered twice a day via standard jet nebulizer, in adult subjects with chronic obstructive pulmonary disease (COPD).
CONDITIONS
Official Title
A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants must agree to use contraception or abstinence and not donate fresh unwashed semen during the study and for 30 days after
- Female participants must not be pregnant or breastfeeding and either not be of childbearing potential or agree to contraceptive guidance and not donate eggs during the study and for 30 days after
- Current or former cigarette smokers with at least 10 pack years smoking history
- History of COPD as defined by ATS/ERS guidelines with compatible symptoms
- Dyspnea score of 2 or higher on the Modified Medical Research Council (mMRC) scale at screening
- Post-bronchodilator spirometry showing FEV1/FVC ratio less than 0.70 and FEV1 between 30% and 70% of predicted normal
- Chest X-ray or CT scan within 12 months showing no significant abnormalities unrelated to COPD
- Either no maintenance therapy or stable use of LABA or LABA/ICS therapy for at least 60 days before consent
- Ability to withhold short-acting bronchodilators before spirometry and maintain use of permitted maintenance therapy as required
- Ability to correctly use the study jet nebulizer
- Ability to perform acceptable spirometry according to ATS/ERS guidelines
- Willingness and ability to attend all visits and comply with study assessments and procedures
You will not qualify if you...
- Presence of other significant pulmonary diseases besides COPD, such as asthma, tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases, or uncontrolled sleep apnea
- COPD exacerbation requiring hospitalization within 6 months before randomization
- Use of oral or systemic therapies for COPD exacerbations within 3 months before randomization
- History of life-threatening COPD requiring ICU admission or intubation
- Severe comorbidities including unstable cardiac disease, NYHA class III or IV heart disease, or uncontrolled major medical conditions
- Bladder outflow obstruction or catheterization within 6 months before randomization
- History of narrow angle glaucoma
- Hypersensitivity or intolerance to study drugs or related medications
- History or current malignancy within 5 years except localized skin cancer
- Significant psychiatric illness that prevents study completion
- Clinically significant abnormal findings on physical exam, labs, or ECG
- Prior or current use of ensifentrine (Ohtuvayre)
- Lung resection or reduction surgery within 1 year before randomization
- Long-term oxygen use over 12 hours per day
- Pulmonary rehabilitation started or changed within 4 weeks before consent or planned changes during study
- Major surgery within 6 weeks before randomization or incomplete recovery
- History of drug or alcohol abuse within 5 years before randomization
- Severe kidney impairment (eGFR less than 30 mL/min)
- Elevated liver enzymes beyond specified limits
- Use of experimental drugs or devices within 30 days before consent
- Affiliation with the investigator site or family members of site staff
AI-Screening
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Trial Site Locations
Total: 55 locations
1
SEC Clinical Research, LLC
Dothan, Alabama, United States, 36305-7375
Actively Recruiting
2
Elite Clinical Studies, LLC
Phoenix, Arizona, United States, 85018
Actively Recruiting
3
Downtown LA Research Center Inc - ClinEdge
Los Angeles, California, United States, 90017
Actively Recruiting
4
California Medical Research Associates, Inc.
Northridge, California, United States, 91324-6200
Actively Recruiting
5
Northern California Research Corp
Sacramento, California, United States, 95821-2640
Actively Recruiting
6
Clinical Research of West Florida Inc
Clearwater, Florida, United States, 33765
Actively Recruiting
7
Fleming Island Center For Clinical Research
Fleming Island, Florida, United States, 32003
Actively Recruiting
8
Florida Institute For Clinical Research LLC
Orlando, Florida, United States, 32825-4454
Actively Recruiting
9
Ormond Beach Clinical Research
Ormond Beach, Florida, United States, 32174-8196
Actively Recruiting
10
Progressive Medical Research
Port Orange, Florida, United States, 32127-5169
Actively Recruiting
11
Clinical Research of West Florida Inc - Tampa
Tampa, Florida, United States, 33606
Actively Recruiting
12
Centricity Research Columbus Georgia Multispecialty - PPDS
Columbus, Georgia, United States, 31904
Actively Recruiting
13
Southeast Lung Associates Research
Rincon, Georgia, United States, 31326
Withdrawn
14
ASHA Clinical Research - Hammond
Hammond, Indiana, United States, 46324
Actively Recruiting
15
Velocity Clinical Research - Valparaiso
Valparaiso, Indiana, United States, 46383
Actively Recruiting
16
Velocity Clinical Research (Rockville - Maryland) - PPDS
Rockville, Maryland, United States, 20854-2960
Actively Recruiting
17
Revive Research Institute, Inc
Southfield, Michigan, United States, 48075
Actively Recruiting
18
Midwest Chest Consultants PC
Saint Charles, Missouri, United States, 63301
Actively Recruiting
19
Midwest Clinical Research LLC
St Louis, Missouri, United States, 63141-7051
Actively Recruiting
20
The Clinical Research Center LLC - CRN
St Louis, Missouri, United States, 63141
Actively Recruiting
21
Sierra Clinical Research
Las Vegas, Nevada, United States, 89106
Terminated
22
Trialfinity Clinical Research Center
Hamilton, New Jersey, United States, 08619
Actively Recruiting
23
Horizon Family Medical Group - New Windsor Primary Care
New Windsor, New York, United States, 12553-7754
Actively Recruiting
24
American Health Research Inc
Charlotte, North Carolina, United States, 28277
Actively Recruiting
25
Clinical Research of Gastonia
Gastonia, North Carolina, United States, 28054-7481
Actively Recruiting
26
Stern Research Partners, LLC
Huntersville, North Carolina, United States, 28078
Actively Recruiting
27
Monroe Biomedical Research -343 Venus St
Monroe, North Carolina, United States, 28112-4025
Actively Recruiting
28
Carolina Research Center, Inc
Shelby, North Carolina, United States, 28150-3803
Actively Recruiting
29
Remington Davis Clinical Research
Columbus, Ohio, United States, 43215
Actively Recruiting
30
Advance Clinical Research
Kettering, Ohio, United States, 45439
Actively Recruiting
31
Clinical Research Associates of Central PA
DuBois, Pennsylvania, United States, 15801-2277
Actively Recruiting
32
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
33
Velocity Clinical Research - Anderson - PPDS
Anderson, South Carolina, United States, 29621-4822
Actively Recruiting
34
Pharmacorp Clinical Trials Incorporated
Charleston, South Carolina, United States, 29412
Actively Recruiting
35
Piedmont Research Partners LLC
Fort Mill, South Carolina, United States, 29707-4514
Actively Recruiting
36
Velocity Clinical Research - Gaffney - PPDS
Gaffney, South Carolina, United States, 29340-4737
Actively Recruiting
37
Lowcountry Lung and Critical Care PA
North Charleston, South Carolina, United States, 29406
Actively Recruiting
38
Monroe Biomedical Research Charleston
North Charleston, South Carolina, United States, 29406
Actively Recruiting
39
Clinical Research of Rock Hill
Rock Hill, South Carolina, United States, 29732
Actively Recruiting
40
Spartanburg Medical Research
Spartanburg, South Carolina, United States, 29303-4755
Actively Recruiting
41
Velocity Clinical Research
Spartanburg, South Carolina, United States, 29303
Actively Recruiting
42
Velocity Clinical Research - Union - PPDS
Union, South Carolina, United States, 29379
Actively Recruiting
43
Chattanooga Research & Medicine, PLLC
Chattanooga, Tennessee, United States, 37404
Actively Recruiting
44
ClinSearch - Chattanooga
Chattanooga, Tennessee, United States, 37421
Actively Recruiting
45
Clinical Trials Center of Middle Tennessee
Franklin, Tennessee, United States, 37067-5665
Actively Recruiting
46
MultiSpecialty Clinical Research, Inc
Johnson City, Tennessee, United States, 37604
Actively Recruiting
47
Inquest Clinical Research
Baytown, Texas, United States, 77521
Actively Recruiting
48
Corsicana Medical Research
Corsicana, Texas, United States, 75110-2471
Actively Recruiting
49
Horizon CR: Houston Pulmonary Sleep & Allergy Associates - Cypress - ClinEdge - PPDS
Cypress, Texas, United States, 77429
Actively Recruiting
50
Greater Heights Memorial Pulmonary and Sleep
Houston, Texas, United States, 77008
Actively Recruiting
51
Houston Pulmonary Medicine Associates, PA - Biopharma Informatic - PPDS
Houston, Texas, United States, 77089
Actively Recruiting
52
Huntsville Research Institute LLC
Huntsville, Texas, United States, 77340
Actively Recruiting
53
Element Research Group
San Antonio, Texas, United States, 78258
Actively Recruiting
54
Sherman Clinical Research - 403 N. Highland Ave
Sherman, Texas, United States, 75092
Actively Recruiting
55
Tranquil Clinical Research
Webster, Texas, United States, 77598-4085
Actively Recruiting
Research Team
V
Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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