Actively Recruiting
A Phase IIb Randomized, Double-blind, Placebo-controlled Study to Assess Safety and Efficacy of Ensifentrine-glycopyrrolate Fixed-dose Combinations Compared to Monotherapy in Adults With COPD
Led by Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA · Updated on 2026-06-03
480
Participants Needed
57
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effects of combined doses of ensifentrine and glycopyrrolate in adults with chronic obstructive pulmonary disease (COPD). This Phase IIb trial compares two doses of the combination to each drug alone and to a placebo, aiming to evaluate their ability to improve lung function in adults aged 40 to 80 years with COPD symptoms and a history of smoking. Participants will be randomly assigned to one of six groups: two groups will receive fixed combinations of ensifentrine 3 mg with either 21.25 mcg or 42.5 mcg glycopyrrolate; two groups will receive glycopyrrolate alone at one of the two doses; one group will receive ensifentrine alone; and one group will receive a placebo. All treatments are inhaled twice daily using a standard jet nebulizer over a 28-day period. The study lasts about seven weeks, including 1 to 2 weeks for screening, 4 weeks of treatment, and a 1-week follow-up. Participants will undergo lung function tests measuring forced expiratory volume in one second (FEV1) at various time points and complete questionnaires about symptoms and quality of life. Researchers will monitor safety, lung function changes, symptom improvements, and adverse events throughout the study.
CONDITIONS
Brief 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...
- Males must agree to use contraception or abstinence and avoid donating fresh unwashed semen during the study and for 30 days after
- Females must not be pregnant or breastfeeding and either not be of child-bearing potential or agree to contraceptive guidance and avoid egg donation from screening through 30 days post-study
- Current or former cigarette smokers with at least 10 pack years history who have quit smoking for at least 6 months
- Established clinical history of COPD with compatible symptoms
- Score of 2 or higher on the Modified Medical Research Council Dyspnea 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 prior to consent and willingness to continue during study
- Ability to withhold short-acting bronchodilators and certain maintenance therapies before spirometry
- Ability to use the study jet nebulizer correctly
- Ability to perform acceptable spirometry per guidelines
- Willingness and ability to attend all study visits and follow procedures
You will not qualify if you...
- 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 prior to randomization
- Use of oral or systemic COPD exacerbation therapies within 3 months prior to randomization
- History of life-threatening COPD requiring ICU admission or intubation
- Severe unstable cardiac disease or other uncontrolled significant medical conditions that could affect safety or study completion
- History of bladder outflow obstruction or catheterization within 6 months prior to randomization
- History of narrow angle glaucoma
- Hypersensitivity to aerosol medications, albuterol, ensifentrine, glycopyrrolate, anticholinergic agents, or sympathomimetic amines
- History or current malignancy within 5 years except localized skin cancers
- Significant psychiatric disease affecting study participation
- Abnormal findings on physical exam or lab tests deemed clinically significant
- Prior or current use of ensifentrine (Ohtuvayre)
- Lung surgery within 1 year prior to randomization
- Long-term oxygen use over 12 hours per day
- Pulmonary rehabilitation not stable for at least 4 weeks prior to consent
- Major surgery within 6 weeks prior to randomization or planned during the study
- History of drug or alcohol abuse within 5 years
- Severe kidney impairment (eGFR less than 30 mL/min)
- Elevated liver enzymes beyond set limits
- Recent use of experimental drugs or devices within 30 days prior to consent
- Affiliation with the investigator site or family members thereof
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 1 to 2 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive study drug treatments administered twice daily by oral inhalation for 4 weeks.
Multiple visits during treatment period
Duration - 1 week
Participants are monitored for safety and efficacy outcomes following treatment completion.
1 follow-up visit (in-person)
Trial Site Locations
Total: 57 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
Clinical Research Institute, Inc - CRN
Plymouth, Minnesota, United States, 55441-2676
Actively Recruiting
19
Midwest Chest Consultants PC
Saint Charles, Missouri, United States, 63301
Actively Recruiting
20
Midwest Clinical Research LLC
St Louis, Missouri, United States, 63141-7051
Actively Recruiting
21
The Clinical Research Center LLC - CRN
St Louis, Missouri, United States, 63141
Actively Recruiting
22
Sierra Clinical Research
Las Vegas, Nevada, United States, 89106
Terminated
23
Trialfinity Clinical Research Center
Hamilton, New Jersey, United States, 08619
Actively Recruiting
24
Horizon Family Medical Group - New Windsor Primary Care
New Windsor, New York, United States, 12553-7754
Actively Recruiting
25
American Health Research Inc
Charlotte, North Carolina, United States, 28277
Actively Recruiting
26
Clinical Research of Gastonia
Gastonia, North Carolina, United States, 28054-7481
Actively Recruiting
27
Stern Research Partners, LLC
Huntersville, North Carolina, United States, 28078
Actively Recruiting
28
Monroe Biomedical Research -343 Venus St
Monroe, North Carolina, United States, 28112-4025
Actively Recruiting
29
Carolina Research Center, Inc
Shelby, North Carolina, United States, 28150-3803
Actively Recruiting
30
Bernstein Clinical Research Center Inc
Cincinnati, Ohio, United States, 45231-4927
Actively Recruiting
31
Remington Davis Clinical Research
Columbus, Ohio, United States, 43215
Actively Recruiting
32
Advance Clinical Research
Kettering, Ohio, United States, 45439
Actively Recruiting
33
Clinical Research Associates of Central PA
DuBois, Pennsylvania, United States, 15801-2277
Actively Recruiting
34
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
35
Velocity Clinical Research - Anderson - PPDS
Anderson, South Carolina, United States, 29621-4822
Actively Recruiting
36
Pharmacorp Clinical Trials Incorporated
Charleston, South Carolina, United States, 29412
Actively Recruiting
37
Piedmont Research Partners LLC
Fort Mill, South Carolina, United States, 29707-4514
Actively Recruiting
38
Velocity Clinical Research - Gaffney - PPDS
Gaffney, South Carolina, United States, 29340-4737
Actively Recruiting
39
Lowcountry Lung and Critical Care PA
North Charleston, South Carolina, United States, 29406
Actively Recruiting
40
Monroe Biomedical Research Charleston
North Charleston, South Carolina, United States, 29406
Actively Recruiting
41
Clinical Research of Rock Hill
Rock Hill, South Carolina, United States, 29732
Actively Recruiting
42
Spartanburg Medical Research
Spartanburg, South Carolina, United States, 29303-4755
Actively Recruiting
43
Velocity Clinical Research
Spartanburg, South Carolina, United States, 29303
Actively Recruiting
44
Velocity Clinical Research - Union - PPDS
Union, South Carolina, United States, 29379
Actively Recruiting
45
Chattanooga Research & Medicine, PLLC
Chattanooga, Tennessee, United States, 37404
Actively Recruiting
46
ClinSearch - Chattanooga
Chattanooga, Tennessee, United States, 37421
Actively Recruiting
47
Clinical Trials Center of Middle Tennessee
Franklin, Tennessee, United States, 37067-5665
Actively Recruiting
48
MultiSpecialty Clinical Research, Inc
Johnson City, Tennessee, United States, 37604
Completed
49
Inquest Clinical Research
Baytown, Texas, United States, 77521
Actively Recruiting
50
Corsicana Medical Research
Corsicana, Texas, United States, 75110-2471
Actively Recruiting
51
Horizon CR: Houston Pulmonary Sleep & Allergy Associates - Cypress - ClinEdge - PPDS
Cypress, Texas, United States, 77429
Actively Recruiting
52
Greater Heights Memorial Pulmonary and Sleep
Houston, Texas, United States, 77008
Actively Recruiting
53
Houston Pulmonary Medicine Associates, PA - Biopharma Informatic - PPDS
Houston, Texas, United States, 77089
Actively Recruiting
54
Huntsville Research Institute LLC
Huntsville, Texas, United States, 77340
Actively Recruiting
55
Element Research Group
San Antonio, Texas, United States, 78258
Actively Recruiting
56
Sherman Clinical Research - 403 N. Highland Ave
Sherman, Texas, United States, 75092
Actively Recruiting
57
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
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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