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Chronic Obstructive Pulmonary DiseasePhase 2NCT07016412

Clinical Study of Ensifentrine-Glycopyrrolate (MK-5884A/RPL554) Fixed-dose Combination Dose Ranging in Participants With COPD (MK-5884A-029/RPL554-CO-212)

A Phase 2 study testing Ensifentrine 3 mg, Glycopyrrolate 21.25 mcg and Glycopyrrolate 42.5 mcg in people with Chronic Obstructive Pulmonary Disease, run by Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA at 57 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 participants with chronic… Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
Ensifentrine 3 mg, Glycopyrrolate 21.25 mcg and Glycopyrrolate 42.5 mcg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
497 participants
Where
57 sitesUnited States
Study dates
31 Jul 2025to 17 Aug 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males are eligible to participate if they agree to use contraception or abstinence, and refrain from donating fresh unwashed semen during the study and for at least 30 days post-study
  • Females are eligible to participate if they are not pregnant, breastfeeding and if one of the following conditions apply:
  • Not a woman of child-bearing potential OR
  • Agrees to follow the contraceptive guidance from screening throughout the study and for at least 30 days post-study
  • Agrees not to donate eggs for the purpose of reproduction from screening throughout the study and for at least 30 days post-study
  • Current of former cigarette smokers with a history of smoking ≥ 10 pack years at the time of signing informed consent [number of pack years = (number of cigarettes per day / 20) × number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Pipe and/or cigar use cannot be used to calculate pack-year history. Former smokers are defined as those who have stopped smoking for at least 6 months prior to signing informed consent. Smoking cessation programs are permitted during the study
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  • Participants with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines with symptoms compatible with COPD
  • A score of ≥ 2 on the Modified Medical Research Council (mMRC) Dyspnea Scale at the Screening Visit
  • Post-bronchodilator (4 puffs of albuterol) spirometry during the Screening Period demonstrating both the following:
  • FEV1/forced vital capacity (FVC) ratio of < 0.70 AND
  • FEV1 ≥ 30 % and ≤ 70% of predicted normal
  • A posterior-anterior chest x-ray (CXR) during the Screening Period or within 12 months of signing the Informed Consent Form (ICF) showing no clinically significant abnormalities unrelated to COPD. If a CXR within the past 12 months is not available but a computed tomography (CT) scan within the same time period is available, the CT scan may be reviewed in place of a CXR
  • Participants on no maintenance/background therapy or participants on stable maintenance as either long-acting β2-agonist (LABA) or long-acting β2-agonist/Inhaled corticosteroid (LABA/ICS) therapy are eligible. Subjects taking maintenance therapy must demonstrate regular use of maintenance therapy, in any form, for at least 60 days prior to signing informed consent and agree to continue use of their current permitted LABA or LABA/ICS medication for the duration of the screening and treatment period
  • Capable of withholding from short-acting bronchodilators for 4 hours prior to spirometry testing. Participants receiving maintenance therapy with a LABA or LABA/ICS must be capable of withholding twice-daily maintenance therapy for 24 hours and once-daily maintenance therapy for 48 hours prior to initiation of any spirometry
  • Capable of using the study jet nebulizer correctly
  • Ability to perform acceptable spirometry in accordance with ATS/ERS guidelines
  • Willing and able to attend all study visits and adhere to all study assessments and procedures

Who cannot join

  • Concomitant clinically significant pulmonary disease other than COPD (i.e., asthma, tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases, sleep apnea (unless controlled with stable continuous positive airway pressure [CPAP] use), known alpha-1 antitrypsin deficiency, core pulmonale or other non-specific pulmonary disease
  • Within 6 months prior to randomization, a COPD exacerbation requiring hospitalization
  • Within 3 months prior to randomization, use of oral or systemic therapies for COPD exacerbations (for example, oral, intravenous, or intramuscular glucocorticoids, antibiotics, theophylline, and roflumilast)
  • History of life-threatening COPD, including Intensive Care Unit admission and/or requiring intubation
  • Severe comorbidities including
  • unstable cardiac disease (myocardial infarction within 1 year prior to randomization, unstable angina within 6 months prior to randomization, unstable or life-threatening arrhythmia requiring intervention within 3 months prior to randomization, diagnosis of New York Heart Association (NYHA) class III or IV heart disease, or
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  • any other clinically significant medical conditions including uncontrolled diseases (e.g., endocrine, neurological, hepatic, gastrointestinal, renal, hematological, urological, immunological, psychiatric [e.g. untreated significant depression, anxiety or history of suicidality], or ophthalmic diseases) that would, in the opinion of the Investigator, preclude the participant from safely completing the required tests or the study, or is likely to result in disease progression that would require withdrawal of the participant
  • History of or clinically significant on-going bladder outflow obstruction or history of catheterization for relief of bladder outflow obstruction within 6 months prior to randomization
  • History of narrow angle glaucoma
  • History of hypersensitivity or intolerance to aerosol medications, albuterol, ensifentrine, or glycopyrrolate or any of its excipients/components, anticholinergic agents, or sympathomimetic amines
  • History of or current malignancy of any organ system, treated or untreated within the 5 years prior to randomization, except for localized basal or squamous cell carcinoma of the skin
  • Other significant psychiatric disease that would likely result in the participant not being able to complete the study, in the opinion of the Investigator
  • Findings on physical examination that an investigator considers to be clinically significant or abnormal during the Screening Period including hematology, biochemistry, viral serology, and ECG
  • Prior or current use of Ohtuvayre (ensifentrine)
  • Previous lung resection or lung reduction surgery within 1-year of randomization
  • Long term oxygen use defined as oxygen therapy prescribed for greater than 12 hours per day. As needed oxygen use (≤ 12 hours per day) is not exclusionary
  • Pulmonary rehabilitation unless such treatment has been stable from 4 weeks prior to signing the ICF and plans to remain stable during the study. Pulmonary rehabilitation programs should not be started or completed during participation in the study
  • Major surgery (requiring general anesthesia) in the 6 weeks prior randomization, lack of full recovery from surgery at randomization, or planned surgery through the end of the study
  • Current or history of drug or alcohol abuse within the 5 years prior to randomization
  • Estimated glomerular filtration rate (eGFR) < 30 mL/min as tested during the Screening Period
  • Alanine aminotransferase (ALT) ≥ 2 × upper limit of normal (ULN), aspartate aminotransferase (AST) ≥ 2 × ULN, alkaline phosphatase and/or total bilirubin > 1.5 × ULN (participants with Gilbert's syndrome can be included with total bilirubin >1.5 × ULN as long as direct bilirubin is ≤ 1.5 × ULN)
  • Use of an experimental drug within 30 days or 5 half-lives of signing the ICF, whichever is longer, and/or participation in a study treatment-free follow-up phase of a clinical study within 30 days prior to signing the ICF
  • Use of an experimental medical device or participation in a follow-up phase of an experimental medical device clinical study within 30 days prior to informed consent
  • Affiliation with the investigator site, including an Investigator, Sub-Investigator, study coordinator, study nurse, other employee of participating investigator or study site or a family member of the aforementioned

Trial locations and contacts

57 sites in 1 country.

57 sites in 1 country

United States57 sites

  • Velocity Clinical Research - Anderson - PPDS

    Anderson, South Carolina, 29621-4822

  • Inquest Clinical Research

    Baytown, Texas, 77521

  • Pharmacorp Clinical Trials Incorporated

    Charleston, South Carolina, 29412

  • American Health Research Inc

    Charlotte, North Carolina, 28277

  • Chattanooga Research & Medicine, PLLC

    Chattanooga, Tennessee, 37404

  • ClinSearch - Chattanooga

    Chattanooga, Tennessee, 37421

  • Bernstein Clinical Research Center Inc

    Cincinnati, Ohio, 45231-4927

  • Clinical Research of West Florida Inc

    Clearwater, Florida, 33765

  • Centricity Research Columbus Georgia Multispecialty - PPDS

    Columbus, Georgia, 31904

  • Remington Davis Clinical Research

    Columbus, Ohio, 43215

  • Corsicana Medical Research

    Corsicana, Texas, 75110-2471

  • Horizon CR: Houston Pulmonary Sleep & Allergy Associates - Cypress - ClinEdge - PPDS

    Cypress, Texas, 77429

  • SEC Clinical Research, LLC

    Dothan, Alabama, 36305-7375

  • Clinical Research Associates of Central PA

    DuBois, Pennsylvania, 15801-2277

  • Fleming Island Center For Clinical Research

    Fleming Island, Florida, 32003

  • Piedmont Research Partners LLC

    Fort Mill, South Carolina, 29707-4514

  • Clinical Trials Center of Middle Tennessee

    Franklin, Tennessee, 37067-5665

  • Velocity Clinical Research - Gaffney - PPDS

    Gaffney, South Carolina, 29340-4737

  • Clinical Research of Gastonia

    Gastonia, North Carolina, 28054-7481

  • Trialfinity Clinical Research Center

    Hamilton, New Jersey, 08619

  • ASHA Clinical Research - Hammond

    Hammond, Indiana, 46324

  • Greater Heights Memorial Pulmonary and Sleep

    Houston, Texas, 77008

  • Houston Pulmonary Medicine Associates, PA - Biopharma Informatic - PPDS

    Houston, Texas, 77089

  • Stern Research Partners, LLC

    Huntersville, North Carolina, 28078

  • Huntsville Research Institute LLC

    Huntsville, Texas, 77340

  • MultiSpecialty Clinical Research, Inc

    Johnson City, Tennessee, 37604

  • Advance Clinical Research

    Kettering, Ohio, 45439

  • Sierra Clinical Research

    Las Vegas, Nevada, 89106

  • Downtown LA Research Center Inc - ClinEdge

    Los Angeles, California, 90017

  • Monroe Biomedical Research -343 Venus St

    Monroe, North Carolina, 28112-4025

  • Horizon Family Medical Group - New Windsor Primary Care

    New Windsor, New York, 12553-7754

  • Lowcountry Lung and Critical Care PA

    North Charleston, South Carolina, 29406

  • Monroe Biomedical Research Charleston

    North Charleston, South Carolina, 29406

  • California Medical Research Associates, Inc.

    Northridge, California, 91324-6200

  • Florida Institute For Clinical Research LLC

    Orlando, Florida, 32825-4454

  • Ormond Beach Clinical Research

    Ormond Beach, Florida, 32174-8196

  • Elite Clinical Studies, LLC

    Phoenix, Arizona, 85018

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Clinical Research Institute, Inc - CRN

    Plymouth, Minnesota, 55441-2676

  • Progressive Medical Research

    Port Orange, Florida, 32127-5169

  • Clinical Research of Rock Hill

    Rock Hill, South Carolina, 29732

  • Velocity Clinical Research (Rockville - Maryland) - PPDS

    Rockville, Maryland, 20854-2960

  • Northern California Research Corp

    Sacramento, California, 95821-2640

  • Midwest Chest Consultants PC

    Saint Charles, Missouri, 63301

  • Element Research Group

    San Antonio, Texas, 78258

  • Carolina Research Center, Inc

    Shelby, North Carolina, 28150-3803

  • Sherman Clinical Research - 403 N. Highland Ave

    Sherman, Texas, 75092

  • Revive Research Institute, Inc

    Southfield, Michigan, 48075

  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303-4755

  • Velocity Clinical Research

    Spartanburg, South Carolina, 29303

  • Midwest Clinical Research LLC

    St Louis, Missouri, 63141-7051

  • The Clinical Research Center LLC - CRN

    St Louis, Missouri, 63141

  • Clinical Research of West Florida Inc - Tampa

    Tampa, Florida, 33606

  • Tucson Clinical Research Institute

    Tucson, Arizona, 85712

  • Velocity Clinical Research - Union - PPDS

    Union, South Carolina, 29379

  • Velocity Clinical Research - Valparaiso

    Valparaiso, Indiana, 46383

  • Tranquil Clinical Research

    Webster, Texas, 77598-4085

Other trials in United States

About this study

Official title: A Phase IIb, Randomized, Double-blind, Placebo- Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ensifentrine-glycopyrrolate Fixed-dose Combination at Two Dose Levels Compared to Glycopyrrolate or Ensifentrine Monotherapy in Subjects With COPD

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 participants with chronic obstructive pulmonary disease (COPD).

Read the detailed description

Enrolled participants will be expected to participate for approximately 7 weeks: 1 to 2 weeks for screening, 4 weeks of treatment, and 1 week of follow up. Participants will be randomized to one of 6 treatment arms: two fixed dose combinations of ensifentrine (3 mg) and glycopyrrolate (either 21.25 or 42.5 mcg), the 3 individual components as monotherapies, or placebo. All treatments will be administered twice a day via oral inhalation by a standard jet nebulizer. The primary objective of this study is to evaluate the bronchodilator effects of the fixed dose combinations compared to each of the individual components and to placebo.

Being tested
Ensifentrine 3 mg, Glycopyrrolate 21.25 mcg, Glycopyrrolate 42.5 mcg, Placebo
Keywords
Chronic Obstructive Pulmonary Disease, COPD, bronchodilator, ensifentrine-glycopyrrolate
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ensifentrine 3 mgDrug

    Administered by a standard jet nebulizer, twice daily for 28 consecutive days

  • Glycopyrrolate 21.25 mcgDrug

    Administered by a standard jet nebulizer, twice daily for 28 consecutive days

  • Glycopyrrolate 42.5 mcgDrug

    Administered by a standard jet nebulizer, twice daily for 28 consecutive days

  • PlaceboDrug

    Administered by a standard jet nebulizer, twice daily for 28 consecutive days

Study groups in NCT07016412
Study groupRoleWhat they receive
Treatment Arm A: Ensifentrine plus GlycopyrrolateExperimentalParticipants will receive ensifentrine 3 mg / glycopyrrolate 42.5 mcg twice a day for up to 28 days via oral inhalation by a standard jet nebulizer.
Receives: Drug: Ensifentrine 3 mg; Drug: Glycopyrrolate 42.5 mcg
Treatment Arm B: Ensifentrine plus GlycopyrrolateExperimentalParticipants will receive ensifentrine 3 mg / glycopyrrolate 21.25 mcg twice a day for up to 28 days via oral inhalation by a standard jet nebulizer.
Receives: Drug: Ensifentrine 3 mg; Drug: Glycopyrrolate 21.25 mcg
Treatment Arm C: GlycopyrrolateActive comparatorParticipants will receive glycopyrrolate monotherapy 42.5 mcg twice a day for up to 28 days via oral inhalation by a standard jet nebulizer.
Receives: Drug: Glycopyrrolate 42.5 mcg
Treatment Arm D: GlycopyrrolateActive comparatorParticipants will receive glycopyrrolate monotherapy 21.25 mcg twice a day for up to 28 days via oral inhalation by a standard jet nebulizer.
Receives: Drug: Glycopyrrolate 21.25 mcg
Treatment Arm E: EnsifentrineActive comparatorParticipants will receive ensifentrine monotherapy 3 mg twice a day for up to 28 days via oral inhalation by a standard jet nebulizer.
Receives: Drug: Ensifentrine 3 mg
Treatment Arm F: PlaceboPlacebo comparatorParticipants will receive placebo twice a day for up to 28 days via oral inhalation by a standard jet nebulizer.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Average Forced Expiry Volume in 1 Second (FEV1) Area Under the Curve Versus Time From Time 0 to 4 Hours (AUC0-4h)

    Spirometry will be performed to determine the FEV1. Change from baseline in average FEV1 area under the curve from 0 to 4 hours on Day 28 will be reported.

    Measured: Baseline and Day 28

Secondary outcomes (35)

  1. Change From Baseline in Peak FEV1 Measured Over 4 Hours Post-Dose

    Spirometry will be performed to determine the FEV1. Change from baseline in peak FEV1 over 4 hours following dosing on Day 28 will be reported.

    Measured: Baseline and Day 28

  2. Change From Baseline in Average FEV1 Area Under the Curve Versus Time From Time 0 to 12 Hours (AUC0-12h)

    Spirometry will be performed to determine the FEV1. Change from baseline in average FEV1 area under the curve from 0 to 12 hours on Day 28 will be reported.

    Measured: Baseline and Day 28

  3. Change From Baseline in Morning Trough FEV1 on Day 29

    Spirometry will be performed to determine the FEV1. Change from baseline in morning trough FEV1 measured on Day 29 will be reported.

    Measured: Baseline and Day 29

  4. Change From Baseline in Evening Trough FEV1 on Day 28

    Spirometry will be performed to determine the FEV1. Change from baseline in evening trough FEV1 measured on Day 28 will be reported.

    Measured: Baseline and Day 28

  5. Change From Baseline in Morning Trough FEV1 on Day 28

    Spirometry will be performed to determine the FEV1. Change from baseline in morning trough FEV1 measured on Day 28 will be reported.

    Measured: Baseline and Day 28

  6. Change From Baseline in Average FEV1 AUC0-4h Measured After First Dose on Day 14

    Spirometry will be performed to determine the FEV1. Change from baseline in average FEV1 area under the curve from 0 to 4 hours following the first dose on Day 14 will be reported.

    Measured: Baseline and Day 14

  7. Change From Baseline in Peak FEV1 Measured Over 4 Hours After First Dose on Day 14

    Spirometry will be performed to determine the FEV1. Change from baseline in peak FEV1 over 4 hours following the first dose on Day 14 will be reported.

    Measured: Baseline and Day 14

  8. Change From Baseline in Average FEV1 AUC0-4h Measured After First Dose on Day 1

    Spirometry will be performed to determine the FEV1. Change from baseline in average FEV1 area under the curve from 0 to 4 hours following the first dose on Day 1 will be reported.

    Measured: Baseline and Day 1

  9. Change from Baseline in Peak FEV1 Measured Over 4 Hours After First Dose on Day 1

    Spirometry will be performed to determine the FEV1. Change from baseline in peak FEV1 over 4 hours following the first dose on Day 1 will be reported.

    Measured: Baseline and Day 1

  10. Change in Symptoms of Dyspnea from Baseline as Measured by Transition Dyspnea Index (TDI) Score on Day 14

    The TDI measures the change in dyspnea symptom severity from the baseline as measured by the Baseline Dyspnea Index (BDI). It is based on three components, functional impairment, magnitude of task, and magnitude of effort, that evoke dyspnea in activities of daily living. The BDI score ranges from 0 (very severe impairment) to 4 (no impairment) for each domain and are summed to determine the BDI focal score (0-12). The TDI score ranges from -3 (major deterioration) to +3 (major improvement) for each domain. The sum of all domains yields the TDI focal score (-9 to +9). Change from baseline in TDI score on Day 14 will be reported.

    Measured: Baseline and Day 14

  11. Change in Symptoms of Dyspnea from Baseline as Measured by TDI Score on Day 28

    The TDI measures the change in dyspnea symptom severity from the baseline as measured by the BDI. It is based on three components, functional impairment, magnitude of task, and magnitude of effort, that evoke dyspnea in activities of daily living. The BDI score ranges from 0 (very severe impairment) to 4 (no impairment) for each domain and are summed to determine the BDI focal score (0-12). The TDI score ranges from -3 (major deterioration) to +3 (major improvement) for each domain. The sum of all domains yields the TDI focal score (-9 to +9). Change from baseline in TDI score on Day 28 will be reported.

    Measured: Baseline and Day 28

  12. Change From Baseline in Health-Related Quality of Life as Measured by Saint George's Respiratory Questionnaire (SGRQ) Total Score

    The SGRQ Patient Reported Outcome (PRO) measure is a 50- item questionnaire designed to assess health-related quality of life in patients with COPD in terms of symptoms, daily activity limitation, and psychosocial well-being. The total score ranges from 0 to 100, with lower scores indicating better health status. Change from baseline in health-related quality of life as assessed using SGRQ total score on Day 28 will be reported.

    Measured: Baseline and Day 28

  13. Number of Participants who Experience at Least one Treatment Emergent Adverse Event (TEAE)

    An AE is any untoward medical occurrence in a subject, temporally associated with the use of the study medication, whether or not considered related to the study medication. Number of participants who experience at least one TEAE will be reported.

    Measured: Up to approximately 5 weeks

  14. Number of Participants With Markedly Abnormal Changes in Hematology Parameters

    Number of participants with markedly abnormal changes in hematology parameters will be reported.

    Measured: Up to approximately Day 28

  15. Number of Participants With Markedly Abnormal Changes in Blood Chemistry Parameters

    Number of participants with markedly abnormal changes in blood chemistry parameters will be reported.

    Measured: Up to approximately Day 28

  16. Number of Participants With Markedly Abnormal Changes in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)

    Number of participants with markedly abnormal changes in QTcF measurements will be reported.

    Measured: Up to approximately Day 28

  17. Number of Participants With Markedly Abnormal Changes in Heart Rate

    Number of participants with markedly abnormal changes in heart rate will be reported.

    Measured: Up to approximately Day 28

  18. Number of Participants With Markedly Abnormal Changes in Blood Pressure

    Number of participants with markedly abnormal changes in blood pressure will be reported.

    Measured: Up to approximately Day 28

  19. Number of Participants With Markedly Abnormal Changes in Pulse Rate

    Number of participants with markedly abnormal changes in pulse rate will be reported.

    Measured: Up to approximately Day 28

  20. Area Under the Concentration-Time Curve from Time 0 to 12 Hours (AUC0-12hrs) of Ensifentrine

    Blood samples will be collected to determine the AUC0-12hrs of ensifentrine.

    Measured: Predose and at designated timepoints up to 12 hours postdose

  21. Maximum Plasma Concentration (Cmax) of Ensifentrine

    Blood samples will be collected to determine the Cmax of ensifentrine.

    Measured: Predose and at designated timepoints up to day 28 postdose

  22. Plasma Trough Concentration (Ctrough) of Ensifentrine

    Blood samples will be collected to determine the Ctrough of ensifentrine.

    Measured: Day 28

  23. Average Plasma Concentrations (Cavg) of Ensifentrine

    Blood samples will be collected to determine the Cavg of ensifentrine.

    Measured: Day 28

  24. Time to Maximum Plasma Concentration (Tmax) of Ensifentrine

    Blood samples will be collected to determine the Tmax of ensifentrine.

    Measured: Predose and at designated timepoints up to day 28 postdose

  25. Apparent Clearance (CL/F) of Ensifentrine

    Blood samples will be collected to determine the CL/F of ensifentrine.

    Measured: Day 28

  26. Accumulation Ratio Cmax (ARCmax) of Ensifentrine

    Blood samples will be collected to determine the ARCmax of ensifentrine.

    Measured: Predose and at designated timepoints up to day 28 postdose

  27. Accumulation Ratio AUC (ARAUCs) of Ensifentrine

    Blood Samples Will be Collected to Determine the ARAUC of Ensifentrine.

    Measured: Predose and at designated timepoints up to day 28 postdose

  28. Area Under the Concentration-Time Curve from Time 0 to 12 Hours (AUC0-12hrs) of Glycopyrronium

    Blood samples will be collected to determine the AUC0-12hrs of glycopyrronium.

    Measured: Predose and at designated timepoints up to 12 hours postdose

  29. Maximum Plasma Concentration (Cmax) of Glycopyrronium

    Blood samples will be collected to determine the Cmax of glycopyrronium.

    Measured: Predose and at designated timepoints up to day 28 postdose

  30. Plasma Trough Concentration (Ctrough) of Glycopyrronium

    Blood samples will be collected to determine the Ctrough of glycopyrronium.

    Measured: Day 28

  31. Average Plasma Concentrations (Cavg) of Glycopyrronium

    Blood samples will be collected to determine the Cavg of glycopyrronium.

    Measured: Day 28

  32. Time to Maximum Plasma Concentration (Tmax) of Glycopyrronium

    Blood samples will be collected to determine the Tmax of glycopyrronium.

    Measured: Predose and at designated timepoints up to day 28 postdose

  33. Apparent Clearance (CL/F) of Glycopyrronium

    Blood samples will be collected to determine the CL/F of glycopyrronium.

    Measured: Day 28

  34. Accumulation Ratio Cmax (ARCmax) of Glycopyrronium

    Blood samples will be collected to determine the ARCmax of glycopyrronium.

    Measured: Predose and at designated timepoints up to day 28 postdose

  35. Accumulation Ratio AUC (ARAUCs) of Glycopyrronium

    Blood Samples Will be Collected to Determine the ARAUC of glycopyrronium.

    Measured: Predose and at designated timepoints up to day 28 postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2025
  2. Study start31 Jul 2025
  3. Primary completion17 Aug 2026
  4. Study completion17 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
497 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07016412
Sponsor's protocol ID
RPL554-CO-212
Status last verified
Sep 2026
First submitted
3 Jun 2025
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ensifentrine 3 mg, Glycopyrrolate 21.25 mcg and Glycopyrrolate 42.5 mcg in people with Chronic Obstructive Pulmonary Disease, run by Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA at 57 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Average Forced Expiry Volume in 1 Second (FEV1) Area Under the Curve Versus Time From Time 0 to 4 Hours (AUC0-4h) (time frame: Baseline and Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07016412.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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