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Chronic Obstructive Pulmonary DiseasePhase 2NCT07132983

A Phase II Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Single Inhaled Doses of Ensifentrine-glycopyrrolate Fixed Dose Combination, Ensifentrine, and Glycopyrrolate in Subjects With Chronic Obstructive Pulmonary Disease

A Phase 2 study testing Ensifentrine 3 mg, Glycopyrrolate 42.5 mcg and Ensifentrine 1.5 mg in people with Chronic Obstructive Pulmonary Disease, run by Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA at 4 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 pharmacokinetics (PK), pharmacodynamics (PD) and safety of ensifentrine and glycopyrrolate fixed dose (FDC) product, the individual components of the FDC (ensifentrine and glycopyrrolate, each in the FDC formulation), ensifentrine 1.5 mg in the FDC formulation and ensifentrine 3 mg in the… 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 42.5 mcg and Ensifentrine 1.5 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
4 sitesUnited States
Study dates
6 Oct 2025to 28 Nov 2025
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 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 and not to donate eggs for the purpose of reproduction from screening throughout the study and for at least 30 days post-study
  • Current or former cigarette smokers with a history of cigarette smoking ≥ 10 pack years as of signing the ICF [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 the ICF. Smoking cessation programs are permitted during the study
  • Subjects 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
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  • 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 ≥ 40 % and ≤ 80% of predicted normal
  • A posterior-anterior chest x-ray (CXR) during the Screening Period or within 12 months prior to signing the 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
  • Capable of withholding from short-acting bronchodilators for at least 4 hours if using albuterol and for at least 6 hours if using ipratropium prior to pre-dose of blinded study medication spirometry testing
  • Anatomical features of peripheral veins that allow the ability to draw sufficient blood volume for all study samples
  • Capable of using the study supplied 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 (e.g., asthma, tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases, sleep apnea (unless controlled with stable continuous positive airway pressure 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 therapies for a COPD exacerbation (e.g., oral, intravenous, or intramuscular glucocorticoids; antibiotics; theophylline; 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)
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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 subject from safely completing the required tests or the study, or is likely to result in disease progression that would require withdrawal of the subject
  • 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, glycopyrrolate, any excipients/components of the study medications, anticholinergic agents, or sympathomimetic amines
  • History of or current malignancy of any organ system, treated or untreated within the 5 years prior to signing the ICF, except for localized basal or squamous cell carcinoma of the skin
  • Other significant psychiatric disease that would likely result in the subject not being able to complete the study, in the opinion of the Investigator
  • Findings on physical examination that the Investigator considers to be clinically significant during the Screening Period
  • Prior or current use of Ohtuvayre (ensifentrine)
  • Previous lung resection or lung reduction surgery within 1-year of randomization
  • Patients with a recent history of a COPD exacerbation requiring treatment or hospitalization for an exacerbation are excluded, as are patients requiring supplemental oxygen (defined as oxygen therapy prescribed for the treatment of COPD). As needed oxygen 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 to randomization, lack of full recovery from surgery as of 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
  • Any other abnormal hematology, biochemistry, or viral serology assessed during the Screening Period deemed by the Investigator to be clinically significant
  • Alanine aminotransferase (ALT) ≥ 2 × upper limit of normal (ULN), aspartate aminotransferase (AST) ≥ 2 × ULN, alkaline phosphatase and/or total bilirubin > 1.5 × ULN (subjects 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 randomization, whichever is longer, and/or participation in a study treatment-free follow-up phase of a clinical study within 30 days prior to randomization
  • 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 randomization
  • 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

4 sites in 1 country.

United States4 sites

  • Clinical Research of West Florida Inc - Clearwater

    Clearwater, Florida, 33765-2616

  • Midwest Chest Consultants PC

    Saint Charles, Missouri, 63301

  • Velocity Clinical Research - Spartanburg - PPDS

    Spartanburg, South Carolina, 29303-4225

  • Clinical Research of West Florida Inc - Tampa

    Tampa, Florida, 33606-1246

Other trials in United States

About this study

Official title: A Phase II, Randomized, Double-Blind, Cross-Over Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Single Inhaled Doses of Ensifentrine-Glycopyrrolate Fixed Dose Combination, Ensifentrine, and Glycopyrrolate in Subjects With Chronic Obstructive Pulmonary Disease

This study will assess the pharmacokinetics (PK), pharmacodynamics (PD) and safety of ensifentrine and glycopyrrolate fixed dose (FDC) product, the individual components of the FDC (ensifentrine and glycopyrrolate, each in the FDC formulation), ensifentrine 1.5 mg in the FDC formulation and ensifentrine 3 mg in the marketed formulation each administered via a 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, 5 single doses of study medication with each dose followed by an approximately 7-day washout period (total of 5 weeks), and 1 week of follow-up. Participants will be randomized to receive all the treatments in different sequences.

The primary objective of the study is to evaluate the pharmacokinetics of the fixed-dose combination of ensifentrine and glycopyrrolate compared to each drug alone and to ensifentrine in a different formulation.

Being tested
Ensifentrine 3 mg, Glycopyrrolate 42.5 mcg, Ensifentrine 1.5 mg, Ensifentrine 3 mg (marketed formulation)
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

    Single dose, administered by oral inhalation using a standard jet nebulizer

  • Glycopyrrolate 42.5 mcgDrug

    Single dose, administered by oral inhalation using a standard jet nebulizer

  • Ensifentrine 1.5 mgDrug

    Single dose, administered by oral inhalation using a standard jet nebulizer

  • Ensifentrine 3 mg (marketed formulation)Drug

    Single dose, administered by oral inhalation using a standard jet nebulizer

Study groups in NCT07132983
Study groupRoleWhat they receive
Treatment A: Ensifentrine plus GlycopyrrolateExperimental(fixed-dose combination formulation) Subjects will receive a single dose of study medication in each treatment period followed by a 7 to 9-day washout period before receiving the next treatment in the sequence they were assigned to
Receives: Drug: Ensifentrine 3 mg; Drug: Glycopyrrolate 42.5 mcg
Treatment B: Ensifentrine monotherapyExperimental(fixed-dose combination formulation) Subjects will receive a single dose of study medication in each treatment period followed by a 7 to 9-day washout period before receiving the next treatment in the sequence they were assigned to
Receives: Drug: Ensifentrine 3 mg
Treatment C: Glycopyrrolate monotherapyExperimental(fixed-dose combination formulation) Subjects will receive a single dose of study medication in each treatment period followed by a 7 to 9-day washout period before receiving the next treatment in the sequence they were assigned to
Receives: Drug: Glycopyrrolate 42.5 mcg
Treatment D: Ensifentrine monotherapyExperimental(fixed-dose combination formulation) Subjects will receive a single dose of study medication in each treatment period followed by a 7 to 9-day washout period before receiving the next treatment in the sequence they were assigned to
Receives: Drug: Ensifentrine 1.5 mg
Treatment E: Ensifentrine monotherapy (marketed formulation)ExperimentalSubjects will receive a single dose of study medication in each treatment period followed by a 7 to 9-day washout period before receiving the next treatment in the sequence they were assigned to
Receives: Drug: Ensifentrine 3 mg (marketed formulation)

What is being measured

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

  1. Ensifentrine single dose area under the curve from time 0 to time t (AUC0-t)

    Measured: Day 1 through 48 hours after each dose of study medication

  2. Ensifentrine single dose area under the curve from time 0 extrapolated to infinity (AUC0-inf)

    Measured: Day 1 through 48 hours after each dose of study medication

  3. Ensifentrine single dose maximum observed concentration (Cmax)

    Measured: Day 1 through 48 hours after each dose of study medication

  4. Glycopyrronium single dose AUC0-t

    Measured: Day 1 through 48 hours after each dose of study medication

  5. Glycopyrronium single dose AUC0-inf

    Measured: Day 1 through 48 hours after each dose of study medication

  6. Glycopyrronium single dose Cmax

    Measured: Day 1 through 48 hours after each dose of study medication

  7. Change from average baseline in forced expiratory volume over 1 second (FEV1) to FEV1 area under the curve versus time from time 0 to 12 hours (AUC0-12h)

    Measured: Baseline through 12 hours after each dose of study medication

  8. Change from average baseline FEV1 to average FEV1 area under the curve versus time from time 0 to 4 hours (AUC0-4h)

    Measured: Baseline through 4 hours after each dose of study medication

  9. Change from average baseline FEV1 to peak FEV1 measured over 4 hours post-dose

    Measured: Baseline through 4 hours after each dose of study medication

  10. Change from average baseline FEV1 to 12-hour post-dose (evening trough) FEV1

    Measured: Baseline through 12 hours after each dose of study medication

  11. Incidence of treatment emergent adverse events (TEAEs)

    Measured: From first dose through the end of study (approximately 6 weeks)

  12. Change from baseline in QTcF as measured by 12-lead ECG

    Measured: Baseline and visits 2, 5, 8, 11, and 14

  13. Change from baseline in blood pressure

    Measured: Baseline through end of study (approximately 6 weeks)

  14. Change from baseline in heart rate

    Measured: Baseline through end of study (approximately 6 weeks)

Timeline

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

  1. First posted20 Aug 2025
  2. Study start6 Oct 2025
  3. Primary completion28 Nov 2025
  4. Study completion28 Nov 2025

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
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07132983
Sponsor's protocol ID
RPL554-CO-210
Status last verified
Dec 2025
First submitted
11 Aug 2025
Last updated
8 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ensifentrine 3 mg, Glycopyrrolate 42.5 mcg and Ensifentrine 1.5 mg in people with Chronic Obstructive Pulmonary Disease, run by Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA at 4 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 15 inclusion and 25 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 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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. 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?

Ensifentrine single dose area under the curve from time 0 to time t (AUC0-t) (time frame: Day 1 through 48 hours after each dose of study medication). The study lists 14 primary outcomes in all. 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 NCT07132983.

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 8 Jan 2026.

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