A Phase II Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Single Inhaled D… (NCT07132983) | Clinical Trial Compass
CompletedPhase 2
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
United States33 participantsStarted 2025-10-06
Plain-language 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 marketed formulation each administered via a standard jet nebulizer, in adult participants with chronic obstructive pulmonary disease (COPD).
Who can participate
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. FEV1/forced vital capacity (FVC) ratio of \< 0.70 AND
. FEV1 ≥ 40 % and ≤ 80% of predicted normal
Exclusion criteria
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ensifentrine single dose area under the curve from time 0 to time t (AUC0-t)
Timeframe: 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)
Timeframe: Day 1 through 48 hours after each dose of study medication
3
Ensifentrine single dose maximum observed concentration (Cmax)
Timeframe: Day 1 through 48 hours after each dose of study medication
4
Glycopyrronium single dose AUC0-t
Timeframe: Day 1 through 48 hours after each dose of study medication
5
Glycopyrronium single dose AUC0-inf
Timeframe: Day 1 through 48 hours after each dose of study medication
6
Glycopyrronium single dose Cmax
Timeframe: 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)
Trial details
NCT IDNCT07132983
SponsorVerona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA
. 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
Timeframe: 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)
Timeframe: 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
Timeframe: Baseline through 4 hours after each dose of study medication
10
Change from average baseline FEV1 to 12-hour post-dose (evening trough) FEV1
Timeframe: Baseline through 12 hours after each dose of study medication
11
Incidence of treatment emergent adverse events (TEAEs)
Timeframe: From first dose through the end of study (approximately 6 weeks)
12
Change from baseline in QTcF as measured by 12-lead ECG
Timeframe: Baseline and visits 2, 5, 8, 11, and 14
13
Change from baseline in blood pressure
Timeframe: Baseline through end of study (approximately 6 weeks)
14
Change from baseline in heart rate
Timeframe: Baseline through end of study (approximately 6 weeks)