A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects Wit… (NCT07016412) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD
United States1,119 participantsStarted 2025-07-31
Plain-language 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 subjects 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 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
. FEV1/forced vital capacity (FVC) ratio of \< 0.70 AND
. FEV1 ≥ 30 % and ≤ 70% 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, or
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.
1This trial is testing a fixed-dose combination of ensifentrine and glycopyrrolate — two bronchodilators working together — and it's in Phase IIb, which means researchers are still figuring out the right doses; given that, what is currently known about the safety profile of combining these two drugs, and what risks should I be aware of?
2The trial is no longer actively enrolling new participants — does that mean there's any possibility of joining at this stage, or should we focus on finding other options right now?
3The main thing this trial is measuring is how much lung function improves over a 4-hour window after taking the medication, as shown by FEV1 testing; how does that kind of short-term lung function measurement translate into what I might actually feel day-to-day living with COPD?
4Since this is still a dose-ranging study — meaning the optimal dose hasn't been confirmed yet — how does that uncertainty compare to what's already established with my current or standard COPD treatments, and would you recommend I try proven therapies first?
5What would my participation actually involve in terms of clinic visits, breathing tests, and time commitments, and given where I am in managing my COPD right now, do you think a trial at this stage of research would be a reasonable path to consider?
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
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)
Timeframe: Baseline and Day 28
Trial details
NCT IDNCT07016412
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