RecruitingPhase 2

A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD

United States480 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 range40 Years – 80 Years

SexALL

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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
✕. 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

What they're measuring

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 Days 1, 14, 28, and 29

Trial details

NCT IDNCT07016412

SponsorVerona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08-05

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