Ensifentrine (MK-5884) Study for the Prevention of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in Adults With a History of Moderate or Severe Exacerbations While Receiving Standard of Care (SOC) (MK-5884-031/RPL554/ENHANCE-3)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ensifentrine (MK-5884) Versus Placebo for the Prevention of COPD Exacerbations in Adults With a History of Moderate or Severe Exacerbations While Receiving Standard of Care (ENHANCE-3)
Who can join
Ages 40 to 80 · All sexes
Full eligibility criteria
Inclusion Criteria: Inclusion Criteria include but are not limited to: * Has a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) that was made ≥12 months prior to randomization * Has been on the stable treatment with the same standard of care (SOC) with long-acting muscarinic antagonist (LAMA)/long-acting beta-2 agonist (LABA)/inhaled corticosteroid (ICS) or LAMA/LABA (if ICS is not appropriate), for at least 2 months prior to Screening * Has a documented history of ≥1 moderate or severe COPD exacerbation while on standard of care (SOC) within 1 year of Screening * Is a current or former cigarette smoker with a history of cigarette smoking ≥10 packyears at Screening (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, cigar, and/or e-cigarette/vape use cannot be used to calculate pack-year history. * Has post-bronchodilator forced expiratory volume 1 (FEV1) ≥25% and \<70% of Predicted Normal Value Exclusion Criteria: Exclusion criteria include but are not limited to: * Has a history of intubation for respiratory failure within 1 year of Screening * Is receiving long-term oxygen therapy defined as \>15 hours per day * Uses chronic bilevel positive airway pressure for treatment of respiratory condition unless for treatment of sleep apnea at a stable pressure for at least 3 months * Is currently using or has used a biologic therapy (e.g., dupilumab, mepolizumab, or tozorakimab) within 6 months prior to Screening Visit * Has history of or current malignancy of any organ system, treated or untreated within the past 5 years, except for localized basal or squamous cell carcinoma of the skin.
About the study
The purpose of this study is to evaluate the efficacy and safety of ensifentrine (MK-5884) compared with placebo for the prevention of moderate and severe COPD exacerbation in adults with COPD and a history of exacerbations while receiving SOC treatment. The study will also evaluate the efficacy of ensifentrine compared with placebo in improving lung function, improving health related quality of life, and preventing severe exacerbations.
What is being tested
- Ensifentrine (drug)
- Placebo (other)
- Standard of Care (SOC) (drug)
Sponsor: Merck Sharp & Dohme LLC · Participants: 2,136 · Started: Nov 2, 2026
Contact the study team
- Toll Free Number · Phone: 1-888-577-8839
Official record on ClinicalTrials.gov — NCT07874815
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.