NCT07874815Not yet recruitingPhase 3
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)
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 2136 (estimated)
- First submitted
- 30 Sept 2026
- Start date
- 23 Oct 2026
- Primary completion date
- 29 Apr 2029
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- COPD
- NCT number
- NCT07874815
- EU CT number
- 2026-526255-61-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 2136
- From 23 Oct 2026 to the primary completion date, 29 Apr 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Is receiving long-term oxygen therapy defined as \>15 hours per day
- Is currently using or has used a biologic therapy (e.g., dupilumab, mepolizumab, or tozorakimab) within 6 months prior to Screening Visit
Other illness
- Has a history of intubation for respiratory failure within 1 year of Screening
- 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
- 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.
Who the study is looking for
- 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
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.