Recruiting
Phase 3

Ensifentrine

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07874815

Conditions

Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Ensifentrine

Placebo

Standard of Care (SOC)

Study Details

Brief summary:

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study ID

NCT07874815

Start date

Nov 2, 2026

Status verified date

Nov, 2026

Completion date

Apr 29, 2029

Anticipated

Primary completion date

Apr 29, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

2136 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ensifentrine

Participants, who meet the criteria of being on standard of care (SOC) background treatment receive ensifentrine twice a day (bid) by oral inhalation via a standard jet nebulizer for up to 52 weeks.

placebo comparator: Placebo

Participants, who meet the criteria of being on SOC background treatment receive placebo bid by oral inhalation via a standard jet nebulizer for up to 52 weeks.

Interventions

Ensifentrine

Delivered twice daily by oral inhalation via a standard jet nebulizer

Placebo

Placebo matched to ensifentrine delivered twice daily by oral inhalation via a standard jet nebulizer

Standard of Care (SOC)

Background treatment of LAMA/LABA/ICS or LAMA/LABA (if ICS is not appropriate) administered per product approved label delivered by oral inhalation as part of standard of care

Primary outcome measure

  • Annualized Rate of Adjudicated Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations [ Time Frame: Up to 52 Weeks ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

Family First Medical Research Center ( Site 4458)

Recruiting

Hialeah Gardens, Florida, United States, 33016

Contacts

Study Coordinator

786-665-9374

Advanced Pulmonary Research Institute ( Site 4427)

Recruiting

Loxahatchee Groves, Florida, United States, 33470

Contacts

Study Coordinator

561-603-6688

Velocity Clinical Research ( Site 4464)

Recruiting

Valparaiso, Indiana, United States, 46383

Contacts

Study Coordinator

219-464-8302

CHEAR Center LLC ( Site 4407)

Recruiting

The Bronx, New York, United States, 10455

Contacts

Study Coordinator

347-270-1111

Lowcountry Lung & Critical Care, PA ( Site 4413)

Recruiting

Charleston, South Carolina, United States, 29406

Contacts

Study Coordinator

843-572-8545

M3 Wake Research, Inc. ( Site 4440)

Recruiting

Chattanooga, Tennessee, United States, 37421

Contacts

Study Coordinator

423-698-4584

Victoria Clinical Research Group ( Site 4430)

Recruiting

Victoria, Texas, United States, 77901

Contacts

Study Coordinator

361-210-7869

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Nov 6, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-07. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-11-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.