Ensa?fentrine to help prevent COPD flare-ups in adults on standard care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial compares ensifentrine (MK-5884) to placebo when added to patients' usual COPD therapy. Eligible adults have COPD with a history of exacerbations and are on stable SOC including LAMA/LABA/ICS or LAMA/LABA. The study will evaluate whether ensifentrine reduces exacerbations, and may also look at lung function and health-related quality of life. Primary focus is safety and efficacy in preventing moderate to severe COPD flare-ups while maintaining standard care. Participants will continue their SOC throughout the trial at compatible sites in Florida and Indiana.

Why it matters

Who can join: the full rules

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.

Where it's running

• Family First Medical Research Center ( Site 4458)
  Hialeah Gardens, Florida, United States Recruiting
• Advanced Pulmonary Research Institute ( Site 4427)
  Loxahatchee Groves, Florida, United States Recruiting
• Velocity Clinical Research ( Site 4464)
  Valparaiso, Indiana, United States Recruiting
• CHEAR Center LLC ( Site 4407)
  The Bronx, New York, United States Recruiting
• Lowcountry Lung & Critical Care, PA ( Site 4413)
  Charleston, South Carolina, United States Recruiting
• M3 Wake Research, Inc. ( Site 4440)
  Chattanooga, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.