2136 Participants NeededMy employer runs this trial

Ensifentrine for Chronic Obstructive Pulmonary Disease

(ENHANCE-3 Trial)

Recruiting at 6 trial locations
TF
Overseen ByToll Free Number
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Merck Sharp & Dohme LLC
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for adults with COPD who have had at least one moderate or severe flare-up in the past year while on stable standard treatment. Participants must be current or former cigarette smokers (at least 10 pack-years) and have moderately reduced lung function.

Inclusion Criteria

My lung function is between 25% and 70% of normal after using a bronchodilator.
I have smoked at least 10 pack-years of cigarettes in my life.
I have been on the same inhaler treatment for at least 2 months.
See 2 more

What Are the Treatments Tested in This Trial?

Interventions

  • Ensifentrine

Trial Overview

The study compares a new inhaled drug called ensifentrine to a placebo, both given alongside usual COPD treatments, to see if it can reduce flare-ups and improve breathing and quality of life. Participants are randomly assigned to each group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: EnsifentrineExperimental Treatment2 Interventions
Group II: PlaceboPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University