Pulmonary Disease, Chronic Obstructive study: Ensifentrine
Official title 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)
ClinicalTrials.gov ID: NCT07874815
What this study is testing
What is Ensifentrine?
An investigational inhaled medicine being studied as a potential treatment to prevent COPD exacerbations and improve lung function. It is designed to inhibit phosphodiesterase‑3 and phosphodiesterase‑4 enzymes, which may help relax airway muscles and reduce inflammation.
Also referred to as MK-5884, RPL554.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether ensifentrine (a medicine) can prevent moderate and severe COPD flare‑ups and improve breathing and quality of life compared with a pretend treatment.
- Who it's for
- You may be able to join if you are an adult with COPD who has had moderate or severe flare‑ups before and are already on standard care.
- What's involved
- You would take a dose of ensifentrine or a pretend pill while staying on your usual COPD medicines. You will go to the clinic for check‑ups and breathing tests.
- Time commitment
- The study lasts about a year with regular clinic visits every few months.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- 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...
- 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...
- Has post-bronchodilator forced expiratory volume 1 (FEV1) ≥25% and \<70% of Predicted Normal Value
You likely can't join if
- 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...
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Hialeah Gardens, Florida, United States
- Loxahatchee Groves, Florida, United States
- Valparaiso, Indiana, United States
- The Bronx, New York, United States
- Charleston, South Carolina, United States
- Chattanooga, Tennessee, United States
- Victoria, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Hialeah Gardens, Florida, United States; Loxahatchee Groves, Florida, United States; Valparaiso, Indiana, United States; The Bronx, New York, United States; Charleston, South Carolina, United States; Chattanooga, Tennessee, United States and 1 more location. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.