Effect of Ensifentrine on Sputum Markers of Inflammation in COPD
Recruiting · 3 sites across 3 states
Always free
Study care at no cost to you
For your time and travel
Many studies pay you back
Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
Ask for your language
Your choice
Voluntary — you can stop anytime
What is this study?
This is a randomized, double-blind, placebo-controlled, two-period cross-over study of nebulized ensifentrine (3 mg) or placebo administered BID for two 8-week Treatment Periods. All participants with receive both ensifentrine and placebo during participation.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
This is a randomized, double-blind, placebo-controlled, two-period cross-over study of nebulized ensifentrine (3 mg) or placebo administered BID for two 8-week Treatment Periods. All participants with receive both ensifentrine and placebo during participation. There are 7 in-clinic visits over a total duration of up to 24 weeks participation.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •You are male or female and 40 to 80 years old.
- •You have a history of cigarette smoking of at least 10 pack-years and have COPD diagnosed by breathing guideline standards, with symptoms that fit COPD.
- •Your breathing test shows COPD severity: your pre- and post-albuterol/salbutamol FEV1/FVC ratio is less than 0.70, and your post-albuterol FEV1 is at least 30% and at most 80% of predicted.
- •You regularly use COPD breathing medicines (bronchodilators) for at least 4 weeks before screening, and you agree to use the study’s COPD maintenance therapy once daily through the last study visit.
- •You can use a jet nebulizer, do the breathing tests (spirometry) properly, and produce sputum samples during the induced sputum procedure.
🚫 You may not be able to join if…
- •You have a lung disease other than COPD, such as current asthma, diffuse interstitial lung diseases, cystic fibrosis, or clinically significant bronchiectasis (as judged by the investigator).
- •You were hospitalized for COPD, pneumonia, or COVID-19 in the 12 weeks before screening, or you test positive for active COVID-19 infection at screening.
- •You have certain serious liver problems (ALT 2× or more the upper limit of normal; or alkaline phosphatase and/or bilirubin more than 1.5× the upper limit of normal, with stated exceptions).
- •You have HIV infection or another immunodeficiency.
- •You have certain heart rhythm/QT problems (corrected QT interval by Fridericia method >450 ms for males or >480 ms for females) or a history of significant heart rhythm problems, or you have known trouble producing sputum with sputum induction, or you are allergic to ensifentrine or study medicines.
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 40–80
- ✓Have COPD (chronic lung disease)
- !Some conditions may not be a fit: Asthma
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
Has this treatment been tested before?
Yes. This treatment has already been through earlier human studies for safety before reaching this stage.
What you need to know before you apply
What is this study testing?+
This is a randomized, double-blind, placebo-controlled, two-period cross-over study of nebulized ensifentrine (3 mg) or placebo administered BID for two 8-week Treatment Periods. All participants with receive both ensifentrine and placebo during participation.
Is it safe? Who makes sure of that?+
This is a mid-stage study (Phase 2), looking at safety and whether the treatment works. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
The study treatment and study-related visits are provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.
Source: ClinicalTrials.gov · NCT05270525 · Locations: Alabama · Michigan · Pennsylvania