A Phase II Study of Ensifentrine in Non-Cystic Fibrosis Bronchiectasis
This study is looking at a new inhaled medicine called ensifentrine for people who have non-cystic fibrosis bronchiectasis, a long-term lung condition. We want to find out if this medicine, delivered through a nebulizer twice a day, can help reduce breathing flare-ups, ease symptoms, and improve overall quality of life. Some participants will receive the active medicine, while others will receive a placebo (a dummy medicine with no active ingredients). This helps us understand the true effects of ensifentrine. The study will last for at least 24 weeks, comparing the new medicine to standard care. Your participation could help us learn more about treating this condition.
At a glance
What is this study about?
You're looking at information about a research study for a lung condition called non-cystic fibrosis bronchiectasis. This condition means your airways are wider than they should be, making it harder to clear mucus and leading to infections and breathing difficulties. This study is testing a new medicine called ensifentrine to see if it can help people manage their condition better.
The main aim is to find out if taking ensifentrine regularly, using a device called a nebulizer, can reduce flare-ups (when your symptoms suddenly get worse and you might need antibiotics). We also want to see if it improves how you feel day-to-day, your breathing, and your overall quality of life. This is a "Phase II" study, which means it's an important step in checking if the medicine is safe and if it works as expected before it can be studied in larger groups of people.
To make sure the results are fair and accurate, some people in the study will receive ensifentrine, while others will receive a placebo (a dummy medicine that looks and feels the same but has no active drug). Neither you nor the study team will know who is getting which, and you'll continue to receive your usual medical care alongside the study treatment. This combination helps us understand exactly what impact ensifentrine might have.
Key takeaways
- Tests a new inhaled medicine (ensifentrine) for non-cystic fibrosis bronchiectasis.
- Aims to reduce lung flare-ups and improve breathing.
- Involves using a nebulizer twice daily for at least 24 weeks.
- Some participants get the real medicine, some get a dummy medicine (placebo).
- Regular clinic visits for monitoring and tests.
- Could help improve understanding and treatment of bronchiectasis.
Who may be eligible?
To join this study, you need to be an adult between 18 and 80 years old with a diagnosis of non-cystic fibrosis bronchiectasis. Your diagnosis needs to be confirmed by a chest CT scan, and you should have experienced at least one lung flare-up requiring antibiotics or antivirals in the past year. You also need to produce mucus regularly and be able to provide a sample during your initial visit.
There are also some important rules about contraception for both men and women to ensure safety during the study and for 30 days afterwards. You'll need to be able to use the nebulizer correctly and perform some breathing tests. The doctors will check all these things to make sure the study is right for you, and that you're right for the study.
However, you cannot take part if you have other main lung conditions like COPD or asthma, or if your bronchiectasis is caused by cystic fibrosis or certain immune system problems. Current smokers cannot participate. These rules are in place to ensure the study focuses on the specific type of bronchiectasis we're investigating and to keep all participants safe.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 80 years old?
- Do you have non-cystic fibrosis bronchiectasis confirmed by a scan?
- Have you had a lung infection requiring antibiotics/antivirals in the last year?
- Do you regularly produce mucus?
- Are you a non-smoker?
- Are you able to use a nebulizer and do breathing tests?
What does participation involve?
If you decide to take part, you'll be given either the study medicine, ensifentrine, or a placebo (a dummy medicine). You won't know which one you're receiving, and neither will the study team. Both will be taken using a nebulizer, which turns the medicine into a fine mist for you to breathe in, twice a day.
The treatment period will last for at least 24 weeks, but could be up to 52 weeks. Over this time, you'll have regular visits to the clinic so the team can monitor your health, check your symptoms, perform breathing tests, and see how you're responding to the treatment. You'll also provide mucus samples. These visits are important for gathering all the necessary information about the medicine's effects. Your overall participation in the study, including follow-up, will be determined by the study's progress and when all participants have completed at least 24 weeks of treatment.
Potential risks and benefits
Locations (51)
- Kirklin Clinic of UAB HospitalVerified postcodeBirmingham, United States· Recruiting
- So Cal Institute for Respiratory Diseases, Inc.Verified postcodeLos Angeles, United States· Recruiting
- University of California Davis Medical CenterVerified postcodeSacramento, United States· Recruiting
- National Jewish Health Main CampusVerified postcodeDenver, United States· Recruiting
- MedStar Georgetown University HospitalVerified postcodeWashington D.C., United States· Recruiting
- University of MiamiVerified postcodeMiami, United States· Recruiting
- Emory University at Saint Joseph Pulmonary ClinicVerified postcodeAtlanta, United States· Recruiting
- Augusta UniversityVerified postcodeAugusta, United States· Recruiting
- ASHA Clinical ResearchVerified postcodeHammond, United States· Recruiting
- University of IowaVerified postcodeIowa City, United States· Recruiting
- University of Kansas Medical Center-Kansas CityVerified postcodeKansas City, United States· Recruiting
- Massachusetts General Hospital- 55 Fruit StVerified postcodeBoston, United States· Recruiting
Common questions
What is a nebulizer?
A nebulizer is a machine that turns liquid medicine into a fine mist that you breathe in through a mask or mouthpiece, helping the medicine get deep into your lungs.
What is a placebo?
A placebo is a 'dummy' medicine that looks exactly like the real medicine but contains no active drug. It helps researchers understand if the new medicine is truly working better than no treatment at all.
What does 'double-blind' mean?
Double-blind means that neither you nor the doctors treating you will know whether you are receiving the real medicine or the placebo. This helps prevent any bias in the study results.
How long will I be in the study?
You will be taking the study medicine for at least 24 weeks, and potentially up to 52 weeks, depending on the study's overall timeline.
Will I still receive my usual treatment?
Yes, you will continue to receive your standard medical care for bronchiectasis while participating in this study.
How to find out more
Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway Toll Free Number
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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