ENLIGHTEN 2: A Phase III, Randomized, Blinded, Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis (CRS) in Adults
The ENLIGHTEN 2 study is a research project for adults who suffer from long-lasting sinus inflammation, known as chronic rhinosinusitis (CRS). This condition can cause bothersome symptoms like a blocked nose, facial pain, and discharge. The main goal of this study is to test a new treatment called LYR-210 to see how well it works and if it's safe. Participants will be compared to others receiving a different treatment, Dexamethasone. Researchers will carefully check if LYR-210 helps improve the main sinus symptoms, such as nasal blockage, facial pain, and discharge, over a period of 24 weeks. They are particularly interested in how participants without nasal polyps respond to the treatment.
At a glance
What is this study about?
This research study, named ENLIGHTEN 2, is investigating a new way to treat chronic rhinosinusitis (CRS) in adults. CRS is a long-term condition where the sinuses become inflamed, leading to symptoms such as nasal blockage, facial pain or pressure, and a runny or dripping nose. These symptoms can be very disruptive to daily life. The study aims to find out if a new treatment, called LYR-210, can effectively reduce these symptoms and improve the quality of life for people living with CRS.
In this study, participants will be given either the new LYR-210 treatment or another medication called Dexamethasone. The study is "blinded," which means that neither you nor your study doctor will know which treatment you are receiving. This is a common practice in medical research to ensure the results are as fair and unbiased as possible. Researchers will carefully monitor your symptoms over 24 weeks to see how your condition changes.
The main thing researchers will be looking at is how much your key sinus symptoms – blocked nose, facial pain, and discharge – improve over the 24-week period, especially for those participants who don't have nasal polyps. They will also look at how much other symptoms improve, changes in your overall sinus health as measured by special questionnaires, and if you need any extra 'rescue' treatment during the study. They will also use CT scans to look at changes inside your sinuses.
Key takeaways
- The ENLIGHTEN 2 study is testing a new treatment (LYR-210) for chronic sinus problems in adults.
- It aims to see if LYR-210 improves symptoms like blocked nose and facial pain over 24 weeks.
- Participation involves clinic visits, symptom assessments, and taking study medication.
- You won't know if you're getting LYR-210 or a standard treatment (Dexamethasone).
- The study lasts about 24 weeks, with potential follow-up calls.
- You can stop participating at any time if you change your mind.
Who may be eligible?
This study is looking for adults aged 18 and over who have been diagnosed with chronic rhinosinusitis (CRS). This means you have had ongoing sinus problems for a significant amount of time.
Both men and women are welcome to participate. The study is specifically focused on adults, so individuals under the age of 18 would not be able to join.
There might be other specific health requirements or conditions that could determine if you are a good fit for the study. These could include whether you have nasal polyps or if you are taking certain other medications. Before joining, the study team will ask you some questions and do a health check to make sure the study is a good and safe option for you.
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 18 years old or older?
- Have you been diagnosed with chronic rhinosinusitis (ongoing sinus problems)?
- Are you able to attend appointments regularly over approximately 24 weeks?
- Are you comfortable with the idea of not knowing which study treatment you are receiving?
What does participation involve?
If you decide to take part in this study, you'll have several visits to the clinic over a period of about 24 weeks. During these visits, the study team will assess your health, ask you about your symptoms, and you'll receive the study medication. This might involve different types of assessments, such as filling out questionnaires about your symptoms and potentially having some scans to look at your sinuses. The exact number of visits and tests will be explained in detail before you agree to join. You'll be given either the LYR-210 treatment or the Dexamethasone treatment, but you won't know which one, as it's a 'blinded' study. After the initial 24 weeks, there might be some follow-up appointments to check in on your health.
Potential risks and benefits
Locations (5)
- —UnverifiedHungary
- —UnverifiedBelgium
- —UnverifiedGermany
- —UnverifiedBulgaria
- —UnverifiedPoland
Common questions
What is Chronic Rhinosinusitis (CRS)?
It's a long-lasting inflammation of your sinuses, causing symptoms like a blocked nose, facial pain, and discharge for many weeks or months.
What is LYR-210?
LYR-210 is a new treatment being tested in this study to see if it can help improve symptoms of chronic rhinosinusitis.
Will I know which treatment I'm getting?
No, this is a 'blinded' study, so neither you nor your doctor will know if you're receiving LYR-210 or the comparison treatment, Dexamethasone.
How long will the study last for me?
Your active participation in the study, including receiving treatment and having assessments, will last for about 24 weeks.
What if the treatment doesn't work for me?
The study team will monitor your progress closely. If your symptoms worsen or the treatment doesn't seem to be working, they will discuss options with you, and you can withdraw from the study at any point.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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