A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled 28-week Phase III Efficacy and Safety Study of Tezepelumab in Reducing Oral Corticosteroid Use in Adults with Oral Corticosteroid Dependent Asthma (SUNRISE)
This research study is looking at a new medication called Tezepelumab. It's for adults with a type of severe asthma where they need to take steroid tablets regularly to manage their condition. The main goal is to find out if Tezepelumab can help people lower the amount of steroid tablets they take each day without their asthma getting worse. Researchers will also check how safe Tezepelumab is and if it helps with other asthma symptoms like breathing and how often asthma attacks happen. This information will help doctors understand if Tezepelumab could be a good treatment option for this specific group of asthma patients.
At a glance
What is this study about?
This study, called SUNRISE, is testing a new medicine called Tezepelumab (also known as Tezspire) for adults who have severe asthma. You might be in this group if your doctor has told you that you need to take steroid tablets by mouth, like prednisolone, to keep your asthma under control. While these steroids can be very helpful, taking them for a long time can sometimes lead to side effects. This study is trying to see if Tezepelumab can help people reduce the amount of these steroid tablets they need to take, or even stop them completely, while still keeping their asthma well-managed.
To figure this out, some people in the study will receive the new medicine, Tezepelumab, and others will receive a placebo. A placebo looks just like the real medicine but contains no active ingredients. This helps researchers compare the two groups fairly. Neither you nor your study doctor will know which one you are receiving – this is called a 'double-blind' study. The study looks at how much people can reduce their steroid dose over 28 weeks (about 7 months) while making sure their asthma doesn't get worse.
Beyond reducing steroids, the study will also look at other important things. This includes how much your breathing improves, how often you have asthma attacks, and how your asthma affects your daily life and quality of sleep. Researchers will also be checking the safety of Tezepelumab during this time.
Key takeaways
- This study tests a new medicine for severe asthma.
- It aims to help people reduce their steroid tablet use.
- Participants will receive either the new medicine or a placebo.
- The study measures how much steroid dose can be reduced and checks asthma control.
- It also checks for improvements in breathing and asthma attacks.
- The study lasts for about 7 months.
Who may be eligible?
This study is looking for adults who are 18 years old or older. Both men and women can take part.
You might be suitable for this study if you have 'oral corticosteroid dependent asthma.' This means you have severe asthma that requires you to take steroid tablets by mouth regularly to control your symptoms.
However, there will be other specific health requirements and medical history checks to make sure the study is right and safe for you. These will be discussed in detail by the study team. If you think you match the age and steroid-dependent asthma criteria, you can explore it further.
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?
- Do you have severe asthma that requires you to take steroid tablets by mouth regularly?
- Are you able to attend regular clinic visits for about 7 months?
- Are you comfortable with the idea of potentially receiving a placebo?
What does participation involve?
If you decide to join this study, you will be in it for about 28 weeks (around 7 months). During this time, you will receive either the study medicine, Tezepelumab, or a placebo, which looks identical but has no active drug. Both are given as an injection in a pre-filled syringe.
You will have several visits to the clinic where doctors and nurses will monitor your health and asthma. They will regularly check how much steroid medicine you are taking and if your asthma is staying under control. You will also have tests like breathing checks and blood tests. You might be asked to fill out questionnaires about your asthma symptoms and how they affect your daily life. The study team will carefully guide you on how to reduce your steroid dose step-by-step, if appropriate for you, and monitor you closely throughout the study.
Potential risks and benefits
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Common questions
What is 'oral corticosteroid dependent asthma'?
It means you have severe asthma that needs you to take steroid tablets by mouth regularly to keep your symptoms under control.
What is Tezepelumab (Tezspire)?
It's a new medicine being tested for people with severe asthma. It's given as an injection.
What is a 'placebo'?
A placebo looks like the study medicine but contains no active drug. It helps researchers compare the real medicine's effects.
Will I know if I'm getting the medicine or the placebo?
No, this is a 'double-blind' study, meaning neither you nor your study doctor will know what you are receiving.
How long will I be in the study?
The study lasts for 28 weeks, which is about 7 months.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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