A Multicenter, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab 100 mg in Patients with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) with a History of Frequent COPD Exacerbations and Elevated Peripheral Blood Eosinophils (RESOLUTE)
This study is looking into a new treatment called benralizumab for people in the UK who have Chronic Obstructive Pulmonary Disease (COPD). Specifically, it's for those with moderate to very severe COPD who often experience sudden worsening of their symptoms, known as flare-ups, and have higher-than-normal levels of a particular white blood cell called eosinophils in their blood. The main goal is to find out if benralizumab can help reduce how often these flare-ups happen and if it is a safe medicine to use. Participants will either receive the new medicine or a dummy medicine (placebo) to compare the effects, and neither they nor their doctors will know which one they are getting.
At a glance
What is this study about?
Imagine you have Chronic Obstructive Pulmonary Disease (COPD), which can make it hard to breathe. Sometimes, your breathing problems can get much worse suddenly, and you might need extra medication or even a hospital visit. These are called 'flare-ups' or 'exacerbations'. This study is investigating a new medicine, benralizumab, to see if it can help people with moderate to very severe COPD who experience these frequent flare-ups. It's particularly for those who also have a specific type of white blood cell, called eosinophils, in higher numbers in their blood.
The main purpose of this study is to discover if benralizumab can reduce how often these flare-ups happen. A flare-up in this study means your COPD symptoms getting worse and needing treatment like steroids or antibiotics, or even a hospital stay. We also want to understand if the medicine is safe and doesn't cause too many unwanted side effects. Researchers will be comparing benralizumab to a 'dummy' medicine (placebo) to ensure any improvements seen are genuinely due to the study medicine and not just other factors.
By carefully studying these things, the hope is to find a new way to help people with COPD manage their condition better, reduce their flare-ups, and potentially improve their quality of life. This type of study, called a Phase 3 study, is a big step towards getting new medicines approved for general use if they prove to be effective and safe.
Key takeaways
- This study is for adults with moderate to very severe COPD.
- It's for people who have frequent COPD flare-ups and high blood eosinophil levels.
- It's testing a new medicine called benralizumab to reduce flare-ups.
- Participants will receive either benralizumab or a dummy medicine.
- The main goals are to check if the medicine works and if it's safe.
Who may be eligible?
This study is looking for adults who are at least 18 years old. Both men and women are welcome to take part.
To be considered for this study, you must have been diagnosed with moderate to very severe COPD. A key part of qualifying is also having a history of frequent COPD flare-ups, meaning your breathing has worsened often in the past, requiring extra medical attention.
Another important requirement is that blood tests need to show you have higher levels of a specific type of white blood cell called eosinophils. This helps researchers understand if benralizumab works best for people with this particular characteristic.
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 at least 18 years old?
- Have you been diagnosed with moderate to very severe COPD?
- Do you get frequent COPD flare-ups that need extra treatment?
- Have your doctor or blood tests shown you have high levels of eosinophils?
What does participation involve?
If you join this study, you'll be given either the study medicine, benralizumab, or a 'dummy' medicine (placebo). You won't know which one you're getting, and neither will your study doctor. Both are given as an injection under the skin using a prefilled syringe.
During the study, you'll have regular visits to the clinic for health checks, blood tests, and to assess your breathing. These visits will help the study team monitor your COPD, check for any flare-ups, and see how you're feeling overall. They will also keep track of any side effects you might experience. The total duration of your involvement in the study, including all treatments and follow-up appointments, will be explained to you in detail by the study team.
Potential risks and benefits
Locations (13)
- —UnverifiedNetherlands
- —UnverifiedSpain
- —UnverifiedSweden
- —UnverifiedDenmark
- —UnverifiedItaly
- —UnverifiedHungary
- —UnverifiedBelgium
- —UnverifiedAustria
- —UnverifiedPoland
- —UnverifiedGermany
- —UnverifiedCzechia
- —UnverifiedGreece
Common questions
What is COPD?
COPD stands for Chronic Obstructive Pulmonary Disease. It's a group of lung conditions that cause breathing difficulties, like emphysema and chronic bronchitis.
What does 'flare-up' mean?
A COPD flare-up means your usual breathing problems suddenly get worse, often needing extra treatments like steroids or antibiotics, or a hospital visit.
What are eosinophils?
Eosinophils are a type of white blood cell. Higher levels in your blood can sometimes indicate certain types of inflammation, like in some forms of COPD.
What is a 'placebo'?
A placebo is a 'dummy' treatment that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the real medicine's effects.
Why is this study important?
This study is important because it could lead to a new treatment option for people with COPD who frequently suffer from flare-ups, potentially improving their quality of life.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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