A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tozorakimab in Participants with Symptomatic Chronic Obstructive Pulmonary Disease (COPD) with a History of COPD Exacerbations (MIRANDA)
This research study is looking at a new medicine called tozorakimab for people who have chronic obstructive pulmonary disease, or COPD. People with COPD often experience sudden worsening of their symptoms, known as flare-ups or exacerbations. This study wants to find out if tozorakimab can help reduce how often these flare-ups happen and how severe they are. Participants will be randomly given either the new medicine or a dummy medicine (placebo) alongside their usual treatments. The study is particularly interested in people who used to smoke and will compare the new medicine to the dummy medicine while monitoring participants closely to ensure their safety and track how their COPD symptoms change over time.
At a glance
What is this study about?
This study is a medical research project focused on a lung condition called Chronic Obstructive Pulmonary Disease, more commonly known as COPD. People with COPD often have difficulty breathing and can experience periods where their symptoms suddenly get much worse; these are called 'exacerbations' or 'flare-ups'. These flare-ups can be very serious and sometimes require a visit to the hospital.
The main aim of this study is to test a new medicine called tozorakimab. We want to see if this medicine can help reduce how often people with COPD have these flare-ups and how serious they are. The study will mainly look at people who used to smoke, as smoking is a major cause of COPD. It will compare the new medicine to a 'placebo', which looks exactly like the new medicine but contains no active drug. This helps us understand if any improvements are genuinely due to tozorakimab.
Participants will be looked after carefully throughout the study. We'll be checking many things, including how their breathing changes, their quality of life, and any side effects from the treatment. The findings from this study will help doctors understand if tozorakimab could be a helpful new treatment option for people living with COPD.
Key takeaways
- This study is testing a new medicine for COPD flare-ups.
- It aims to see if the medicine can reduce how often and how severe flare-ups are.
- Some people will get the new medicine, others a dummy medicine.
- Participants will have regular check-ups and continue their usual COPD care.
- Your safety and well-being are a top priority throughout the study.
- You can always change your mind and leave the study at any point.
Who may be eligible?
To join this study, you need to be at least 18 years old. Both men and women can take part. A key requirement is that you must have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) and have experienced flare-ups (exacerbations) of your COPD in the past.
You also need to be experiencing symptoms from your COPD. For example, you might have shortness of breath, coughing, or wheezing. The study is particularly looking for people who used to smoke, and in some cases, people who currently smoke might also be able to join.
There will be other specific health checks and medical history questions to ensure the study is safe and suitable for you. Your study doctor or nurse will go through all the details to make sure you tick all the boxes for joining.
- Are you 18 years old or older?
- Do you have a diagnosis of COPD?
- Have you experienced COPD flare-ups in the past?
- Are you currently experiencing symptoms from your COPD?
- Are you able to attend regular study appointments?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you'll be assigned by chance to either receive the new medicine, tozorakimab, or a 'dummy' medicine (placebo). Neither you nor your study doctor will know which one you are receiving. You will also continue to use your current inhalers, such as Salbutamol, as prescribed by your doctor.
You will need to attend regular appointments at the study clinic. These visits will involve health checks, breathing tests, questionnaires about your symptoms and well-being, and blood tests. This helps the study team keep track of your health, how your COPD is doing, and if the treatment is having any effects.
The study involves taking the medicine over a long period, and there will be follow-up appointments even after you stop taking the study medicine to make sure you're doing well. The full duration of your participation in the study from start to finish, including all visits and follow-ups, will be explained in detail by the study team.
Potential risks and benefits
Locations (12)
- —Greece
- —Denmark
- —Netherlands
- —Poland
- —Belgium
- —France
- —Hungary
- —Spain
- —Germany
- —Italy
- —Ireland
- —Bulgaria
Common questions
What is COPD?
COPD stands for Chronic Obstructive Pulmonary Disease. It's a common lung disease that makes it hard to breathe, often causing coughing, wheezing, and shortness of breath.
What is a 'flare-up' or 'exacerbation'?
A COPD flare-up is when your breathing problems and other symptoms suddenly get much worse than usual. It can be serious and may need extra treatment.
What does 'placebo' mean?
A placebo is a 'dummy' medicine. It looks exactly like the real study medicine but doesn't contain any active drug. It helps researchers see if the real medicine actually works.
Will I still use my regular COPD medicines?
Yes, you will continue to use your other prescribed COPD medicines, like your inhalers, as recommended by your doctor, alongside the study medicine or placebo.
Is this new medicine safe?
All new medicines are carefully tested for safety. While we can't guarantee there won't be any side effects, the study will closely monitor your health to check for any issues.
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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