A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Extension Study to Evaluate the Long-term Efficacy and Safety of Tozorakimab in Participants with Chronic Obstructive Pulmonary Disease (COPD) with a History of Exacerbations (PROSPERO)
This research is a big study looking into a new medication called Tozorakimab for people living with Chronic Obstructive Pulmonary Disease (COPD). Specifically, it's for those who have had flare-ups of their COPD in the past. The main goal is to find out if Tozorakimab can help reduce how often these severe flare-ups happen and to check if it's safe to use over a long period. Some participants will receive Tozorakimab, while others will receive a dummy medicine (placebo) to fairly compare the effects. Researchers will also look at other things like how long it takes for a first flare-up to occur and how safe the medicine is overall.
At a glance
What is this study about?
This study is about a new medicine, called Tozorakimab, for people who have Chronic Obstructive Pulmonary Disease (COPD). COPD causes breathing difficulties, and sometimes people experience sudden worsening of their symptoms, known as flare-ups or exacerbations, which can be very serious. This research is a 'Phase III' study, which means it's one of the final steps in testing a new medicine before it might become more widely available. It involves a large number of people and is designed to confirm whether the medicine works well and is safe over a longer period.
The main idea behind this study is to see if Tozorakimab can help reduce the number of severe COPD flare-ups people experience, especially those who have had flare-ups before. To get clear results, some participants will receive Tozorakimab, while others will be given a 'placebo', which looks like the real medicine but contains no active drug. This allows the researchers to fairly compare the effects of the new treatment against not having it.
Throughout the study, the research team will closely monitor participants. They'll be looking at how often severe flare-ups happen, how quickly they occur, and also how safe the Tozorakimab medicine is. They'll also check how the medicine behaves in the body and if the body creates any reactions to it. The aim is to gather strong evidence to understand if Tozorakimab could be a good long-term treatment option for people with COPD to help manage their condition better.
Key takeaways
- Tests a new medicine, Tozorakimab, for severe COPD flare-ups.
- Compares Tozorakimab to a dummy medicine (placebo).
- Aims to see if the medicine reduces flare-ups long-term.
- Also checks the safety of Tozorakimab over time.
- For adults aged 18 and over with COPD and previous flare-ups.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women are welcome to participate. The study is specifically looking for people who have been diagnosed with Chronic Obstructive Pulmonary Disease (COPD).
An important part of who can join is whether you have experienced COPD flare-ups in the past. The study is particularly interested in people with a history of these flare-ups, as this is who the new medicine is designed to help.
There might be other specific health requirements or conditions that would mean you can or cannot take part, but these details would be discussed with you by the study team.
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 a diagnosis of Chronic Obstructive Pulmonary Disease (COPD)?
- Have you experienced COPD flare-ups (exacerbations) in the past?
- Are you willing to attend regular clinic visits over a long period?
What does participation involve?
If you decide to join this study, it will involve regular visits to a clinic over a long period. You will either receive the new medicine, Tozorakimab, or a dummy medicine called a placebo. Neither you nor your study doctor will know which one you are receiving – this is called 'double-blind' and helps ensure fair results.
During your visits, you'll have various health checks, which might include breathing tests, blood samples, and physical examinations. These help the doctors understand how your COPD is doing and how the medicine is affecting you. You'll also be asked about your symptoms and any side effects you might experience.
The study is designed to look at the effects of the medicine long-term, so it will involve taking the study medicine regularly over an extended period. There will also be follow-up appointments after you stop taking the medicine to ensure your well-being. The exact number of visits and the total length of your involvement will be clearly explained by the study team.
Potential risks and benefits
Locations (17)
- —UnverifiedSweden
- —UnverifiedRomania
- —UnverifiedSpain
- —UnverifiedItaly
- —UnverifiedGermany
- —UnverifiedPoland
- —UnverifiedFinland
- —UnverifiedCzechia
- —UnverifiedHungary
- —UnverifiedBulgaria
- —UnverifiedDenmark
- —UnverifiedBelgium
Common questions
What is COPD?
COPD stands for Chronic Obstructive Pulmonary Disease, a lung condition that makes it hard to breathe. It often causes coughing, wheezing, and shortness of breath.
What is a 'severe COPD exacerbation'?
This is when your COPD symptoms suddenly get much worse, often needing urgent medical attention, a hospital visit, or even hospitalisation.
What is Tozorakimab?
Tozorakimab is the name of the new medicine being tested in this study. Researchers hope it can help people with COPD.
What does 'placebo-controlled' mean?
It means some people get the actual medicine and others get a dummy medicine (a placebo). This helps researchers see if the new medicine really works better than no treatment.
Will I know if I'm getting the real medicine or the placebo?
No, this is a 'double-blind' study, meaning neither you nor your study doctor will know if you're receiving Tozorakimab or the placebo. This helps keep the study fair.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.