Study to Evaluate Long-term Effectiveness and Safety, Patient Characteristics and Subjective Patient-reported Outcomes of Dupilumab in Patients With Chronic Obstructive Pulmonary Disease (COPD) Under Real-world Conditions
This study is about understanding how a medicine called dupilumab helps people with Chronic Obstructive Pulmonary Disease (COPD) in real-world situations. It's not a typical trial where you're given a new treatment; instead, doctors are already prescribing dupilumab as part of their usual care. Researchers will collect information over two years to see if the medicine helps improve patients' health, daily life, and whether it's safe. They'll be looking at things like how patients feel and how their COPD symptoms change. This helps us learn more about dupilumab's long-term effects for people with COPD outside of a strict research setting.
At a glance
What is this study about?
This study aims to discover more about a medicine called dupilumab and how it affects people living with a lung condition called Chronic Obstructive Pulmonary Disease (COPD). COPD makes it hard to breathe, and doctors are trying to find better ways to manage it. This particular study isn't about testing if dupilumab works, as doctors are already prescribing it when they think it's appropriate for their patients.
Instead, this research is about observing people who are already being treated with dupilumab in their daily lives. Over two years, the study will gather information on how their health-related quality of life changes – that's how well they're feeling and how much their condition affects their day-to-day activities. It will also look at how effective the treatment seems to be for different people and if there are any safety concerns.
By collecting data from real patients in a real-world setting, rather than a highly controlled environment, researchers hope to get a clearer picture of dupilumab's long-term effects. This helps doctors and patients understand better how the medicine works when used as part of regular care.
Key takeaways
- This study observes real patients taking dupilumab for COPD.
- It aims to understand long-term effects on health and quality of life.
- Participation lasts for two years.
- You won't receive dupilumab specifically for the study; your doctor will prescribe it.
- Data is collected from your routine medical appointments.
Who may be eligible?
To join this study, you must be an adult who has been told you have COPD. Your COPD should still be difficult to control even though you're already taking several common medications for it (like LAMA/LABA/ICS, or LAMA/LABA if ICS isn't suitable for you) and you must have higher levels of certain blood cells called eosinophils.
A key part of joining is that your doctor must have recently decided to start you on dupilumab treatment for your COPD, based on official guidance for the medicine. You can't join if you're already taking dupilumab for a while or if your doctor hasn't chosen this treatment for you.
There are also reasons you couldn't take part. For example, if you've been in another similar study recently, or if you've been in hospital for a COPD flare-up in the last four weeks. Also, if your doctor feels that another health issue or your ability to fill in questionnaires would make it hard for you to participate or might affect the study results, you might not be able to join.
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 an adult (18 or older)?
- Have you been diagnosed with COPD?
- Is your COPD still difficult to manage, even with your current inhalers (LAMA/LABA/ICS or LAMA/LABA)?
- Do your blood tests show you have high eosinophils?
- Has your doctor recently decided to start you on dupilumab for your COPD?
- Have you NOT been in hospital for a COPD flare-up in the last month?
What does participation involve?
If you decide to participate, you won't be given dupilumab specifically for the study; your doctor will prescribe it as part of your normal care because they think it's the right treatment for you. Throughout the study, which will last for 24 months (two years), your doctor will simply collect information from your usual clinic visits and check-ups. This information will include details about your health, how you're feeling, and how your COPD is responding to the treatment. You might be asked to fill out questionnaires about your health and quality of life. There won't be any extra visits or procedures beyond what your doctor would normally do to manage your COPD.
Potential risks and benefits
Locations (18)
- Investigational Site Number: DE18Verified postcodeAuerbach, Germany· Recruiting
- Investigational Site Number: DE21Verified postcodeAugsburg, Germany· Recruiting
- Investigational Site Number: DE13Verified postcodeBad Homburg, Germany· Recruiting
- Investigational Site Number: DE19Verified postcodeBerlin, Germany· Recruiting
- Investigational Site Number: DE02Verified postcodeBerlin, Germany· Recruiting
- Investigational Site Number: DE29Verified postcodeBurgwedel, Germany· Recruiting
- Investigational Site Number: DE01Verified postcodeDarmstadt, Germany· Recruiting
- Investigational Site Number: DE09Verified postcodeErkelenz, Germany· Recruiting
- Investigational Site Number: DE06Verified postcodeFlensburg, Germany· Recruiting
- Investigational Site Number: DE08Verified postcodeFürstenwalde, Germany· Recruiting
- Investigational Site Number: DE03Verified postcodeHamburg, Germany· Recruiting
- Investigational Site Number: DE04Verified postcodeHamburg, Germany· Recruiting
Common questions
What is COPD?
COPD stands for Chronic Obstructive Pulmonary Disease. It's a common lung condition that makes it difficult to breathe, often getting worse over time.
What is dupilumab?
Dupilumab is a medicine used to treat certain conditions, and doctors are now using it for some people with severe COPD.
Will I get dupilumab if I join this study?
No, you will only join this study if your doctor has already decided to start you on dupilumab as part of your normal treatment, completely separate from the study.
How long will the study last?
The study will follow your progress for 24 months, which is two years.
What does 'real-world setting' mean?
It means the study is observing how the medicine works in typical doctor's offices and hospitals, as part of everyday patient care, rather than highly controlled research environments.
How to find out more
Trial Transparency email recommended (Toll free for US & Canada)
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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