Active not recruitingOBSERVATIONAL

Use of Dupilumab in Asthma in Real-world Setting

This study focuses on people in the UK who take dupilumab (Dupixent) for their severe asthma. Dupilumab is a biological medicine that helps control asthma by targeting specific inflammation. The main goal is to understand who these patients are, how their asthma is managed with dupilumab in a real-world setting, and what healthcare resources they use. Researchers also want to see how the use of other asthma medications, like steroids, changes after starting dupilumab. Finally, they will look at how long people continue to use dupilumab. This helps doctors and patients better understand the real-life effects of this treatment.

At a glance

Status

Active not recruiting

Sponsor

Hospices Civils de Lyon

Enrolment target

35,000

Start

02 Jan 2025

Estimated completion

31 Dec 2026

Asthma Acute

What is this study about?

Asthma can be a challenging condition, and for some people, it's very severe. The main aim of asthma treatment is to help you breathe better, stop severe asthma attacks, improve your lung function, and allow you to live a more normal life without too many side effects from your medicines. Dupilumab (brand name Dupixent) is a special type of medicine called a monoclonal antibody. It works by blocking two specific proteins (IL-4 and IL-13) in your body that are involved in the inflammation often seen in severe asthma.

Dupilumab has been approved for use in the UK for adults and teenagers (aged 12 and over) who have severe asthma. This is usually when your asthma isn't well controlled even with high doses of standard asthma inhalers and other treatments. To qualify for dupilumab, you would typically have signs of a specific type of inflammation, like higher levels of certain cells in your blood (eosinophils) or a high level of a gas called nitric oxide in your breath.

This study isn't a traditional clinical trial where people are given a new medicine to test. Instead, it's called a "real-world setting" study. This means researchers are looking at information from people who are *already* using dupilumab for severe asthma in their daily lives. The study aims to understand important things like who is getting this treatment, what other healthcare they need, and how their use of other asthma medicines changes after starting dupilumab. They also want to see how consistently people use dupilumab over time. This kind of information is really valuable because it shows how the medicine works for a wide range of patients in everyday situations, not just in tightly controlled research settings.

Key takeaways

The study investigates how dupilumab is used for severe asthma in everyday healthcare.
It aims to understand patient characteristics, healthcare use, and steroid reliance.
Data collected is from routine medical records, not from new patient visits.
Participation involves anonymised data, meaning your identity is protected.
Results will help improve understanding and management of severe asthma.

Who may be eligible?

This study is looking at information from people who have already been prescribed dupilumab for their severe asthma and have received at least one reimbursement for it between November 2020 and December 2023.

To be included, the researchers need to see evidence that your doctor has confirmed you have asthma. This can be shown by whether you have received reimbursement for asthma inhalers (like steroids, or combined steroid and long-acting bronchodilator inhalers) around the time you started dupilumab. Another way to show you have asthma is if you've been registered with a long-term condition for asthma, or if you've been admitted to hospital for asthma within 12 months before or during your treatment with dupilumab.

The study is interested in both adults and young people aged 12 and older. There aren't any specific exclusion criteria mentioned, so if you fit the inclusion criteria, your anonymised data might be part of the study.

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.

Have you been prescribed dupilumab for severe asthma?
Did you receive at least one reimbursement for dupilumab between November 2020 and December 2023?
Have you been diagnosed with asthma by a doctor (e.g., through inhaler prescriptions or hospital admissions)?
Are you aged 12 years or older?

Answer every question to see your result.

What does participation involve?

As this is a 'real-world' study, you wouldn't typically be called to make extra visits, undergo specific assessments, or take part in new treatments. Instead, researchers will be looking at existing, anonymised healthcare records related to your use of dupilumab for severe asthma. This means your participation would be indirect, through the information already collected as part of your routine medical care and medicine reimbursements. There is no specific duration mentioned for individual participation, as it looks at data collected over a period when people used dupilumab.

Potential risks and benefits

Since this study uses information from existing medical records, there are no direct medical risks to you as a participant. Your identity is protected through anonymisation, meaning the researchers won't know who you are personally. The potential benefit is that the findings will help doctors and healthcare systems better understand dupilumab's real-world effectiveness and how to best manage severe asthma patients. You always have the right to discuss with your healthcare provider if you have concerns about your medical data being used for research, even if anonymised.

Locations (1)

Hospices Civils de Lyon
Verified postcode
Lyon, France

Common questions

What is dupilumab (Dupixent) for?

It's a biological medicine used for severe asthma, as well as some other conditions like severe eczema, when other treatments haven't worked well enough.

Will I have to do anything if my data is included?

No, this study uses existing, anonymised information. You won't have to make any extra visits or change your routine medical care.

What does 'real-world setting' mean?

It means the study looks at how a medicine works for people in their everyday lives, outside of very strict research conditions, using data from regular medical practice.

Will the study know who I am?

No, all the information used in the study is anonymised, meaning your personal details are removed so researchers cannot identify you.

What is the study hoping to find out?

It wants to understand who uses dupilumab, how it impacts their asthma management, their use of other medicines, and how long they continue with the treatment in daily practice.