Study of the effect of non-adherence to standard asthma preventer treatment (inhaled steroids) on response to biologic treatment (mepolizumab) in people with severe asthma
Severe asthma can cause frightening attacks that standard inhalers cannot fully control. In these cases, doctors often prescribe advanced treatments called biologics, such as mepolizumab, alongside regular daily preventer inhalers. However, mepolizumab does not work well for everyone. Researchers in Birmingham want to see if missing daily steroid inhalers is one reason why some people do not get better. This is an observational study, meaning no one is given new medicines or experimental treatments. Instead, researchers will look back at the medical and prescription records of adults who received mepolizumab between 2017 and 2023. By understanding how often patients collected their inhalers and how their asthma responded, the study team hopes to find better ways to help people take their daily medicines, ensuring they get the best possible benefit from their severe asthma treatments.
At a glance
What is this study about?
Asthma causes swelling and narrowing of the airways, making it hard to breathe. For most people, a daily steroid preventer inhaler keeps these symptoms under control. But for some with severe asthma, standard inhalers are not quite enough to stop frequent, scary flare-ups. In recent years, newer targeted medicines called biologics have transformed care. One of these is mepolizumab, an injection that calms down specific immune cells that trigger severe lung inflammation.
Even though mepolizumab helps many people breathe easier, it does not work for everyone. Doctors suspect that one major reason could be related to everyday inhalers. It is easy to forget or skip daily preventer sprays, especially when starting a new treatment. However, mepolizumab is designed to work alongside regular steroid inhalers, not replace them. If daily inhalers are missed, the biologic injection might not be able to do its job properly.
Researchers at the Birmingham Regional Severe Asthma Service are running this study to see if there is a clear link between missed inhalers and poor responses to mepolizumab. They also want to understand the common challenges that lead to missed doses. By identifying these patterns, doctors and nurses can provide better support in clinics, helping people keep their asthma well-controlled and avoid hospital visits.
Key takeaways
- The study explores whether missing daily steroid inhalers stops mepolizumab from working well.
- It is an observational study using existing health records, with no new medicines or extra visits.
- Open to adults treated for severe asthma in Birmingham between June 2017 and June 2023.
- There are no physical risks, and taking part will not change your daily routine or routine care.
- Findings could help doctors better support people with severe asthma in the future.
Who may be eligible?
This study is open to adults aged 18 and older who have been diagnosed with severe eosinophilic asthma. To take part, you must have started mepolizumab treatment through the Birmingham Regional Severe Asthma Service (BRSAS) between June 2017 and June 2023.
You also need to be willing and able to give your informed written consent for the research team to look at your medical files. Both men and women of any age up to 100 years can participate.
Because this study relies entirely on reviewing existing medical information, the only reason someone would be excluded is if they choose not to give their consent for researchers to view their records.
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.
- I am aged 18 or older.
- I have been diagnosed with severe eosinophilic asthma.
- I received mepolizumab treatment through the Birmingham Regional Severe Asthma Service between June 2017 and June 2023.
- I am happy to give written consent for researchers to review my hospital and GP records.
What does participation involve?
Taking part in this study is very straightforward because it is observational. This means you do not need to take any new medicines, change your current routine, or test experimental drugs. You will not have to attend extra hospital visits, undergo blood tests, or take time off work.
If you agree to take part, you will sign a consent form. The research team will then look at information already stored in your hospital records, the local severe asthma registry, and your GP prescription history. They will check how often you picked up your steroid inhalers and how your asthma behaved while on mepolizumab. The study runs from May 2022 to August 2024, but your active involvement simply involves giving permission for your records to be reviewed.
Potential risks and benefits
Locations (1)
- Birmingham Regional Severe Asthma NetworkCity onlyBirmingham, England
Common questions
Will I need to take a new or untested medication?
No. This is an observational study that only looks at medical records. You will continue to take your normal prescribed asthma medicines.
Do I have to visit the hospital more often?
No. There are no extra clinic visits, blood tests, or breathing tests required to take part.
How does the study team get my prescription information?
With your written permission, the researchers will check your hospital notes and GP records to see when your regular inhalers were dispensed.
Will my personal details be kept private?
Yes. All health data is handled strictly according to NHS data protection and confidentiality laws. Your name will not appear in any published findings.
What happens if I change my mind later?
You can withdraw your consent at any point without needing to provide a reason. Your ongoing NHS asthma care will not be affected in any way.
How to find out more
Adel Mansur
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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