Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof Christopher Brightling
+44 116 250 2704
abc-3tr@leicester.ac.uk


Miss Bonnie Millar
+44 (0)116 252 2893
abc-3tr@leicester.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

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Be Part of Research - Trial Details - Biomarkers of asthma remission after dupilumab treatment

Biomarkers of asthma remission after dupilumab treatment

Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Severe asthma


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Asthma affects over 350 million people in the world. Approximately 5-10% of people with asthma have severe disease. Asthma is a lung disease associated with inflammation (swelling) of the airways. Certain proteins made by the body, called interleukins, can make this inflammation worse. One of these interleukin proteins is called interleukin- 4Rα (IL4Rα). Interleukin-4Rα appears to play an important role in asthma. It plays a role by helping white blood cells (called eosinophils) stay alive. Eosinophils are involved in the inflammation of the airways. Dupilumab is a medicine that blocks the effect of Interleukin-4Rα on eosinophils (and therefore reduces inflammation). It is given as an injection under the skin and may help reduce inflammation in the airways of people with asthma. Previous research studies in people with severe asthma have shown an improvement in asthma control in those who received dupilumab, and it is now approved for the treatment of severe asthma in the UK. Research studies have shown that people who received dupilumab experienced about half as many asthma exacerbations (severe episodes of asthma or attacks) as those given placebo (dummy) injections. In addition, it also improved their lung function and asthma control. This research study will observe all participants having dupilumab injections as part of their normal clinical care. This will help to understand what might be causing the high levels of disease control, including the absence of symptoms and exacerbations. By doing this, it is hoped that information will be obtained to help improve asthma treatment in the future. The study team will investigate the effect of dupilumab on all aspects of asthma such as changes in quality of life, symptoms, inflammation and breathing tests.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

31 Aug 2023 31 May 2025

Every participant taking part in the study will be receiving dupilumab injections as part of their normal clinical care. Participants will be asked to attend a total of 5 scheduled visits at the study centre. Visit 0 and Visit 1 can be combined where feasible to do so. In between study visits, participants will be asked to complete some breathing tests at home. They will be asked to monitor their peak flow (maximum rate a person can breathe out) and a test for exhaled nitric oxide (FeNO) every day for the first 4 weeks of the study and then once a week afterwards. This is to monitor the usual variation in their asthma symptoms and airway function, and how this might change if they become unwell.


Adults (≥18 years old) following a clinical decision to initiate dupilumab for severe asthma after meeting licensing, local and national guidelines.

You can take part if:



You may not be able to take part if:


1. Known hypersensitivity to the active substance of dupilumab or any of the excipients2. Participation in an interventional clinical trial within 3 months of visit 1 or receipt of any investigational medicinal product within 3 months or 5 half-lives. Participation in other observational studies is acceptable if, in the view of the investigator, it will not impact the study outcomes.3. Other clinically significant medical disease or uncontrolled concomitant disease that is likely, in the opinion of the investigator, to require a change in therapy or impact the ability to participate in the study.4. Subjects on regular oral corticosteroids (OCS) and whereby the administration of dupilumab for OCS reduction will not be included in the study.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Cambridge University Hospitals NHS Foundation Trust
    Cambridge Biomedical Campus Hills Road
    Cambridge
    CB2 0QQ
  • NHS Greater Glasgow and Clyde
    J B Russell House Gartnavel Royal Hospital 1055 Great Western Road Glasgow
    Glasgow
    G12 0XH
  • Belfast Health and Social Care Trust
    Trust Headquarters A Floor - Belfast City Hospital Lisburn Road
    Belfast
    BT9 7AB
  • University Hospital Southampton NHS Foundation Trust
    Southampton General Hospital Tremona Road
    Southampton
    SO16 6YD
  • Manchester University NHS Foundation Trust
    Cobbett House Oxford Road
    Manchester
    M13 9WL
  • University Hospitals of Leicester NHS Trust
    Glenfield Hospital Groby Rd Leicester
    Leicester
    LE3 9QP
  • Guy's and St Thomas' NHS Foundation Trust
    Sydney Street
    London
    SW3 6NP

There is no guarantee that participants will receive any benefit from this study, and taking part in this study may or may not improve their asthma. Information from this study may help asthma treatment in the future. There are possible risks, disadvantages and inconveniences with any research study. The individual risks of each procedure and investigation are described fully in the participant information sheet. Participants will potentially have more tests and procedures if they take part in the study, compared to standard hospital visits. Study visits could take more time than standard hospital visits and you will have more blood taken. Each study visit can last approximately 1-3 hours. Participants will have to do additional monitoring of their asthma at home as the study requires them to keep track of their peak flow reading and lung inflammation with FeNO (approximately 10 minutes).

Prof Christopher Brightling
+44 116 250 2704
abc-3tr@leicester.ac.uk


Miss Bonnie Millar
+44 (0)116 252 2893
abc-3tr@leicester.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University of Leicester and funded by Sanofi.




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Read full details for Trial ID: ISRCTN68147929

Or CPMS 55224

Last updated 28 February 2025

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