DUPIBIO – 3TR ABC
Research type
Research Study
Full title
Biomarkers and mechanisms of asthma remission following treatment with dupilumab in adults with severe asthma - 3TR ABC.
IRAS ID
320731
Contact name
Chris Brightling
Contact email
Sponsor organisation
University of Leicester
Duration of Study in the UK
3 years, 0 months, 31 days
Research summary
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. This study is a 12 month multi-centre observational study of patients with severe asthma following initiation of treatment with dupilumab (anti-IL4Rα) as part of their standard of care. Dupilumab is given to reduce inflammation.
Subjects will be extensively characterised at baseline and reviewed throughout the year with formal clinical and biological assessments at 4, 16 and 52 weeks. Asthma remission (reduction of symptoms and use of asthma medication) will be defined for each domain: asthma control, lung function, and exacerbations as a composite measure and independently. In this research study we want to observe all participants having dupilumab injections as part of their normal clinical care. We would like to try and understand what might be causing the high levels of disease control, including the absence of symptoms and exacerbations. By doing this we hope to be able to obtain information that may help to improve asthma treatment in the future.
The study will be conducted at NHS hospitals throughout the UK and sites across Europe.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
23/EM/0031
Date of REC Opinion
21 Mar 2023
REC opinion
Favourable Opinion