TEZEBIO – 3TR ABC
Research type
Research Study
Full title
Biomarkers and mechanisms of asthma remission following treatment with Tezepelumab in adults with severe asthma – 3TR ABC
IRAS ID
323812
Contact name
Chris Brightling
Contact email
Sponsor organisation
University of Leicester
Duration of Study in the UK
5 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 36 month multicentre observational study of patients with severe asthma following initiation of treatment treatment with Tezepelumab (anti-TSLP) as part of their standard of care. Subjects will be extensively characterized at baseline; reviewed throughout the year with formal clinical and biological assessment at 4, 16, 52 weeks, 2 years and 3 years. Asthma remission will be defined for each domain: asthma control, lung function, and exacerbations as a composite measure and independently. Biomarkers and multi-omic analysis will be undertaken in the biosamples to determine biological pathways and bio-signatures associated with asthma remission. Primary outcome will be assessed at 1 year. In this research study we want to observe all participants having tezepelumab 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/0072
Date of REC Opinion
21 Mar 2023
REC opinion
Favourable Opinion