Physical activity promotion and clinical remission in severe asthma
Research type
Research Study
Full title
Impact of physical activity promotion on clinical remission in adults with severe asthma receiving Tezepelumab: a multicentre, open label, randomised controlled trial.
IRAS ID
362968
Contact name
Oliver Price
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Asthma is a lower airways disease affecting 350 million people globally with over 8 million in the UK. The prevalence of severe asthma is reported as 1.1% of the population and 9.5% of adults with asthma. Severe asthma is defined as asthma that requires treatment with high dose inhaled steroids plus a second controller and/or systemic steroids to prevent it from becoming “uncontrolled” or that remains “uncontrolled” despite this therapy. Severe asthma is a heterogeneous condition, and the pathophysiology of the condition is complex, with sub-types categorized based on clinical, biological, and physiological characteristics (phenotypes) and cellular and molecular mechanisms (endotypes). Asthma endotypes, including type 2 high-inflammation, type 2 low-inflammation, and mixed granulocytic asthma, are crucial for identifying and classifying patients to permit tailored treatment interventions.
With recent advances in effective therapies targeting specific pathways of inflammation, there has been a renewed interest in achieving clinical remission – defined as a high level of disease control and the absence of signs and symptoms of asthma for >12-months. However, whilst biological therapies (including Tezepelumab, the first human monoclonal antibody that blocks the activity of thymic stromal lymphopoietin) have been shown to be highly effective at improving clinical outcome measures, in most cases, not all clinical remission criteria are met. It is considered that non inflammatory issues, that is, extrapulmonary factors may be important to consider in terms of remission. It remains apparent that conventional strategies and guideline-based treatments in isolation are ineffective for some people with severe asthma and therefore it is important that future studies incorporate lifestyle intervention and behaviour change strategies alongside pharmacological intervention.
The primary objective of this study is to determine the impact of a physical activity promotion intervention on clinical remission at 12-month follow-up in adults with severe asthma receiving Tezepelumab and investigate whether those who undertake greater physical activity are more likely to achieve clinical remission. Secondary objectives are to investigate the short (3-month) and long-term (12-month) impact of Tezepelumab +/- physical activity promotion on asthma stability, daily step-count and health-related quality of life (HRQoL) i.e. innovative patient reported outcome measures capturing holistic effects of treatment.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
26/YH/0118
Date of REC Opinion
8 Jun 2026
REC opinion
Favourable Opinion