Physical Activity Promotion and Clinical Remission in Severe Asthma
Recruiting · NCT07735494 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Leeds
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This study will investigate whether a structured physical activity promotion programme, delivered alongside standard treatment with tezepelumab, increases objectively measured physical activity and the proportion of adults with severe asthma achieving clinical remission compared with standard care alone. Although biologic therapies have improved asthma control for many people with severe asthma, many individuals remain physically inactive, experience reduced exercise tolerance, and continue to report symptoms that affect their quality of life. Physical inactivity may represent a modifiable factor that limits the achievement of optimal health outcomes. Adults with severe asthma who are starting tezepelumab as part of routine clinical care will be randomly assigned to receive either standard care alone or standard care plus a 12-week physical activity promotion programme. The programme includes an individual consultation, group behavioural support sessions, personalised goal setting, self-monitoring using a smartphone application, and strategies to help participants increase and maintain their physical activity levels. Participants will be followed for 12 months. The study will primarily assess change in objectively measured daily step count after 3 months. The primary clinical outcome will be the proportion of participants achieving clinical remission after 12 months. Additional outcomes include asthma disease stability, asthma exacerbations, objectively measured physical activity at 12 months and functional exercise capacity. The findings will help determine whether combining physical activity promotion with biologic therapy improves outcomes for adults with severe asthma and could inform future models of routine severe asthma care.
Who can take part
Inclusion criteria
- Adults aged 18-70 years.
- Physician-diagnosed severe asthma.
- Eligible for tezepelumab according to NICE TA880.
- History of ≥3 asthma exacerbations requiring oral corticosteroids in the previous 12 months or receiving maintenance oral corticosteroid therapy.
- Objective confirmation of asthma, including bronchodilator reversibility, bronchial hyperresponsiveness and/or variable airflow obstruction, as part of routine clinical assessment.
- Decision to commence tezepelumab made by the treating multidisciplinary severe asthma team prior to study enrolment.
- Able and willing to provide written informed consent.
Exclusion criteria
- Non-asthma respiratory disease that may confound study outcomes (e.g. obstructive sleep apnoea).
- Pregnancy.
- Significant non-asthma medical conditions likely to impair physical activity or functional exercise capacity (e.g. acute musculoskeletal injury).
- Any condition that, in the opinion of the investigator, would make participation unsafe or compromise study completion.
Where it is running
1 location listed.
- Leeds Teaching Hospitals NHS Trust - Leeds, United Kingdom