An interventional study of Physical activity promotion and Tezepelumab in Severe Asthma, sponsored by University of Leeds. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by University of Leeds · Not applicable, Interventional, and Treatment
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.
Severe asthma is associated with persistent symptoms, reduced physical activity, impaired exercise capacity, and poor health-related quality of life despite advances in pharmacological management. Although biologic therapies such as tezepelumab have substantially improved asthma control and increased rates of clinical remission, many individuals continue to experience functional limitations and remain physically inactive. Physical inactivity has emerged as a potentially modifiable treatable trait associated with poorer clinical outcomes, suggesting that interventions targeting physical activity may complement biologic therapy and improve broader health outcomes.
This multicentre, open-label, randomised controlled trial will evaluate whether a structured physical activity promotion programme delivered alongside standard treatment with tezepelumab increases objectively measured physical activity and improves clinical outcomes, including clinical remission, compared with standard care alone. Adults initiating tezepelumab as part of routine clinical care at participating UK severe asthma centres will be randomised in a 1:1 ratio to receive either standard care or standard care plus a 12-week physical activity promotion intervention.
The physical activity intervention is informed by the Capability, Opportunity, Motivation-Behaviour (COM-B) framework and incorporates evidence-based behaviour change techniques including personalised goal setting, action planning, self-monitoring using a smartphone application, individual behavioural consultation, and six online group support sessions delivered over 12 weeks. Following completion of the intervention, participants will continue to be followed for a total of 12 months to evaluate the maintenance of behavioural and clinical outcomes.
The primary outcome will be change in objectively measured daily step count from baseline to 3-months. The primary clinical outcome will be the proportion of participants achieving clinical remission on treatment at 12-months. Secondary outcomes include asthma disease stability at 3 and 12-months, defined as achievement of ≥2 clinical remission characteristics, annualised asthma exacerbation rate, objectively measured physical activity at 12-months, and functional exercise capacity. The study will also examine whether baseline clinical and behavioural characteristics are associated with response to the physical activity intervention. The findings will determine whether integrating structured physical activity promotion with biologic therapy provides additional clinical benefit beyond pharmacological treatment alone and may inform future remission-focused models of severe asthma care.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 140 is above the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →University of Leeds is the lead sponsor of 206 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tezepelumab administered according to routine clinical practice and the licensed prescribing information for the treatment of severe asthma.
Drug: Tezepelumab
Participants will receive standard care for severe asthma, including tezepelumab administered according to routine clinical practice and the licensed prescribing information, together with a 12-week structured physical activity promotion programme incorporating evidence-based behaviour change techniques to increase and maintain daily physical activity. Participants will undergo study assessments at baseline, 3 months, and 12 months.
Behavioral: Physical activity promotion
A 12-week structured physical activity promotion programme delivered alongside standard care for severe asthma. The intervention comprises an individual behavioural consultation followed by six online group support sessions delivered every two weeks. It incorporates evidence-based behaviour change techniques, including personalised goal setting, action planning, self-monitoring using the Active10 smartphone application, feedback, problem solving, and relapse prevention, informed by the Capability, Opportunity, Motivation-Behaviour (COM-B) framework to support sustained increases in daily physical activity.
Tezepelumab administered according to the licensed prescribing information and routine clinical practice for the treatment of severe asthma. All participants receive tezepelumab as standard care throughout the study.
Daily step count
Change in mean daily step count from baseline to 3 months, assessed over 7 consecutive days using a wrist-worn ActiGraph accelerometer.
Time frame: Baseline to 3 months
Clinical remission at 12-months
Clinical remission on treatment will be defined as fulfilment of all predefined remission criteria: no asthma exacerbations requiring rescue oral corticosteroids, no daily maintenance oral corticosteroid use, lung function ≥0.95 of baseline, and an Asthma Control Questionnaire-5 (ACQ-5) score \<1.5.
Time frame: 12-months
Disease stability
Proportion of participants achieving asthma disease stability, defined as achievement of ≥2 predefined clinical remission characteristics: no asthma exacerbations requiring rescue oral corticosteroids, no daily maintenance oral corticosteroid use, lung function ≥0.95 of baseline, and ACQ-5 \<1.5.
Time frame: 3 and 12-months
Annualised asthma exacerbation rate
Annualised rate of asthma exacerbations, defined as worsening of asthma requiring treatment with rescue oral corticosteroids.
Time frame: 12-months
Objectively measured physical activity
Objectively measured physical activity assessed over 7 consecutive days using a wrist-worn ActiGraph accelerometer, including absolute daily step count, physical activity intensity, and total and active energy expenditure.
Time frame: 12 months
Functional exercise capacity
Functional exercise capacity assessed using the 6-minute walk test (6MWT), with total distance walked recorded in metres.
Time frame: Baseline, 3 months and 12 months
Plan to share: Yes — Individual participant data that underlie the results reported in publications (after de-identification) will be made available to researchers upon reasonable request to the corresponding author. Requests will be considered by the study investigators and sponsor, subject to institutional approvals, data sharing agreements, and applicable ethical and regulatory requirements.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Beginning 6 months following publication of the primary study results and ending 5 years after publication.
Access criteria: De-identified individual participant data underlying the published results, together with the study protocol, statistical analysis plan and analytic code, will be made available to qualified researchers upon reasonable request to the corresponding author. Requests will be reviewed by the study investigators and sponsor and will require a data sharing agreement and compliance with applicable ethical, legal and institutional requirements.
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