Health TrialsbyHealthPanel

Physical Activity Promotion and Clinical Remission in Severe Asthma

ConditionSevere Asthma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Leeds

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Physical activity promotion

    Behavioral

    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

    Drug

    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.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Standard care (tezepelumab)Active comparator 1 intervention
Group B: Physical activity promotion plus standard care (tezepelumab)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

Annualised asthma exacerbation rate

Annualised rate of asthma exacerbations, defined as worsening of asthma requiring treatment with rescue oral corticosteroids.

Time frame
12-months
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Leeds

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Collaborator

Bradford Institute for Health Research

Collaborator

Mid Yorkshire Teaching NHS Trust

Collaborator

Sheffield Teaching Hospitals NHS Foundation Trust

Collaborator

Source ClinicalTrials.gov
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