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RECRUITING
NCT07735494
NA

Physical Activity Promotion and Clinical Remission in Severe Asthma

Sponsor: University of Leeds

View on ClinicalTrials.gov

Summary

This study will investigate whether a structured physical activity promotion programme, delivered alongside standard treatment with tezepelumab, increases 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 compare the proportion of participants achieving clinical remission after 12 months between the two groups. Additional outcomes include objectively measured physical activity, asthma control, quality of life 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.

Official title: Impact of Physical Activity Promotion on Clinical Remission in Adults With Severe Asthma Receiving Tezepelumab: A Multicentre, Open Label, Randomised Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2026-07

Completion Date

2029-07

Last Updated

2026-07-30

Healthy Volunteers

No

Conditions

Interventions

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.

DRUG

Tezepelumab

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.

Locations (1)

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom