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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
United Kingdom
Leeds Teaching Hospitals NHS Trust
RECRUITING
Leeds
Contact Information
Primary
Oliver J Price, PhD
o.price1@leeds.ac.uk
+44(0)113 343 2909
Backup
Ian J Clifton, MD
i.clifton@nhs.net
Time Frame
Start Date: 2026-07-31
Estimated Completion Date: 2029-12-01
Participants
Target number of participants: 140
Treatments
Active_comparator: Standard care (tezepelumab)
Tezepelumab administered according to routine clinical practice and the licensed prescribing information for the treatment of severe asthma.
Experimental: Physical activity promotion plus standard care (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.
Related Therapeutic Areas
Sponsors
Collaborators: Hull University Teaching Hospitals NHS Trust, Mid Yorkshire Teaching NHS Trust, Sheffield Teaching Hospitals NHS Foundation Trust, Bradford Institute for Health Research
Leads: University of Leeds

This content was sourced from clinicaltrials.gov