Structured physical activity program added to tezepelumab for adults with severe asthma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicentre, open-label randomized trial tests whether a structured physical activity promotion program, delivered alongside tezepelumab, increases objectively measured physical activity and the rate of clinical remission compared with standard care alone. Participants are adults with severe asthma starting tezepelumab and are randomized 1:1 to receive standard care or standard care plus the 12-week intervention. The program uses the COM-B framework and behavior-change techniques such as goal setting, action planning, and self-monitoring to support activity. Outcomes include physical activity measurements and clinical remission status.

Why it matters

Who can join: the full rules

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's running

• Leeds Teaching Hospitals NHS Trust
  Leeds, United Kingdom Recruiting

Study contacts

• Study coordinator: Oliver J Price, PhD
• Email: o.price1@leeds.ac.uk
• Phone: +44(0)113 343 2909

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.