Physical Activity Promotion and Clinical Remission in Severe Asthma

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

Study Overview

• Status: Recruiting
• Conditions: Severe Asthma
• Intervention / Treatment: Drug: Tezepelumab; Behavioral: Physical activity promotion

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Oliver J Price, PhD; Phone Number: +44(0)113 343 2909; Email: o.price1@leeds.ac.uk
• Study Contact Backup: Name: Ian J Clifton, MD; Email: i.clifton@nhs.net

Study Locations

• United Kingdom
  • Leeds, United Kingdom, LS9 7TF
    • Recruiting
    • Leeds Teaching Hospitals NHS Trust
    • Contact: Ian J Clifton, MD; Email: i.clifton@nhs.net
    • Contact: Oliver J Price, PhD; Email: o.price1@leeds.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard care (tezepelumab); Tezepelumab administered according to routine clinical practice and the licensed prescribing information for the treatment of severe asthma.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	3 and 12-months
Annualised asthma exacerbation rate	Annualised rate of asthma exacerbations, defined as worsening of asthma requiring treatment with rescue oral corticosteroids.	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.	12 months
Functional exercise capacity	Functional exercise capacity assessed using the 6-minute walk test (6MWT), with total distance walked recorded in metres.	Baseline, 3 months and 12 months

Collaborators and Investigators

• Sponsor: University of Leeds
• Collaborators: Sheffield Teaching Hospitals NHS Foundation Trust; Hull University Teaching Hospitals NHS Trust; Mid Yorkshire Teaching NHS Trust; Bradford Institute for Health Research

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: July 24, 2026
• First Submitted That Met QC Criteria: July 29, 2026
• First Posted (Actual): July 30, 2026

Study Record Updates

• Last Update Posted (Actual): August 17, 2026
• Last Update Submitted That Met QC Criteria: August 12, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Severe Asthma; Self-management; Tezepelumab; Behavioural Intervention; Treatable Traits
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; tezepelumab
• Other Study ID Numbers: 362968

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning 6 months following publication of the primary study results and ending 5 years after publication.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No