Physical Activity Promotion and Clinical Remission in Severe Asthma

NCT07735494 | Recruiting

• 1 other identifier: 362968
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Severe Asthma

Keywords

Severe Asthma; Treatable Traits; Tezepelumab; Self-management; Behavioural Intervention

Outcome Measures

Primary Outcomes (1)

• Clinical remission

  The proportion of participants achieving clinical remission 12 months after randomisation. Clinical remission is defined as: (1) no rescue oral corticosteroid-treated exacerbations; (2) no daily maintenance oral corticosteroid use (0 mg); (3) preservation of lung function, defined as a pre-bronchodilator FEV₁ ≥95% of the participant's baseline pre-bronchodilator FEV₁; and (4) well-controlled asthma symptoms, defined as an Asthma Control Questionnaire-5 (ACQ-5) score \<1.5.

  12 months after randomisation

Secondary Outcomes (4)

• Asthma disease stability

  3 and 12 months

• Severe asthma exacerbations

  12 months

• Physical activity

  Baseline, 3 and 12 months

• Functional exercise capacity

  Baseline, 3 and 12 months

Study Arms (2)

Standard care (tezepelumab)

ACTIVE COMPARATOR

Tezepelumab administered according to routine clinical practice and the licensed prescribing information for the treatment of severe asthma.

Drug: Tezepelumab

Physical activity promotion plus standard care (tezepelumab)

EXPERIMENTAL

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

Interventions

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.

Physical activity promotion plus standard care (tezepelumab)

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.

Standard care (tezepelumab)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Leeds: lead
• 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

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

tezepelumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Oliver J Price, PhD

CONTACT

+44(0)113 343 2909; o.price1@leeds.ac.uk

Ian J Clifton, MD

CONTACT

i.clifton@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomly allocated (1:1) to one of two parallel groups: standard care with tezepelumab or standard care with tezepelumab plus a structured physical activity promotion programme.

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 30, 2026
• Study Start: July 1, 2026
• Primary Completion: July 31, 2026
• Study Completion (Estimated): July 1, 2029
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 6 months following publication of the primary study results and ending 5 years after publication.
• 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.

Locations

GB (1)