Physical Activity Promotion and Clinical Remission in Severe Asthma

Официальное название

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

Обзор

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.

Подробное описание

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 the proportion of adults with severe asthma achieving 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 is the proportion of participants achieving clinical remission at 12 months. Secondary outcomes include objectively measured physical activity, asthma control, health-related quality of life 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.

Вмешательства

• Поведенческое 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 Capabilit
• Препарат 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.

Первичные конечные точки

• Clinical remission [Срок оценки: 12 months after randomisation]

Вторичные конечные точки (4)

• Asthma disease stability [Срок оценки: 3 and 12 months]
• Severe asthma exacerbations [Срок оценки: 12 months]
• Physical activity [Срок оценки: Baseline, 3 and 12 months]
• Functional exercise capacity [Срок оценки: Baseline, 3 and 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Великобритания · 1 центр

• Leeds Teaching Hospitals NHS Trust — Leeds

Идентификаторы

NCT: NCT07735494 · 362968

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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