Impact of Physical Activity Promotion on Clinical Remission in Adults With Severe Asthma Receiving Tezepelumab: A Multicentre, Open Label, Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Clinical remission
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-70 years.
- •Physician-diagnosed severe asthma.
- •Eligible for tezepelumab according to NICE TA
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Physical activity promotion (Behavioral)
Standard care (tezepelumab)
Tezepelumab administered according to routine clinical practice and the licensed prescribing information for the treatment of severe asthma.
干预措施: Tezepelumab (Drug)
结局指标
主要结局
Clinical remission
时间窗: 12 months after randomisation
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.
Daily step count
时间窗: Baseline to 3 months
Change in mean daily step count from baseline to 3 months, assessed over 7 consecutive days using a wrist-worn ActiGraph accelerometer.
次要结局
- 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)
- Clinical remission at 12-months(12-months)
- Disease stability(3 and 12-months)
- Annualised asthma exacerbation rate(12-months)
- Objectively measured physical activity(12 months)
- Functional exercise capacity(Baseline, 3 months and 12 months)
研究者
Dr Oliver Price
Associate Professor
University of Leeds