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Physical Activity Promotion and Clinical Remission in Severe Asthma

keskiviikko 12. elokuuta 2026 päivittänyt: Dr Oliver Price, University of Leeds

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.

Tutkimuksen yleiskatsaus

Tila

Rekrytointi

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

140

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Tutki yhteystietojen varmuuskopiointi

Opiskelupaikat

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Active Comparator: Standard care (tezepelumab)
Tezepelumab administered according to routine clinical practice and the licensed prescribing information for the treatment of severe asthma.
Lääke: 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.
Kokeellinen: 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.
Käyttäytyminen: 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.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Daily step count
Aikaikkuna: 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.
Baseline to 3 months

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Clinical remission at 12-months
Aikaikkuna: 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
Aikaikkuna: 3 and 12-months
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
Aikaikkuna: 12-months
Annualised rate of asthma exacerbations, defined as worsening of asthma requiring treatment with rescue oral corticosteroids.
12-months
Objectively measured physical activity
Aikaikkuna: 12 months
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
Aikaikkuna: Baseline, 3 months and 12 months
Functional exercise capacity assessed using the 6-minute walk test (6MWT), with total distance walked recorded in metres.
Baseline, 3 months and 12 months

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

University of Leeds

Yhteistyökumppanit

Sheffield Teaching Hospitals NHS Foundation Trust
Hull University Teaching Hospitals NHS Trust
Mid Yorkshire Teaching NHS Trust
Bradford Institute for Health Research

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

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Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Perjantai 24. heinäkuuta 2026

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Keskiviikko 29. heinäkuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Torstai 30. heinäkuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Maanantai 17. elokuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

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Viimeksi vahvistettu

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Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • 362968

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

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-jaon aikakehys

Beginning 6 months following publication of the primary study results and ending 5 years after publication.

IPD-jaon käyttöoikeuskriteerit

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-jakamista tukeva tietotyyppi

  • STUDY_PROTOCOL
  • MAHLA
  • ANALYTIC_CODE

Lääke- ja laitetiedot, tutkimusasiakirjat

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