UPSTREAM-COPD

  • Research type

    Research Study

  • Full title

    Effects of blocking TSLP on airway inflammation and the epithelial immune response to exacerbation triggers in patients with COPD (UPSTREAM-COPD)

  • IRAS ID

    1006721

  • Contact name

    Prof Chris Brightling

  • Contact email

    ceb17@leicester.ac.uk

  • Sponsor organisation

    Bispebjerg Hospital, Copenhagen, Denmark

  • ISRCTN Number

    ISRCTN14181775

  • Clinicaltrials.gov Identifier

    NCT05507242

  • Research summary

    COPD (chronic obstructive pulmonary disease) is a highly common chronic lung disease which carries a significant burden for both patients and healthcare systems. Treatment has been limited for a number of years. Recent studies have shown a promising new target in treating asthma – Thymic stromal lymphopoeitin (TSLP) is a protein released when the airways are irritated. This causes an increase in airway inflammation and therefore the symptoms COPD. Blocking or reducing this with a medication called tezepelumab has been shown to reduce airway inflammation in asthma. Other studies have also shown reduced symptoms and exacerbations in a diverse group of asthma patients, including in those who do not demonstrate a high level of allergic type inflammation.

    We hope to study the effect of this medication in the airway of people who suffer from COPD. We intend to do this by recruiting patients to three sites – Copenhagen, Leicester and London. These will be people with moderate to severe COPD, on standard inhaled treatment with at least one exacerbation in the preceding twelve months. Those who are willing to be involved and fulfil screening criteria will have various baseline blood and breathing tests along with questionnaires completed. Everyone will undergo a bronchoscopy – a test where a fine, flexible camera is inserted into the lungs and samples and biopsies can be taken. 50% of people will be randomised to receive the medication and 50% will receive a placebo. Each person and the team looking after them directly will not know which one they are receiving. They will receive this 4 weekly for 5 doses total, then undergo a repeat bronchoscopy and other tests. The total study time will be approximately 22 weeks. If this trial is successful it may contribute to evidence allowing us to use tezepelumab to treat COPD in future.

  • REC name

    Yorkshire & The Humber - Leeds East Research Ethics Committee

  • REC reference

    23/YH/0117

  • Date of REC Opinion

    2 Nov 2023

  • REC opinion

    Further Information Favourable Opinion