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dc.contributor.authorFisher, Andrew J
dc.contributor.authorWhite, Michael
dc.contributor.authorGoudie, Nicola
dc.contributor.authorKershaw, Anneka
dc.contributor.authorPhillipson, Julia
dc.contributor.authorBardgett, Michelle
dc.contributor.authorLally, Joanne
dc.contributor.authorBevin-Nicholls, Alex
dc.contributor.authorChadwick, Thomas
dc.contributor.authorBryant, Andrew
dc.contributor.authorRussell, Sian
dc.contributor.authorSmith, Hesther
dc.contributor.authorFrisby, Laura
dc.contributor.authorErrington, Rebecca
dc.contributor.authorCarby, Martin
dc.contributor.authorThompson, Richard
dc.contributor.authorSanthanakrishnan, Karthik
dc.contributor.authorParmar, Jasvir
dc.contributor.authorLordan, James L
dc.contributor.authorVale, Luke
dc.contributor.authorHancock, Helen
dc.contributor.authorExley, Catherine
dc.contributor.authorGennery, Andrew R
dc.contributor.authorWason, James Ms
dc.date.accessioned2024-06-04T12:48:11Z
dc.date.available2024-06-04T12:48:11Z
dc.date.issued2024-05-09
dc.identifier.citationFisher AJ, White M, Goudie N, Kershaw A, Phillipson J, Bardgett M, Lally J, Bevin-Nicholls A, Chadwick T, Bryant A, Russell S, Smith H, Frisby L, Errington R, Carby M, Thompson R, Santhanakrishnan K, Parmar J, Lordan JL, Vale L, Hancock H, Exley C, Gennery AR, Wason JM. Extracorporeal photopheresis (ECP) in the treatment of chronic lung allograft dysfunction (CLAD): a prospective, multicentre, open-label, randomised controlled trial studying the addition of ECP to standard care in the treatment of bilateral lung transplant patients with CLAD (E-CLAD UK). BMJ Open Respir Res. 2024 May 9;11(1):e001995. doi: 10.1136/bmjresp-2023-001995.en_US
dc.identifier.eissn2052-4439
dc.identifier.doi10.1136/bmjresp-2023-001995
dc.identifier.pmid38724453
dc.identifier.urihttp://hdl.handle.net/20.500.14200/4764
dc.description.abstractBackground: Long-term survival after lung transplantation is limited compared with other organ transplants. The main cause is development of progressive immune-mediated damage to the lung allograft. This damage, which can develop via multiple immune pathways, is captured under the umbrella term chronic lung allograft dysfunction (CLAD). Despite the availability of powerful immunosuppressive drugs, there are presently no treatments proven to reverse or reliably halt the loss of lung function caused by CLAD. The aim of the E-CLAD UK trial is to determine whether the addition of immunomodulatory therapy, in the form of extracorporeal photopheresis (ECP), to standard care is more efficacious at stabilising lung function in CLAD compared with standard care alone. Methods and analysis: E-CLAD UK is a Phase II clinical trial of an investigational medicinal product (Methoxsalen) delivered to a buffy coat prepared via an enclosed ECP circuit. Target recruitment is 90 bilateral lung transplant patients identified as having CLAD and being treated at one of the five UK adult lung transplant centres. Participants will be randomised 1:1 to intervention plus standard of care, or standard of care alone. Intervention will comprise nine ECP cycles spread over 20 weeks, each course involving two treatments of ECP on consecutive days. All participants will be followed up for a period of 24 weeks.The primary outcome is lung function stabilisation derived from change in forced expiratory volume in one second and forced vital capacity at 12 and 24 weeks compared with baseline at study entry. Other parameters include change in exercise capacity, health-related quality of life and safety. A mechanistic study will seek to identify molecular or cellular markers linked to treatment response and qualitative interviews will explore patient experiences of CLAD and the ECP treatment.A patient and public advisory group is integral to the trial from design to implementation, developing material to support the consent process and interview materials. Ethics and dissemination: The East Midlands-Derby Research Ethics Committee has provided ethical approval (REC 22/EM/0218). Dissemination will be via publications, patient-friendly summaries and presentation at scientific meetings. Trial registration number: EudraCT number 2022-002659-20; ISRCTN 10615985.en_US
dc.language.isoenen_US
dc.publisherBMJ Publishing Groupen_US
dc.relation.urlhttp://bmjopenrespres.bmj.com/en_US
dc.rights© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
dc.subjectRespiratory medicineen_US
dc.subjectTransplantationen_US
dc.titleExtracorporeal photopheresis (ECP) in the treatment of chronic lung allograft dysfunction (CLAD): a prospective, multicentre, open-label, randomised controlled trial studying the addition of ECP to standard care in the treatment of bilateral lung transplant patients with CLAD (E-CLAD UK).en_US
dc.typeArticleen_US
dc.typeOtheren_US
dc.source.journaltitleBMJ Open Respiratory Researchen_US
dc.source.volume11
dc.source.issue1
dc.source.countryEngland
rioxxterms.versionNAen_US
dc.contributor.trustauthorThompson, Richard
dc.contributor.departmentRespiratoryen_US
dc.contributor.roleMedical and Dentalen_US
oa.grant.openaccessnaen_US


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