Newcastle Clinical Trials Unit

E-CLAD UK

Extracorporeal Photophoresis in the treatment of Chronic Lung Allograft Dysfunction: a randomised controlled trial (E-CLAD UK).

  • Study stage: Recruiting
  • Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust
  • Funder:  NIHR EME
  • Therapeutic area: Cardiovascular
  • Type of study: CTIMP

Aim: To determine if extracorporeal photopheresis (ECP) therapy plus standard of care (SOC) is more effective at improving or stabilising lung function in lung transplant recipients with chronic lung allograft dysfunction (CLAD) compared to SOC alone

Primary Outcome: Composite responder outcome of lung function stabilisation derived from change in Forced Expiratory Volume (FEV1) and Forced Vital Capacity (FVC) at 12 and 24 weeks compared to baseline at study entry.

  • Clinical Phase: II
  • Population: Adults
  • Design: RCT (open label)
  • Setting: Secondary Care
  • Planned Sample Size: 90