E-CLAD UK Long-term

Extracorporeal photopheresis in the treatment of chronic lung allograft dysfunction: long-term follow-up study

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN15882212

Enrollment

Registered

2026-08-04

Start date

2024-07-23

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic lung allograft dysfunction Respiratory

Interventions

The study is a follow on from the E-CLAD study. https://www.isrctn.com/ISRCTN10615985 E-CLAD UK Long-term is an observational study. Participants will be required to complete two different quality of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Consented and subsequently randomised to the E-CLAD UK clinical trial 2. Capacity to provide written informed consent to E-CLAD UK Long-term 3. Completed participation in the E-CLAD UK clinical trial

Exclusion criteria

Exclusion criteria: 1. Any participants that are consented to the E-CLAD UK clinical trial but during final eligibility checks are found to not meet eligibility requirements and are therefore not subsequently randomised to the E-CLAD UK clinical trial would not be eligible for E-CLAD UK Long-term 2. Lacking capacity to provide written informed consent to E-CLAD UK Long-term

Design outcomes

Primary

Measure	Time frame
Incremental cost per quality-adjusted life year gained measured using Cost-effectiveness modelling using EQ-5D-5L responses for QALY estimation and health care usage data from E-CLAD UK clinical trial and E-CLAD UK Long-term at 52 weeks, 104 weeks post commencement	—

Secondary

Measure	Time frame
Rate of decline in lung function measured using Forced expiratory volume in 1 second and forced vital capacity obtained from routine clinical pulmonary function tests recorded in case report forms at 52 weeks, 104 weeks;Absolute change in lung function measured using Forced expiratory volume in 1 second and forced vital capacity obtained from routine clinical pulmonary function tests recorded in case report forms at 52 weeks, 104 weeks;Health care utilisation measured using Case report forms completed using data from routine clinical notes including medication changes, blood tests, chest X-rays and new interventions at 24 weeks, 52 weeks, 104 weeks;Health-related quality of life measured using EQ-5D-5L and SF-36 v2 Quality of Life Questionnaires at 24 weeks, 52 weeks, 104 weeks;Survival status measured using Review of patient medical records at 104 weeks	—

Measure

Time frame

Rate of decline in lung function measured using Forced expiratory volume in 1 second and forced vital capacity obtained from routine clinical pulmonary function tests recorded in case report forms at 52 weeks, 104 weeks;Absolute change in lung function measured using Forced expiratory volume in 1 second and forced vital capacity obtained from routine clinical pulmonary function tests recorded in case report forms at 52 weeks, 104 weeks;Health care utilisation measured using Case report forms completed using data from routine clinical notes including medication changes, blood tests, chest X-rays and new interventions at 24 weeks, 52 weeks, 104 weeks;Health-related quality of life measured using EQ-5D-5L and SF-36 v2 Quality of Life Questionnaires at 24 weeks, 52 weeks, 104 weeks;Survival status measured using Review of patient medical records at 104 weeks

—

Countries

England, United Kingdom

Contacts

Public Contact- Trial Manager

e-clad@newcastle.ac.uk-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 25, 2026