E-CLAD UK Long-term
| ISRCTN | ISRCTN15882212 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15882212 |
| Integrated Research Application System (IRAS) | 338850 |
| Central Portfolio Management System (CPMS) | 60828 |
| Sponsor | Newcastle upon Tyne Hospitals NHS Foundation Trust |
| Funder | Therakos |
- Submission date
- 22/05/2026
- Registration date
- 04/08/2026
- Last edited
- 04/08/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
This study looks at the long term effects of a treatment called extracorporeal photopheresis (ECP) in people who have had a double lung transplant and later develop chronic lung allograft dysfunction. This condition means the body starts to reject the transplanted lungs over time. An earlier study followed people for 24 weeks, but it did not show the longer term impact of the treatment. This follow up study aims to understand how the treatment affects health, quality of life, and use of health services over a longer period of up to two years. It also looks at whether the treatment offers good value for money compared to standard care alone.
Who can participate?
Adults who took part in the earlier E-CLAD UK clinical trial can join this follow up study. They must have completed the original trial and be able to give written consent. Healthy volunteers cannot take part.
What does the study involve?
Participants will be asked to complete two short quality of life questionnaires at up to three time points over two years. Each questionnaire takes about ten minutes and can be completed online using a phone, tablet, or computer.
Information about participants’ health, treatments, and use of NHS services will also be collected from their medical records at around 52 weeks and 104 weeks.
Some participants, up to 20 people, may be invited to take part in a telephone or video interview lasting about one hour. This will explore their experiences of treatment and care.
What are the possible benefits and risks of participating?
There may be no direct benefit to participants, but the study will help improve understanding of long term outcomes for people with this condition and may benefit future patients.
There are no known risks from taking part in this study, as it mainly involves questionnaires and review of medical records.
Where is the study run from?
Newcastle Clinical Trials Unit (UK)
When is the study starting and how long is it expected to run for?
July 2024 to December 2029.
Who is funding the study?
Therakos (UK)
Who is the main contact?
e-clad@newcastle.ac.uk
Contact information
Public, Scientific
Newcastle Clinical Trials Unit, Newcastle University, Baddiley-Clark Building, Richardson Road
Newcastle upon Tyne
NE2 4AX
United Kingdom
| e-clad@newcastle.ac.uk |
Principal investigator
Newcastle University
William Leech Building, Medical School
Newcastle University
Newcastle upon Tyne
NE2 4HH
United Kingdom
 ORCID ID |
0000-0003-4822-7223 |
|---|---|
| Phone | +44 1912088696 |
| a.j.fisher@ncl.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Longitudinal study |
| Scientific title | Extracorporeal photopheresis in the treatment of chronic lung allograft dysfunction: long-term follow-up study |
| Study acronym | E-CLAD UK Long-term |
| Study objectives | The primary objective of the E-CLAD UK long-term follow-up study is to determine whether ECP therapy plus standard care is more cost-effective than standard care alone at managing lung function in patients with CLAD following double lung transplant. |
| Ethics approval(s) |
Approved 22/04/2024, West Midlands - South Birmingham Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; no telephone number provided; southbirmingham.rec@hra.nhs.uk), ref: 24/WM/0075 |
| Health condition(s) or problem(s) studied | Chronic lung allograft dysfunction |
| Methodology | 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 life questionnaires at up to three different time points over a two-year period. The timepoints will depend on whether participants completed the 24-week visit in the E-CLAD UK trial. The questionnaires will be the same as those used in the original trial and should take no more than ten minutes to complete. The first timepoint will coincide with the scheduled week-24 visit for the E-CLAD UK trial. Should participants reach this study visit in the original trial then they will be completed as part of the E-CLAD UK trial and will not be repeated for this study. Questionnaires will then be repeated at 52 weeks and 104 weeks after the start of participants involvement in the E-CLAD UK trial. Questionnaires will be set up to allow participants to complete remotely on a mobile phone, tablet, computer or laptop. Consent will be obtained to allow the collection of additional information from participant's medical records. This will be information on their condition, any further treatments received and their usage of the NHS. This information will be collected by the research team at the participant's local hospital. This information will be collected at the 52- and 104-week timepoint. Participants will also be invited to be interviewed as part of a qualitative sub-study. Up to 20 participants will take part in an interview about their long-term views on their medical treatment during the trial and subsequent post-trial care. Interviews will be conducted remotely and expected to last about an hour. |
| Intervention type | Drug |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | UVADEX [Methoxsalen] |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 31/12/2029 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 90 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 23/07/2024 |
| Date of final enrolment | 30/06/2029 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
England
Cambridge Biomedical Campus
Cambridge
CB2 0AY
England
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
England
Oxford Road
Manchester
M13 9WL
England
Westminster Bridge Road
London
SE1 7EH
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
22/05/2026: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
