UK lung volume reduction trial
| ISRCTN | ISRCTN16371361 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16371361 |
| IRAS number | 190196 |
| Secondary identifying numbers | IRAS Project ID: 190196 |
- Submission date
- 08/11/2016
- Registration date
- 09/01/2017
- Last edited
- 12/10/2022
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Respiratory
Plain English Summary
Background and study aims
Chronic obstructive pulmonary disease (COPD) is the name for a group of lung conditions that cause breathing difficulties. In some patients with emphysema (damage to the air sacs in the lungs), an operation called lung volume reduction surgery is effective at removing the worst affected area of the lung. New techniques have been developed where emphysema can be treated using a fibre-optic camera called a bronchoscope. Studies have shown that using a bronchoscope to place implantable medical devices called endobronchial valves into the airways can be very effective in carefully selected patients and the technique is now being adopted in hospitals across the UK. The aim of this study is to collect data from people undergoing these procedures at hospitals across the UK to find out how well they work in practice and what factors influence response.
Who can participate?
Patients aged over 18 with emphysema undergoing a lung volume reduction procedure
What does the study involve?
The study involves collecting routine data about lung volume reduction procedures onto a central database. Results from across the UK can then be used to improve understanding of the procedures. Participants are not required to do anything in addition. Data is collected at the start of the study and at 3-month and 12-month follow up, including lung function data, measures of exercise capacity (maximum amount of exercise that a patient can sustain), questionnaires about health status and CT scan results.
What are the possible benefits and risks of participating?
This study will make it easier to assess lung volume reduction procedures and bring new treatments into play more quickly. There are no risks to participants.
Where is the study run from?
1. Royal Brompton Hospital (UK)
2. Glenfield Hospital (UK)
3. Addenbrooke's Hospital (UK)
4. Oxford Health NHS Foundation Trust (UK)
5. University Hospitals Bristol NHS Foundation Trust (UK)
6. Liverpool Heart and Chest NHS Foundation Trust (UK)
7. University Hospital of Wales (UK)
8. University Hospital of South Manchester NHS Foundation Trust (UK)
9. Sheffield Teaching Hospitals NHS Foundation Trust (UK)
10. Leeds Teaching Hospitals NHS Trust (UK)
11. The Newcastle on Tyne Hospitals NHS Foundation Trust (UK)
12. The Royal Wolverhampton Hospitals NHS Trust (UK)
13. Heart of England NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
April 2015 to December 2026
Who is funding the study?
British Lung Foundation (UK)
Who is the main contact?
Ms Sara Buttery
s.buttery@rbht.nhs.uk
Contact information
Public
Muscle Lab
Royal Brompton Hospital
London
SW3 6NP
United Kingdom
| Phone | +44 (0)207 351 8029 |
|---|---|
| s.buttery@rbht.nhs.uk |
Study information
| Study design | Multicentre longitudinal observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | UK Lung Volume Reduction: a multicentre observational study |
| Study acronym | UKLVR |
| Study hypothesis | COPD is poorly responsive to medical therapy, but new bronchoscopic treatments for emphysema offer the prospect of significant benefits for patients, improving lung function, exercise capacity and possibly survival. It is important to ensure that benefits seen in clinical trials are in fact reflected in clinical practice. The study will collect data on procedures being performed across the UK to establish whether the clinical effects are similar to those seen in trials and which factors predict the best outcomes. |
| Ethics approval(s) | London – Camberwell St Giles Research Ethics Committee, 21/07/2016, ref: 16/LO/1107 |
| Condition | Emphysema |
| Intervention | Lung volume reduction procedures for emphysema include lung volume reduction surgery, endobronchial valve placement, lung volume reduction coils. This study collects data from people undergoing these procedures at hospitals across the UK to evaluate how well they work in practice and what factors at baseline influence response. Baseline, 3-month and 12-month follow-up data are collected. This includes lung function data, measures of exercise capacity, questionnaires about health status and CT scan results. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Forced expiratory volume in one second, measured by spirometry at baseline and 3 months post procedure |
| Secondary outcome measures | 1. Walking distance, measured by 6 minute walk test or incremental shuttle walk test, at baseline, 3 and 12 months 2. Health status, measured by COPD assessment test (CAT) score or SGRQ at baseline, 3 and 12 months 3. Residual volume, measured by body plethysmography at baseline, 3 and 12 months |
| Overall study start date | 01/04/2015 |
| Overall study end date | 01/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 300 |
| Participant inclusion criteria | Patients aged over 18 with emphysema undergoing a lung volume reduction procedure |
| Participant exclusion criteria | Not meeting the inclusion criteria |
| Recruitment start date | 01/12/2016 |
| Recruitment end date | 31/03/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
London
SW3 6NP
United Kingdom
Leicester
LE5 4QF
United Kingdom
Cambridge
CB2 0QQ
United Kingdom
Oxford
OX4 2GX
United Kingdom
Bristol
BS1 3NU
United Kingdom
Liverpool
L14 3PE
United Kingdom
Cardiff
CF14 4XW
United Kingdom
Manchester
M23 9LT
United Kingdom
S5 7AU
United Kingdom
Leeds
LS9 7TF
United Kingdom
Newcastle on Tyne
NE7 7DN
United Kingdom
Wolverhampton
WV10 0QP
United Kingdom
Birmingham
B9 5ST
United Kingdom
Sponsor information
University/education
Faculty of Medicine Centre
Room 5L10B, Lab Block
London
W6 8RF
England
United Kingdom
"ROR" |
https://ror.org/041kmwe10 |
|---|
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- BLF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/12/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan | Participant data is held in a secure database. This includes procedures performed, lung function exercise capacity and health status measures. Researchers can apply to the trial steering committee if they have research questions that they wish to address. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
12/10/2022: The recruitment end date was updated from 01/12/2019 to 31/03/2026.
08/11/2016: Trial's existence confirmed by the NIHR.
