Condition category
Respiratory
Date applied
08/11/2016
Date assigned
09/01/2017
Last edited
09/01/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Trial website

Contact information

Type

Public

Primary contact

Ms Sara Buttery

ORCID ID

Contact details

Muscle Lab
Royal Brompton Hospital
London
SW3 6NP
United Kingdom
+44 (0)207 351 8029
s.buttery@rbht.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IRAS Project ID: 190196

Study information

Scientific title

UK Lung Volume Reduction: a multicentre observational 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

London – Camberwell St Giles Research Ethics Committee, 21/07/2016, ref: 16/LO/1107

Study design

Multicentre longitudinal observational study

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/04/2015

Overall trial end date

01/12/2026

Reason abandoned

Eligibility

Participant inclusion criteria

Patients aged over 18 with emphysema undergoing a lung volume reduction procedure

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

None

Recruitment start date

01/12/2016

Recruitment end date

01/12/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Brompton Hospital
Fulham Rd
London
SW3 6NP
United Kingdom

Trial participating centre

Glenfield Hospital
Groby Rd
Leicester
LE5 4QF
United Kingdom

Trial participating centre

Addenbrooke's Hospital
Hills Rd
Cambridge
CB2 0QQ
United Kingdom

Trial participating centre

Oxford Health NHS Foundation Trust
John Smith Dr
Oxford
OX4 2GX
United Kingdom

Trial participating centre

University Hospitals Bristol NHS Foundation Trust
Marlborough Street
Bristol
BS1 3NU
United Kingdom

Trial participating centre

Liverpool Heart and Chest NHS Foundation Trust
Thomas Dr
Liverpool
L14 3PE
United Kingdom

Trial participating centre

University Hospital of Wales
Heath Park
Cardiff
CF14 4XW
United Kingdom

Trial participating centre

University Hospital of South Manchester NHS Foundation Trust
Southmoor Rd
Manchester
M23 9LT
United Kingdom

Trial participating centre

Sheffield Teaching Hospitals NHS Foundation Trust
Herries Rd
S5 7AU
United Kingdom

Trial participating centre

Leeds Teaching Hospitals NHS Trust
Beckett Street
Leeds
LS9 7TF
United Kingdom

Trial participating centre

The Newcastle on Tyne Hospitals NHS Foundation Trust
Freeman Road
Newcastle on Tyne
NE7 7DN
United Kingdom

Trial participating centre

The Royal Wolverhampton Hospitals NHS Trust
Wolverhampton Rd
Wolverhampton
WV10 0QP
United Kingdom

Trial participating centre

Heart of England NHS Foundation Trust
Bordesley Green East
Birmingham
B9 5ST
United Kingdom

Sponsor information

Organisation

Imperial College London

Sponsor details

Faculty of Medicine Centre
Room 5L10B
Lab Block
London
W6 8RF
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

British Lung Foundation

Alternative name(s)

BLF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

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.

Intention to publish date

01/12/2027

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes