Condition category
Respiratory
Date applied
23/05/2016
Date assigned
23/05/2016
Last edited
01/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Chronic obstructive pulmonary disease (COPD) is the collective name for a group of diseases which affect the lungs. One of the diseases is emphysema, a lung condition in which the tiny air sacs (alveoli) in the lungs become damaged over time. In emphysema, the alveoli become overfilled with air, causing the walls to weaken and eventually burst, creating one larger air space instead of many small ones. This means that the sufferer is unable to breathe out fully, leading to breathlessness which becomes progressively worse. Lung volume reduction surgery (LVRS) is an operation in which the worst affected part of the lung is removed, making more space for the remaining healthier lung to function. There is good evidence that in properly selected individuals this can improve breathlessness and increase life expectancy. It is a major operation and does carry a risk of complications however. A more recent approach is to use a fibreoptic camera (bronchoscope) to place valves into the airways of the lung. These stop air from entering the worst-affected section of the lung causing it to collapse, leading to similar benefits of LVRS. The aim of this study is to compare the effectiveness of these two techniques in the treatment of patients with emphysema.

Who can participate?
Adults with a heterogeneous pattern of emphysema (isolated to certain areas of the lungs and to a varying extent between segments of the lungs)

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group undergo lung volume reduction surgery. Those in the second group have endobronchial valves placed into their airways using a bronchoscope while they are sedated. One year after the procedures, participants in both groups undergo a number of physical tests to find out if their lung function has improved as well as their overall quality of life.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Royal Brompton Hospital (UK)

When is the study starting and how long is it expected to run for?
April 2016 to March 2019

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Nick Hopkinson

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nick Hopkinson

ORCID ID

Contact details

Royal Brompton Hospital
Fulham Road
London
SW3 6NP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

30523

Study information

Scientific title

The CELEB trial: Comparative Effectiveness of Lung volume reduction surgery for Emphysema and Bronchoscopic lung volume reduction with valve placement

Acronym

Study hypothesis

The aim of this study is to evaluate the relative effectiveness and value of two options currently available for the treatment of COPD patients with a heterogeneous pattern of emphysema. These are lung volume reduction surgery (LVRS) and the bronchoscopic placement of endobronchial valves (BLVR).

Ethics approval

18/02/2016, ref: 16/LO/0286

Study design

Interventional; Design type: Treatment, Device, Surgery

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Specialty: Respiratory disorders, Primary sub-specialty: Respiratory disorders; UKCRC code/ Disease: Respiratory/ Other diseases of the respiratory system

Intervention

Patietns will be randomised to either unilateral video assisted thoracoscopic (VATS) lung volume reduction surgery (LVRS) or endobronchial valves (BLVR) placed to achieve lobar occlusion.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Change in iBODE score (a composite of BMI, FEV1, MRC dyspnoea score and shuttle walk test distance) one year post procedure.

Secondary outcome measures

1. Health related quality of life is measured using the COPD assessment test score (CAT)
2. Physical activity level
3. Change in residual volume (RV)
4. Fat free mass

Overall trial start date

01/04/2016

Overall trial end date

31/03/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults (aged 18 or over) with COPD
2. FEV1 <60% predicted
3. Significant hyperinflation (TLC>100% predicted, RV>170% predicted)
4. Ex-smoker >3 months
5. MRC dyspnoea score 3 or more 
6. CT scan assessed at MDT to have intact interlobar fissures (>90%) and heterogeneous emphysema
7. Provision of informed consent to participate 

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 76; UK Sample Size: 76

Participant exclusion criteria

1. Smoking within 3 months
2. CT scan shows interlobar fissures are not intact
3. Major comorbidity limiting survival
4. Significant pulmonary fibrosis
5. FEV1 and TLco <20%
6. PaO2 < 7.0kPa
7. PaO2 > 7kPa
8. Presence of interlobar collateral ventilation assessed by Chartis system

Recruitment start date

01/06/2016

Recruitment end date

01/06/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Brompton Hospital
Fulham Road
London
SW3 6NP
United Kingdom

Sponsor information

Organisation

Royal Brompton and Harefield NHS Foundation Trust

Sponsor details

Fulham Road
London
SW3 6NP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

01/08/2016: Internal review.