Condition category
Respiratory
Date applied
18/06/2015
Date assigned
28/07/2017
Last edited
27/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Bronchiectasis is a long-term rare condition where the airways are abnormally widened (called bronchial dilatation), resulting in the build-up of mucus that can cause infection in the lungs. Symptoms include a persistent cough and breathlessness. There is a need to know more about how to treat bronchiectasis and how many patients there are in the UK with this condition. This study involves recording information about patients that are diagnosed with bronchiectasis and storing it in a registry. Currently there are very few drugs or treatments that are proven to work for bronchiectasis because very few clinical trials have been performed. The data collected in the registry will help us to evaluate how well treatments work and help to design better clinical trials by understanding more about the disease.

Who can participate?
Adults aged at 18 and older with bronchiectasis.

What does the study involve?
This study stores simple information about each participant, such as their age, the results of blood tests and x-rays and the treatments that they have or are receiving. This will help us to understand the impact of bronchiectasis on each participant, and on healthcare in the UK. Those asking for a data analysis to be conducted on the database may include doctors, university researchers and companies including the pharmaceutical industry. Participants that are willing to take part in clinical trials in the future are also identified and their contact details stored on file. Participants are asked to consent to the study period where funding is already identified namely a study duration of 36 months. The overall principle of the study is to collate data from routinely collected investigations as recommended in care guidelines with participants then followed up at least once a year.

What are the possible benefits and risks of participating?
There are no direct benefits or risks with participating.

Where is the study run from?
A number of NHS sites (at least 9) in the UK.

When is the study starting and how long is it expected to run for?
November 2014 to October 2017

Who is funding the study?
Medical Research Council (UK)

Who is the main contact?
Dr Susan Bowett
susan.bowett@ncl.ac.uk

Trial website

www.bronch.ac.uk

Contact information

Type

Public

Primary contact

Dr Susan Bowett

ORCID ID

Contact details

Faculty of Medical Sciences
Newcastle University
M3045
3rd Floor
William Leech Building
Framlington Place
Newcastle upon Tyne
NE2 4HH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7378

Study information

Scientific title

Bronchiectasis multi-centre observational cohort and biobank UK study

Acronym

BronchUK

Study hypothesis

The United Kingdom Bronchiectasis Registry (BronchUK) is a national research database and biobank of adults with bronchiectasis. The aim is to facilitate clinical trials and academic research studies in order to improve our understanding of what causes bronchiectasis and to find better, more effective treatments for people with this condition

Ethics approval

NRES Committee North East - Newcastle & North Tyneside 1, 17/07/2015, ref: 15/NE/0172

Study design

Multi-centre observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

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

Condition

Adults resident in the UK with bronchiectasis

Intervention

This is an observational study. No interventions are undertaken as part of the study itself.

Once consented, participants have data extraction undertaken from their clinical notes. The data fields required include demographics, routine haematology, biochemistry and bronchiectasis aetiological investigations as per the UK Bronchiectasis guidelines (such as immunoglobulin levels and in selected cases Cystic fibrosis gene testing).

Data on age, gender, medications, past medical history and past test results relevant to bronchiectasis (such as CT scans, microbiology and immune tests) is collected. This information is recorded in a secure computer database, independent from the research team, which is held on a secure NHS-hosted computer system at the Farr Institute, Dundee. A series of questionnaires are completed annually which records how bronchiectasis affects patients’ quality of life. These questionnaires include (Qol-B, EQ5D and SGRQ). At each visit, 40 millilitres (8 teaspoons) of blood and a sample of sputum (where possible) are taken with the intention to be used for future studies to understand aspects of bronchiectasis, inflammation, genetics and infections.

It is planned to use the biobank as the basis for future clinical research. However, such studies will be the subject of separate requests for approvals, with distinct protocols. The registry may be used to help recruitment into future clinical trials. Potential participants are identified by case-note review and attendance at outpatient clinics. All aetiologies or suspected aetiologies of bronchiectasis are eligible for entry into the observational cohort. It is preferred that the recruitment at each centre is based on a consecutive sample to avoid recruitment bias.

Intervention type

Phase

Drug names

Primary outcome measures

Develop and implement a cross sectional multi-centre observational cohort and biobank.

Secondary outcome measures

1. To evaluate and further define clinical outcomes longitudinally
2. To biobank serum and DNA from the cohort
3. To follow up entrants assessing mortality and morbidity

Overall trial start date

01/11/2014

Overall trial end date

30/10/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participant has capacity to provide written informed consent
2. Aged 18 years or over
3. Clinical and radiological diagnosis of bronchiectasis (documented) as defined by historical evidence of bronchiectasis on Computerised Tomographic (CT) scanning. Either CT or High resolution CT scanning (HRCT) is acceptable.
4. English speaking / access to interpreter (ability to complete quality of life questionnaires)
5. Exacerbation frequency – no lower threshold
6. Any suspected aetiological cause of bronchiectasis (except cystic fibrosis)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1500

Participant exclusion criteria

1. Cognitive impairment
2. Non-English speaking/ unable to access interpreter
3. Terminal illness not related to bronchiectasis
4. Aged <18 years
5. Bronchiectasis is not main or co-dominant respiratory disease
6. Lung transplantation for previous bronchiectasis
7. Inability to attend yearly clinical follow up

Recruitment start date

01/08/2015

Recruitment end date

30/10/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Newcastle upon Tyne Hospitals NHS Foundation Trust
Freeman Hospital, Freeman Road, High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom

Trial participating centre

Royal Brompton and Harefield NHS Foundation Trust
Royal Brompton Hospital Sydney Street
London
SW3 6NP
United Kingdom

Trial participating centre

Southampton University Hospitals NHS Trust
Southampton General Hospital Tremona Road Hampshire
Southampton
SO16 6YD
United Kingdom

Trial participating centre

Papworth Hospital NHS Foundation Trust
Papworth Everard Cambridgeshire
Cambridge
CB23 3RE
United Kingdom

Trial participating centre

University College London Hospitals NHS Foundation Trust
250 Euston Road
London
NW1 2PG
United Kingdom

Trial participating centre

University Hospital Birmingham NHS Foundation Trust
Queen Elizabeth Hospital Birmingham Mindelsohn Way Edgbaston
Birmingham
B15 2GW
United Kingdom

Trial participating centre

Cardiff and Vale University Hospital of Wales
Address Eastern Avenue
Cardiff
CF14 4XW
United Kingdom

Trial participating centre

Royal Infirmary of Edinburgh NHS Lothian
Royal Infirmary of Edinburgh 51 Little France Crescent Old Dalkeith Road
Edinburgh
EH16 4SA
United Kingdom

Trial participating centre

Belfast Health and Social Care Trust
Belfast City Hospital 51 Lisburn Road
Belfast
BT9 7AB
United Kingdom

Sponsor information

Organisation

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Sponsor details

Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.newcastle-hospitals.org.uk/index.aspx

Funders

Funder type

Research council

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Plans to publish data from this study in a series of high-impact, peer reviewed articles and to present data at national and international meetings. Results of the study will also be reported to the Sponsor and Funder and will be available, if deemed appropriate, on their web sites. All manuscripts, abstracts or other modes of presentation will be reviewed by the Scientific Steering Committee and Funder (as required) prior to submission. Individuals will not be identified from any study report. Participants will be informed about the study results at the end of the study, including a lay summary.

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a publically available repository provided and hosted by the Health Information Centre (HIC), University of Dundee (https://www.dundee.ac.uk/hic/). The overall principle of the study is that it collates data from routinely collected investigations as recommended in care guidelines with participants then followed up at least annually. Data are collected on paper Case Report Form (CRF) then entered by the appropriate staff (as per each site’s delegation log) on a secure, electronic clinical database system provided and hosted by the Health Information Centre (HIC), University of Dundee (https://www.dundee.ac.uk/hic/).
Patient identifiable information leave the site always remaining contained within the secure NHS N3 network. Identifiable data will never be released to researchers. Identifiable information will be held on a system independent to the research team by a trusted third party in The Health Information Centre (HIC). HIC will host the combined dataset and use identifiable data sets to link to health data sets such as the Office for National Statistics. The BronchUK data sets, once linked to other data sets, will then be anonymised before being released to researchers. The analysis can only be performed in a HIC hosted data “safe haven”. Once the analysis is complete within the safe haven the data analysis outputs can only be exported from the safe haven after HIC have reconfirmed there are no identifiable data. No researcher will be able to access identifiable data at any point and there are two control points to ensure none is released. This follows the HIC governance framework effectively used in the past (see https://medicine.dundee.ac.uk/data-security-confidentiality).

Data are handled, computerised and stored in accordance with the Data Protection Act 1998 or relevant update. Participants are asked at baseline to agree to linking of their data based records with the Office for National Statistics and Hospital Episode Statistics. This ensures that we can capture mortality and healthcare usage as robustly as possible.

Intention to publish date

31/12/2021

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes