A study to describe the clinical and biological characteristics of patients with suspected or known airways disease
| ISRCTN | ISRCTN83450779 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83450779 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 321349 |
| Protocol serial number | IRAS 321349, CPMS 55429 |
| Sponsor | North Bristol NHS Trust |
| Funders | Southmead Hospital Charity, AstraZeneca, NIHR Bristol Biomedical Research Centre |
- Submission date
- 17/04/2023
- Registration date
- 24/05/2023
- Last edited
- 17/11/2023
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
The aim of this study is to describe the clinical and biological characteristics of patients with suspected or known airways disease.
Who can participate?
Patients aged over 18 years who are referred to the complex airways service at North Bristol NHS Trust
What does the study involve?
As this study is an observational study it does not involve participants undertaking any extra visits, investigations, blood tests or medications which are not part of their usual standard care to manage their airways disease. This study will also act as a ‘platform’ study so the researchers will also ask each participant if they would like to be approached to take part in future studies based on the data collected.
What are the possible benefits and risks of participating?
As the study is only documenting data that relates to a participant's standard care therefore the researchers do not expect any added risks or burdens. Participants will be contributing to the growing knowledge in this area and improving care for patients with airways disease.
Where is the study run from?
Southmead Hospital (UK)
When is the study starting and how long is it expected to run for?
October 2022 to June 2029
Who is funding the study?
1. Bristol Biomedical Research Centre (UK)
2. The Southmead Hospital Charity Fund (UK)
3. AstraZeneca (UK)
Who is the main contact?
Dr Caitlin Morgan, caitlin.morgan@nbt.nhs.uk
Contact information
Public
Learning and Research Building
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
 ORCID ID |
0000-0001-7133-0195 |
|---|---|
| Phone | +44 (0)7739708065 |
| caitlin.morgan@nbt.nhs.uk |
Principal investigator
Learning and Research Building
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
| ORCID ID |
0000-0003-4805-5759 |
|---|---|
| Phone | +44 (0)1174147925 |
| james.dodd@nbt.nhs.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-centre longitudinal observational cohort study |
| Secondary study design | Longitudinal study |
| Study type | Participant information sheet |
| Scientific title | BRistol Evaluation of novel Airways diagnostics, Therapies & Healthcare outcomEs |
| Study acronym | BREATHE |
| Study objectives | Airways diseases have multiple phenotypes and by understanding the treatable and non-treatable traits of each phenotype, we will be able to improve clinical and patient-reported outcomes. |
| Ethics approval(s) |
Approved 12/05/2023, Westminster Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8283; westminster.rec@hra.nhs.uk), ref: 23/LO/0279 |
| Health condition(s) or problem(s) studied | Diagnosis and management of airways disease |
| Intervention | BREATHE is a single-centre, prospective longitudinal cohort study of patients who are referred to the Complex Airways Clinic at North Bristol NHS Trust (NBT). It is a platform which will include different sub-studies when they are developed in the future (with amendments reviewed by the sponsor and HRA at the time). BREATHE will record routinely collected clinical data at each stage of the multidisciplinary assessment, diagnosis and management of each patient from initial assessment until they are discharged by the service, or the study ends. The study will not include any additional investigations, questionnaires or patient visits which would not have been included as part of each patient’s routine clinical management. The landscape of airway disease management will change over the next 5 years. As such BREATHE will incorporate an adaptive study design. As novel diagnostics and therapeutics emerge, it is anticipated that changes will be made to standard care which would necessitate changes to the data that is collected. If substantial changes are made, they will be assessed for inclusion in the study and request further ethical approval if necessary. The BREATHE cohort is to be a source of potential subjects for future studies. |
| Intervention type | Other |
| Primary outcome measure(s) |
The clinical and biological characteristics of patients with suspected or known airways disease, described using standard care clinical data over a 5-year period |
| Key secondary outcome measure(s) |
1. Airways disease phenotypes and impact on disease outcomes assessed using standard care data collected over a 2-year period for each patient |
| Completion date | 01/06/2029 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | All |
| Target sample size at registration | 1500 |
| Key inclusion criteria | 1. Participant is willing and able to give informed consent for participation in the study 2. Known or suspected airways disease |
| Key exclusion criteria | 1. Participants who lack the capacity to consent for themselves 2. Aged below 16 years |
| Date of first enrolment | 15/11/2023 |
| Date of final enrolment | 01/06/2028 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 1.1 | 16/08/2023 | 19/10/2023 | No | No |
Additional files
- ISRCTN83450779_PROTOCOL_V1.1_16Aug23.pdf
- Protocol file
Editorial Notes
17/11/2023: The following changes were made to the trial record:
1. The ethics approval was added.
2. The recruitment start date was changed from 06/11/2023 to 15/11/2023.
19/10/2023: The recruitment start date was changed from 01/06/2023 to 06/11/2023. Protocol uploaded.
05/06/2023: Internal review.
21/04/2023: Trial's existence confirmed by the NIHR.
