A comprehensive disease characterisation study in adult bronchiectasis
| ISRCTN | ISRCTN15320623 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15320623 |
| IRAS number | 292518 |
| Secondary identifying numbers | 1.006.21, IRAS 292518, CPMS 52829 |
- Submission date
- 18/04/2023
- Registration date
- 27/04/2023
- Last edited
- 19/07/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Respiratory
Plain English Summary
Background and study aims
Bronchiectasis is a common lung disease which causes your airways to become filled with mucus (sputum). This leads to frequent chest infections and breathlessness among other problems. Doctors and scientists are still learning how bronchiectasis affects the lungs and need to develop more effective treatments to manage the condition.
This study will complete a thorough range of tests on people, both with and without bronchiectasis, allowing for the most detailed mapping ever of the condition. This will enable researchers to see how bronchiectasis affects people and what differences there are between the two groups.
Who can participate?
Adults aged 18 years and over with a diagnosis of bronchiectasis and healthy controls living within the NHS Tayside boundary
What does the study involve?
Tests will look at the lungs to see how they are affected by bronchiectasis. These tests will include a CT scan, lung function tests and a bronchoscopy with lung biopsies. The researchers wish to study a group of 80 people who have bronchiectasis and a group of 40 people with no bronchiectasis in order to compare them.
What are the possible benefits and risks of participating?
There will be no direct benefit to participants. However, the outcome of the study could help the care of patients in the future. Some of the procedures might be a little uncomfortable, but discomfort and risks are minimised by the use of experienced clinical staff.
Where is the study run from?
University of Dundee Medical School, Ninewells Hospital Dundee (UK)
When is the study starting and how long is it expected to run for?
August 2020 to July 2025
Who is funding the study?
AstraZeneca (UK)
Who is the main contact?
Prof. James Chalmers, j.chalmers@dundee.ac.uk
Contact information
Principal Investigator
Dept.of Respiratory Medicine
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
 ORCID ID |
0000-0001-5514-7868 |
|---|---|
| Phone | +44 (0)1382383642 |
| j.chalmers@dundee.ac.uk |
Study information
| Study design | Single-centre prospective observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital, University/medical school/dental school |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Bronchiectasis Research Into Leukocyte biology and Lung Infections to Accelerate New Therapies (BRILLIANT) |
| Study acronym | BRILLIANT |
| Study hypothesis | The overall objective of the study is to identify clinically relevant endotypes (subgroups of patients defined by distinct biological mechanisms) by integrating clinical, inflammatory, microbiological, mucociliary and pathological assessments. |
| Ethics approval(s) | Approved 09/08/2021, East of Scotland Research Ethics Service (EoSRES, Tayside Medical Science Centre, Residency Block Level 3, George Pirie Way, Ninewells Hospital and Medical School, Dundee DD1 9SY, UK; +44 1382 383848; tay.eosres@nhs.scot), ref: 21/ES/0064 |
| Condition | Bronchiectasis |
| Intervention | Tests will look at the lungs to see how they are affected by bronchiectasis. These tests will include a CT scan, lung function tests and a bronchoscopy with lung biopsies. The researchers wish to study a group of 80 people who have bronchiectasis and a group of 40 people with no bronchiectasis in order to compare them. |
| Intervention type | Other |
| Primary outcome measure | The molecular endotypes of bronchiectasis during stable disease, determining by integrating data from multiple sources including clinical, inflammatory, microbiological, mucociliary and pathological assessments to identify candidate endotypes. Cross-sectional at baseline (single timepoint). |
| Secondary outcome measures | Biological characteristics measured at a single time point: 1.1. Inflammatory markers – including blood eosinophils, serum biomarkers 1.2. Microbiology – including BAL culture and sequencing 1.3. Lung physiology – including Spirometry and lung function testing |
| Overall study start date | 16/08/2020 |
| Overall study end date | 01/07/2025 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 |
| Participant inclusion criteria | Bronchiectasis cohort: 1. Age >18 years 2. Bronchiectasis diagnosed by CT scan 3. Symptoms consistent with bronchiectasis: cough, sputum and/or frequent respiratory tract infections 4. Clinically stable defined by the absence of antibiotic therapy in the previous 4 weeks Healthy control cohort: 1. Age >18 years |
| Participant exclusion criteria | Bronchiectasis cohort: 1. A primary diagnosis of asthma or COPD (secondary diagnoses and individuals with historical misdiagnosis will be permitted) 2. Immunodeficiency requiring immunoglobulin replacement therapy 3. Active allergic bronchopulmonary aspergillosis (defined by receipt of oral corticosteroids or anti-fungal therapy) 4. Active tuberculosis 5. Traction bronchiectasis due to interstitial lung disease 6. Active SARS-CoV-2 infection or contact with a confirmed case in the previous 14 days 7. Active malignancy excluding non-melanoma skin cancer 8. Antibiotic treatment for an acute respiratory tract infection or exacerbation in the previous 4 weeks 9. Treatment with anticoagulants 10. Any contraindication to study procedures including bronchoscopy 11. Current smoking or smoking in the preceding 3 months Healthy control cohort: 1. Any respiratory diagnosis (asthma, COPD, bronchiectasis, pulmonary fibrosis or any other chronic respiratory condition requiring regular treatment) 2. Inflammatory conditions including rheumatoid arthritis, inflammatory bowel disease, and any other connective tissue disease 3. Active SARS-CoV-2 infection or contact with a confirmed case in the previous 14 days 4. Active malignancy excluding non-melanoma skin cancer 5. Antibiotic treatment for an acute respiratory tract infection in the previous 4 weeks 6. Any contraindication to study procedures including bronchoscopy 7. Current smoking or smoking in the preceding 3 months 8. Upper respiratory tract infection in the previous 4 weeks or current sinusitis 9. Treatment with anticoagulants |
| Recruitment start date | 16/08/2022 |
| Recruitment end date | 01/07/2025 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Dundee
DD1 9SY
United Kingdom
Sponsor information
University/education
Tayside Medical Science Centre (TASC)
NHS Tayside Ninewells Hospital and Medical School.
Dundee
DD1 9SY
Scotland
United Kingdom
| Phone | +44 (0)1382 383945 |
|---|---|
| tascgovernance@dundee.ac.uk | |
| Website | https://www.dundee.ac.uk/tasc |
"ROR" |
https://ror.org/03h2bxq36 |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- AstraZeneca PLC, Pearl Therapeutics
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/07/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| 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? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
19/07/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 01/07/2024 to 01/07/2025.
2. The overall study end date was changed from 01/07/2024 to 01/07/2025.
3. The intention to publish date was changed from 01/07/2025 to 01/07/2026.
02/05/2023: Internal review.
27/04/2023: Trial's existence confirmed by East of Scotland Research Ethics Service
