3TR-ABC multi-scale multiomic analysis of mild/moderate asthma and healthy controls
| ISRCTN | ISRCTN16417487 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16417487 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 323812 |
| Protocol serial number | 0902, IRAS 323812, CPMS 55639 |
| Sponsor | University of Leicester |
| Funder | Innovative Medicines Initiative |
- Submission date
- 02/02/2024
- Registration date
- 06/02/2024
- Last edited
- 07/05/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Asthma affects over 350 million people in the world. Approximately 5-10% of people with asthma have severe disease. Asthma is a lung disease associated with inflammation (swelling) of the airways. Certain proteins made by the body, called interleukins, can make this inflammation worse. White blood cells (called eosinophils) are also involved in the inflammation of the airways. In recent years, new treatment options have been developed. These new treatments, called biological drugs, have been shown to improve quality of life and reduce the use of high doses of steroids which are heavy in side effects. The challenge with biological drugs is that not all patients benefit or fully benefit from the treatment. Thus, there is a need for a better understanding of which patients will and will not benefit from biological drugs.
As part of this sub-study, people with mild/moderate asthma and healthy people with or without an underlying lung disease will be included as reference groups or ‘controls’ and will undergo the same baseline visit as patients with severe asthma. It is important to have ‘controls’ so that researchers can compare different factors with the investigation population of the study (i.e. in this study, patients with severe asthma). By doing this sub-study we hope to be able to obtain information that may help to improve asthma treatment in the future.
Who can participate?
Adults aged 18 years and over with mild/moderate asthma, and healthy people with or without an underlying lung disease.
What does the study involve?
Participants with mild/moderate asthma and healthy people with or without an underlying lung disease will be included as reference groups or ‘controls’ and will undergo the same baseline visit as patients with severe asthma. It is important to have ‘controls’ so that researchers can compare different factors with the investigation population of the study (i.e. in this study, patients with severe asthma).
What are the possible benefits and risks of participating?
There is no guarantee that participants will receive any benefit from this study, and taking part in this study may or may not improve their asthma (where applicable). Information from this study may help asthma treatment in the future.
There are possible risks, disadvantages and inconveniences with any research study. The individual risks to each procedure and investigation are described fully earlier on in the information sheet. Consider these carefully before agreeing to take part in this study. As part of the sub-study, participants will be asked to attend their local research site to complete the baseline visit. The study visit can last approximately 3 to 4.5 hours, however it may be performed over several days if they wish. Participants will also have more tests and procedures than they normally would if they take part in the study.
Where is the study run from?
This is a research project organised by the NIHR Leicester Biomedical Research Centre – Respiratory at Glenfield Hospital. This study is part of a larger programme of studies, called 3TR. 3TR is a European research group aimed at improving the treatment of asthma and COPD. This study is being conducted by a group of clinical and academic experts from UK universities and Europe, together with pharmaceutical companies who have an interest in asthma. The sponsor of the study is the University of Leicester (UK). The sponsor is the organisation responsible for ensuring that the study is carried out correctly.
When is the study starting and how long is it expected to run for?
March 2023 to December 2026
Who is funding the study?
Innovative Medicines Initiative (Belgium)
Who is the main contact?
1. UK project management team, abc-3tr@leicester.ac.uk
2. Prof Chris Brightling, ceb17@leicester.ac.uk
Contact information
Public
Department of Respiratory Sciences
University of Leicester
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
| Phone | +44 (0)116 252 2893 |
|---|---|
| abc-3tr@leicester.ac.uk |
Scientific, Principal investigator
Department of Respiratory Sciences
University of Leicester
NIHR Leicester Biomedical Research Centre – Respiratory
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
 ORCID ID |
0000-0002-9345-4903 |
|---|---|
| Phone | +44 (0)116 250 2704 |
| ceb17@leicester.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Multi-centre multi-national observational study |
| Secondary study design | Longitudinal study |
| Study type | Participant information sheet |
| Scientific title | 3TR-ABC multiomics in asthma and healthy controls |
| Study acronym | 3TR-ABC multiomics |
| Study objectives | Asthma remission following treatment with biologics is related to baseline phenotype and biomarker(s) or early changes in biomarkers. Patients with mild/moderate controlled asthma and healthy controls will act as a reference population for baseline biomarkers of asthma remission. |
| Ethics approval(s) |
Approved 18/12/2023, Nottingham 1 Research Ethics Committee (Health Research Authority, 2nd Floor, Equinox House, City link, Nottingham, NG2 4LA, United Kingdom; +44 (0)2071048115; Nottingham1.rec@hra.nhs.uk), ref: 23/EM/0072 |
| Health condition(s) or problem(s) studied | Mild/moderate asthma and healthy volunteers |
| Intervention | Patients with mild/moderate controlled asthma and healthy individuals will be included as reference (control) groups and will undergo the same baseline visit as patients with severe asthma. Data from the study will be used as a comparison for the TezeBIO study (https://www.isrctn.com/ISRCTN75982397), DupiBIO study (https://www.isrctn.com/ISRCTN68147929), and MepoBIO study (https://www.isrctn.com/ISRCTN47298476). Up to 50 healthy controls (age, sex, and smoking history matched) and 50 mild/moderate asthma controls (minimum matched according to age, sex, and smoking history) will be recruited. This study is aligned with the 3TR (taxonomy, treatment, targets and remission) EU-IMI consortium asthma biologics cohort (3TR-ABC). |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Adequacy of asthma control and change in asthma control measured using the Asthma Control Questionnaire 5 Questions (ACQ5) <1.5, assessed at 1 year |
| Key secondary outcome measure(s) |
1. Patient-reported outcomes (* indicates only in mild/moderate asthma controls): |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | Mild/moderate asthma controls 1. Adult (≥18 years old) 2. Diagnosed with mild/moderate controlled asthma: 2.1 Low/medium dose of ICS/LABA +/- LTRA 2.2 ACQ < 1.5 2.3 Markers of T2 inflammation (B-eos ≥ 0.15 actual or ≥ 0.30 the last year or Sputum eos ≥ 3%, FeNO ≥ 25, allergens positivity) 2.4 Markers of T2 low inflammation (B-eos < 0.15 actual or < 0.30 the last year of sputum eos < 3%, FeNO < 25, allergens negativity) 2.5 No exacerbations in the past 12 months 2.6 No need for prednisolone treatment 2.7 Not a direct candidate for biologic therapy 3. Be able to give valid written consent, and compliant with study procedures and study visits. Healthy controls 1. Adult (≥18 years old) 2. Healthy: 2.1 No current medication/therapy for autoimmune, inflammatory, or allergic diseases 2.2 No history of asthma or respiratory symptoms 2.3 No history of allergies 2.4 No upper or lower respiratory infections in the past 4 weeks 3. Be able to give valid written consent, compliant with study procedures and study visits |
| Key exclusion criteria | Mild/moderate asthma controls 1. Unable to understand written information due to language barriers. 2. Unable to give informed consent, i.e., patients who are incapable. 3. Unable to complete study visits. Healthy controls 1. Unable to understand written information due to language barriers. 2. Unable to give informed consent, i.e., patients who are incapable. 3. Unable to complete study visits. |
| Date of first enrolment | 31/08/2023 |
| Date of final enrolment | 31/12/2025 |
Locations
Countries of recruitment
- United Kingdom
- England
- Scotland
Study participating centres
Groby Rd
Leicester
LE3 9QP
United Kingdom
Gartnavel Royal Hospital
1055 Great Western Road Glasgow
Glasgow
G12 0XH
United Kingdom
Tremona Road
Southampton
SO16 6YD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Published as a supplement to the results publication |
| IPD sharing plan | The datasets generated and/or analysed during this study will be included in the subsequent results publication. |
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 |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
07/05/2025: The following changes were made:
1. The recruitment end date was changed from 31/05/2025 to 31/12/2025.
2. The overall end date was changed from 31/08/2026 to 31/12/2026.
28/02/2025: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2024 to 31/05/2025.
2. The overall end date was changed from 31/03/2026 to 31/08/2026.
3. The intention to publish date was changed from 31/03/2027 to 31/08/2028.
4. The plain English summary was updated to reflect these changes.
07/08/2024: The recruitment end date was changed from 31/08/2024 to 31/12/2024.
04/03/2024: Internal review.
05/02/2024: Study's existence confirmed by Health Research Authority.
