Investigating the effect of the pro-inflammatory messenger interleukin-5 on antibody-secreting immune cells in the nose
| ISRCTN | ISRCTN16169610 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16169610 |
| IRAS number | 332970 |
| Secondary identifying numbers | CPMS 60796, IRAS 332970 |
- Submission date
- 15/04/2024
- Registration date
- 26/06/2024
- Last edited
- 11/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Ear, Nose and Throat
Plain English Summary
Background and study aims
In patients with asthma, nasal polyps and other similar diseases, the chemical messenger interleukin-5 (IL-5) in the body is known to have an important role in causing disease - blocking the IL-5 message improves disease control and can lead to clinical remission. IL-5 is often thought to work through its actions on a type of immune cell called eosinophils, but there is evidence it may also have important actions on other types of immune cells. In particular it appears to have actions on antibody-producing B cells. This study will investigate how IL-5 affects antibody expression by B cells in the nose using samples collected from patients undergoing removal of tissue samples from the nose for clinical reasons.
Who can participate?
Patients aged 18 years and over having surgery to remove nasal tissue for clinical reasons at relevant NHS sites
What does the study involve?
The study involves donating to the research project the nasal samples that are being removed at clinically planned surgery. The study team will also collect some clinical data, a sample of blood and a sample of the fluid inside the nose using a special sponge (certain NHS sites only).
What are the possible benefits and risks of participating?
There are minimal risks from participating as the major study activity is the donation to research of the nasal samples being removed from the nose by surgeons as part of planned clinical care. The study will not directly benefit participating patients but will help develop better treatments for patients with these conditions.
Where is the study run from?
Queen Mary University of London (UK)
When is the study starting and how long is it expected to run for?
February 2023 to January 2029
Who is funding the study?
The study was designed and is being run by academics at Queen Mary University of London but is funded as an investigator-initiated study by GlaxoSmithKline (UK)
Who is the main contact?
Dr Paul Pfeffer, Paul.pfeffer1@nhs.net
Contact information
Scientific
Barts Health NHS Trust
Dept of Respiratory Medicine
4th Floor, KGV Building
St Bartholomew's Hospital
London
EC1A 7BE
United Kingdom
| Phone | +44 (0)2034165000 |
|---|---|
| Paul.pfeffer1@nhs.net |
Study information
| Study design | Observational; Design type: Clinical Laboratory Study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | 45320_PIS_V2_09Feb24.pdf |
| Scientific title | Investigating pro-inflammatory B-lymphocyte responses in nasal polyps to interleukin-5 |
| Study acronym | BLYNI5 |
| Study hypothesis | The researchers hypothesise that anti-IL-5 monoclonal antibody therapy may have clinical action in asthma and nasal polyps through effects on other cell types than just eosinophils and potentially much of the beneficial effect of blocking IL-5 may be due to the effects on these other cell types. Specifically, they hypothesise that IL-5 exerts disease-relevant actions on antibody production by B lymphocytes in airway tissue such as nasal polyps. |
| Ethics approval(s) | Approved 06/02/2024, London - City & East Research Ethics Committee (Research Ethics Committee Centre, 2nd Floor, 2 Redman Place, Stratford, London, E20 1JQ, UK; +44 (0)207 1048171, +44 (0)207 1048134, +44 (0)207 104 8124; cityandeast.rec@hra.nhs.uk), ref: 24/PR/0073 |
| Condition | Nasal polyps |
| Intervention | Patients undergoing resection of nasal polyps and/or turbinates for clinical reasons by ENT surgeons at NHS research sites will be invited by their clinical care teams to consider donating resected nasal tissue for use in this research project. Interested patients will be given Patient Information Sheets, detailing the reason for the research and what is involved, in advance of the surgery, to enable them to give informed consent to participate. The clinical care of patients and the amount of tissue resected will not be affected by their decision on whether or not to participate in this research. Resected nasal tissue from patients who consent to participate will be used in immunological experiments as below. The clinical notes of consented participants will also be reviewed to obtain relevant past medical details - any past history of asthma, allergic or inflammatory diseases including smoking status; the reasons for the nasal surgery; any relevant medications the participant is taking; and any previous immunology test results. The patient's age, gender, ethnicity and BMI will also be recorded. When these questions are not clearly answered in the medical notes, the patient will be asked the questions. Participants may also be asked if they consent to give a sample of blood for immunological investigations and whether they are willing to give a nasal sponge/filter paper sample of their nasal lining fluid secretions (nasoabsorption sample). Participants can decline these but still give their residual nasal tissue for the study. All clinical data and laboratory investigations will be recorded in an anonymised manner to maintain patient confidentiality. All participant involvement will be limited to the single clinical care episode during which they have nasal surgery. Laboratory science immunological experiments will be conducted with the nasal tissue samples. Additionally, blood samples may be used to compare circulating cells with those present in nasal tissue. |
| Intervention type | Other |
| Primary outcome measure | The B cell receptor (BCR) (antibody immunoglobulin) repertoire of tissue-resident airway B-cells, in particular the relative expression of different immunoglobulin classes and subclasses. Measured using single-cell and bulk RNA sequencing at baseline. |
| Secondary outcome measures | BCR repertoires for convergent clonotypes evident in blood (from IDEA project) and other available BCR libraries, to assess for potential pathological clonotypes in eosinophilic airway inflammation. Measured using single-cell and bulk RNA sequencing at baseline. |
| Overall study start date | 26/02/2023 |
| Overall study end date | 11/01/2029 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 28; UK Sample Size: 28 |
| Participant inclusion criteria | 1. Patients undergoing resection of nasal tissue for clinical indications (e.g. polypectomy, turbinectomy, septoplasty, tonsilectomy) 2. Able to give consent 3. Aged 18 years and over The researchers will specifically recruit the following subgroups: 1. Patients undergoing nasal polyp resections, who are not on biologics 2. Patients undergoing nasal polyp resections, who are on anti-IL-5 biologics 3. Patients undergoing nasal operations other than polyp resection |
| Participant exclusion criteria | 1. Inability to give consent 2. Previous rituximab treatment (ever) 3. Chemotherapy with preceding 6 months 4. Cystic fibrosis 5. Pregnancy or breastfeeding 6. Known current COVID infection/TB infection |
| Recruitment start date | 14/03/2024 |
| Recruitment end date | 31/12/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
E1 1FR
United Kingdom
London
E9 6SR
United Kingdom
London
NW1 2PQ
United Kingdom
Great Maze Pond
London
SE1 9RT
United Kingdom
Sponsor information
University/education
327 Mile End Road
London
E1 4NS
England
United Kingdom
| Phone | +44 (0)2078827275 |
|---|---|
| research.governance@qmul.ac.uk | |
| Website | http://www.qmul.ac.uk/ |
"ROR" |
https://ror.org/026zzn846 |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- GlaxoSmithKline plc., GSK plc., GSK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/07/2025 |
|---|---|
| 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 | Dissemination plan as per protocol: Research findings will be disseminated by publication in peer-reviewed journals and presentation at local, national and international research meetings and conferences. Publication probably mid-2025. |
| 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 | version 2 | 09/02/2024 | 18/04/2024 | No | Yes |
| Protocol file | version 1.1 | 02/01/2024 | 18/04/2024 | No | No |
Additional files
Editorial Notes
11/03/2025: The recruitment end date was changed from 13/03/2025 to 31/12/2025.
15/04/2024: Study's existence confirmed by the NIHR.
