Evaluating nasal sprays and physical activity/stress management in reducing respiratory infections in primary care
| ISRCTN | ISRCTN17936080 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17936080 |
| IRAS number | 288431 |
| Secondary identifying numbers | UoS 56474, CPMS 47080 |
- Submission date
- 29/09/2020
- Registration date
- 30/10/2020
- Last edited
- 08/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Respiratory
Plain English Summary
Background and study aims
A range of viruses circulate each winter and cause respiratory infections (RTIs) (the viruses that cause colds, sore throats, sinus, chest or ear infections, flu). These can lead to people being off work, seeking help from the NHS, and being admitted to hospital in the winter months. The combined effect of both the normal winter viruses (and also the COVID-19 virus in the current pandemic) are likely to cause a major problem for the NHS not only during the coming 2020-21 winter season but in subsequent years. There is promising evidence that using nasal sprays, or alternatively reducing stress and increasing exercise, could help people’s immune defences, reduce the number of people getting infections, and reduce how severe illnesses are and how long they last. The NIHR has funded the RECUR Programme to develop and test interventions to find out if they reduce the incidence of infections. The researchers have developed a website called Immune Defence which will help us to see if using nasal sprays or getting more physically active and reducing stress can help people get fewer and less severe infections.
Who can participate?
This study will involve approximately 200 GP practices and up to 15,000 patients who are at risk from respiratory infections.
What does the study involve?
Participants will be invited to take part in the study through invitation letters from their GP surgery. Those who are interested in taking part will be asked to register online and to answer some questions to ensure the study is right for them. Eligible patients will be randomly allocated to one of the following treatments for 12 months: a microgel nasal spray, a saline nasal spray, support for getting active and reducing stress, or usual care for infections. Participants will be asked to complete monthly questionnaires for 12 months and more detailed questionnaires at 3, 6 and 12 months about any infections and about their general health. Patients happy to do so will complete a daily diary of symptoms if they do become unwell to give a more detailed understanding of the course of each illness. A sample of patients and healthcare practitioners will be asked to take part in a telephone interview about their experiences of taking part in the study.
What are the possible benefits and risks of participating?
Using nasal sprays or being more active and reducing stress may help participants get fewer infections. Participation in the study will help researchers find out if any of the treatments make a difference during the time of the COVID-19 pandemic. It will also help researchers plan more studies in the future to find out which treatment is best to reduce the number of cold and flu infections that people get during ‘normal’ winters. The main disadvantage is that it will take time to complete the questionnaires. Very rarely the microgel nasal spray can cause dryness in the nose resulting in a nosebleed.
Where is the study run from?
University of Southampton (UK)
When is the study starting and when is it expected to run from?
September 2019 to March 2025
Who is funding the study?
NIHR-Programme Grants for Applied Research (PGfAR) (NIHR) (UK)
Who is the main contact?
Dr Jane Vennik
j.vennik@soton.ac.uk
Contact information
Public
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
 ORCID ID |
0000-0002-8573-3718 |
|---|---|
| Phone | +44 (0)23 8024 1768 |
| k.martinson@soton.ac.uk |
Scientific
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
| ORCID ID |
0000-0003-4602-9805 |
|---|---|
| Phone | +44 (0)23 8024 1757 |
| j.vennik@soton.ac.uk |
Study information
| Study design | Multicentre open randomized controlled four-arm trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | The participant information sheet is available from the study website (https://www.southampton.ac.uk/IDStudy) or by contacting the study team on IDstudy@soton.ac.uk |
| Scientific title | Reducing respiratory infections in primary care: the Immune Defence Study |
| Study acronym | Immune Defence |
| Study hypothesis | This study will estimate the effectiveness and cost-effectiveness of commonly available nasal sprays and a brief physical activity and stress management intervention in preventing and reducing the incidence, severity and duration of RTIs among patient at risk of serious infection in the COVID-19 pandemic |
| Ethics approval(s) | Approved 23/10/2020, South East Scotland REC 01 (South East Scotland Research Ethics Committee 1, 2nd Floor, Waverley Gate, Edinburgh, EH1 3EG, UK; +44 (0)7814 764 241; Sandra.Wyllie@nhslothian.scot.nhs.uk), REC ref: 20/SS/0102 |
| Condition | Respiratory tract infections |
| Intervention | Participants will be invited to take part in the study through invitation letters from their GP surgery. Those who are interested in taking part will be asked to register online and to answer some questions to ensure the study is right for them. Participants will be randomized to one of four interventions for 12 months: 1. Microgel nasal spray (medical device) 2. Saline nasal spray (medical device) 3. Support for physical activity and stress management (behavioural intervention) 4. Usual care for infections Participants will be asked to complete monthly questionnaires for 12 months, and more detailed questionnaires at 3, 6 and 12 months about any infections and about their general health. Patients happy to do so will complete a daily diary of symptoms if they do become unwell to give a more detailed understanding of the course of each illness. A sample of patients and healthcare practitioners will be asked to take part in a telephone interview about their experiences of taking part in the trial. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Microgel nasal spray, saline nasal spray |
| Primary outcome measure | Duration of illness due to respiratory tract infections (RTIs) measured using patient report of total days with symptoms over 6 months (data collected monthly, at 3, 6 and 12 months) |
| Secondary outcome measures | 1. The incidence of respiratory tract infections measured using patient report of the total number of infections over 6 months (data collected monthly, at 3, 6 and 12 months) 2. Number of health service contacts measured using patient report over 6 months (data collected monthly, at 3, 6 and 12 months) 3. Number of admissions to hospital in total and for respiratory tract infections using patient report and GP report (data collected monthly, at 3, 6 and 12 months) and medical notes review (12 months) 4. Use of health service resource (to estimate the cost-effectiveness of each intervention) measured by patient report (data collected monthly, at 3, 6 and 12 months) and medical notes review (12 months) 5. Use of antibiotics for respiratory tract infections measured by patient report (data collected monthly, at 3, 6 and 12 months) and medical notes review (12 months) 6. The incidence of COVID-like infections (during winters when COVID is circulating) measured using patient report of the total number of infections over 6 months (data collected monthly and at 6 months) 7. The incidence of confirmed COVID infections measured through patient report as part of normal management (data collected monthly, at 3, 6 and 12 months) and medical notes review (12 months) |
| Overall study start date | 01/09/2019 |
| Overall study end date | 31/03/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 15,000 |
| Total final enrolment | 13799 |
| Participant inclusion criteria | 1. Patients aged ≥18 years with a risk factor: 1.1. Known weakened immune system due to a serious illness or medication (e.g. chemotherapy) 1.2. Known heart disease 1.3. Known asthma or lung disease 1.4. Known diabetes 1.5. Known mild hepatic impairment 1.6. Known stroke or neurological problem 1.7. Obesity (BMI >30) 1.8. Patients with ≥3 episodes of an RTI in the last year 2. Patients aged ≥65 3. Have access to the internet |
| Participant exclusion criteria | 1. Terminal illness/palliative care 2. Living with dementia 3. Living in residential care 4. Pregnancy or breastfeeding 5. Regular use of nasal sprays for respiratory infection control in the last 6 months 6. Allergy to nasal sprays 7. Living in the same household as another participant 8. Previously involved in RECUR programme development work |
| Recruitment start date | 01/11/2020 |
| Recruitment end date | 01/05/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Tollbar Way
Hedge End
Southamton
SO30 2UN
United Kingdom
Lewins Mead
Bristol
BS1 2NT
United Kingdom
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Sponsor information
University/education
Research and Innovations Services
Building 37, Highfield Campus
Southampton
SO17 1BJ
England
United Kingdom
| Phone | +44 (0)23 8059 5058 |
|---|---|
| rgoinfo@soton.ac.uk | |
| Website | http://www.southampton.ac.uk/ |
"ROR" |
https://ror.org/01ryk1543 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/10/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. The researchers will make the REC-approved protocol available on their trial website. |
| IPD sharing plan | At the end of the study anonymous questionnaire data will be deposited in a secure data archive which will be made available to researchers at University of Southampton for secondary data analysis. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol article | 14/07/2023 | 17/07/2023 | Yes | No | |
| Protocol file | version 8.2 | 18/09/2023 | 06/10/2023 | No | No |
| Statistical Analysis Plan | version 2 | 19/10/2023 | 14/06/2024 | No | No |
| Results article | 11/07/2024 | 16/07/2024 | Yes | No |
Additional files
Editorial Notes
08/10/2024: The overall end date was changed from 01/10/2024 to 31/03/2025.
16/07/2024: Publication reference added.
14/06/2024: Uploaded statistical analysis plan.
06/10/2023: Uploaded protocol (not peer-reviewed).
17/07/2023: Publication reference added.
22/05/2023: The total final enrolment was added.
25/04/2023: The IPD sharing statement and summary have been added.
17/04/2023: The recruitment end date has been changed from 01/04/2023 to 01/05/2023.
10/11/2020: The ethics approval was added.
05/10/2020: Trial's existence confirmed by the NIHR.
