Condition category
Respiratory
Date applied
29/09/2020
Date assigned
30/10/2020
Last edited
11/11/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 October 2024

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

Trial website

https://www.southampton.ac.uk/IDStudy

Contact information

Type

Public

Primary contact

Mrs Kate Martinson

ORCID ID

http://orcid.org/0000-0002-8573-3718

Contact details

Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
+44 (0)23 8024 1768
k.martinson@soton.ac.uk

Type

Scientific

Additional contact

Dr Jane Vennik

ORCID ID

http://orcid.org/0000-0003-4602-9805

Contact details

Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
+44 (0)23 8024 1757
j.vennik@soton.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

56474, IRAS 288431, CPMS 47080

Study information

Scientific title

Reducing respiratory infections in primary care: the Immune Defence 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

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

Study design

Multicentre open randomized controlled four-arm trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient 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

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

Phase

Not Applicable

Drug names

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 trial start date

01/09/2019

Overall trial end date

01/10/2024

Reason abandoned (if study stopped)

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

15,000

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

01/04/2023

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NIHR Wessex CRN
Unit 7, Berrywood Business Village Tollbar Way Hedge End
Southamton
SO30 2UN
United Kingdom

Trial participating centre

NIHR West of England
Whitefriars Lewins Mead
Bristol
BS1 2NT
United Kingdom

Trial participating centre

NIHR Thames Valley and South Midlands
John Radcliffe Hospital Headley Way Headington
Oxford
OX3 9DU
United Kingdom

Sponsor information

Organisation

University of Southampton

Sponsor details

Research and Innovations Services
Building 37
Highfield Campus
Southampton
SO17 1BJ
United Kingdom
+44 (0)23 8059 5058
rgoinfo@soton.ac.uk

Sponsor type

University/education

Website

http://www.southampton.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (PGfAR ref RP-PG-0218-20005)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

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 statement
The current data-sharing plans for this study are currently unknown, but will be made available at later date.

Intention to publish date

01/10/2025

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

10/11/2020: The ethics approval was added. 05/10/2020: Trial's existence confirmed by the NIHR.