Immune Defence Study
Research type
Research Study
Full title
Reducing recurrent respiratory infections in primary care: The Immune Defence Study
IRAS ID
288431
Contact name
Paul Little
Contact email
Sponsor organisation
University of Southampton
ISRCTN Number
ISRCTN17936080
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
A range of viruses circulate each winter and cause respiratory infections (RTIs) (the viruses that causes colds, sore throats, sinus, chest or ear infections, flu). These can lead to people being off work, to seeking help from the NHS, and to be admitted to hospital in winter months. The combined effect of both the normal winter viruses (and also the COVID virus in the current pandemic) are likely to cause 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, reduce how severe illnesses are and how long they last.
The NIHR has funded the RECUR Programme to develop and trial interventions to find out if they reduce the incidence of infections. We 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. We have involved both a range of patients and also patient representatives as collaborators in the design of our study to help ensure the procedures are relevant and appropriate to patients. We had planned a large feasibility study this year in the 2020-21 winter season, and a full trial in a ‘normal’ year in the 2021-2023 winter seasons. However, the stage of development this year and our previous experience of running large similar trials suggests that instead of the feasibility study we can move to a larger full trial straight away among at risk groups so that we generate a sizeable sample during the pandemic.
This study will involve approximately 200 GP practices and up to 15000 patients who are at risk from respiratory infections. Patients 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 randomised to one of the following groups for 12 months: i) A microgel nasal spray ii) Saline nasal spray, iii) Getting Active and Reducing Stress or iv) Usual Care. Participants will be asked to complete monthly questionnaires for 6 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.REC name
South East Scotland REC 01
REC reference
20/SS/0102
Date of REC Opinion
23 Oct 2020
REC opinion
Further Information Favourable Opinion