Nasal sprays and a behavioural intervention for respiratory tract infections in primary care: 12-month follow-up of a randomised open-label trial
Year: 2025
Type: article
Study design: Clinical Trial
Abstract: Background The Immune Defence trial documented a short-term impact on respiratory tract infections (RTIs) for nasal sprays and a stress management and physical activity website. Aim To estimate the impact of sprays and the website after 12 months. Design and setting A four-arm parallel randomised controlled trial. Participants with comorbidities and/or ≥3 self-reported recurrent RTIs were recruited. Method Participants were randomised by online software (stratified by recurrent illness and comorbidities) to a) usual care ( n = 3451); b) Vicks First Defence (VFD) spray ( n = 3448) (two sprays/nostril, ≤6 times a day; c) isotonic saline spray ( n = 3450) (same dosing); or d) a website promoting physical activity and stress management ( n = 3450). The primary outcome was respiratory illness days. Results Usual care participants ( n = 3052) had on average 21.8 (standard deviation [SD] 35.2) illness days, reduced by VFD ( n = 3076; 17.8 [SD 27.9] days, adjusted incidence rate ratio [IRR] 0.84, 99% confidence interval [CI] = 0.79 to 0.90, P <0.0001), and saline ( n = 3142; 17.7 [SD 21.1 ] days, IRR 0.83, 99% CI = 0.78 to 0.89, P <0.0001), but not the website ( n = 2811; 19.5 [SD 31.2] days, IRR 0.94, 99% CI = 0.88 to 1.01, P = 0.03). The website reduced incident infections (adjusted risk ratio [RR] 0.96, 95% CI = 0.93 to 0.99, P = 0.006). All interventions reduced symptom severity and work days lost, both spray groups reported lower intention to consult and fewer falls, and there were fewer antibiotic courses and practice visits with saline. Among those with recurrent illness, saline had the most impact on both recurrence and symptom days (RR 0.93, 95% CI = 0.87 to 0.99 and RR 0.70, 95% CI = 0.60 to 0.82, respectively). Headaches were higher for VFD and lower for saline (7.8% and 3.4%, respectively; 4.7% usual care). Conclusion Widely available, inexpensive sprays and a website promoting self-care reduce the incidence, duration, and/or severity of RTIs and have an impact on work days lost and healthcare use.
Authors: Paul Little, Jane Vennik, Kate Rumsby, Beth Stuart, Taeko Becque, Michael Moore, Nick Francis, Alastair D Hay, Theo Verheij, Katherine Bradbury, Kate Greenwell, Laura Dennison, Sian Holt, James Denison-Day, Ben Ainsworth, James Raftery, Tammy Thomas, Christopher C Butler, Samantha Richards-Hall, Debs Smith, Hazel Patel, Samantha Williams, Jane Barnett, Karen Middleton, Sascha Miller, Sophie Johnson, Jacqui Nuttall, Fran Webley, Tracey Sach, Lucy Yardley, Adam WA Geraghty
Language: English
Subfield: Emergency Medical Services
Field: Health Professions
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W4415517056
FWCI:
Cites:
Cited by:
Related to: