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12 month follow-up of a randomised open label trial of nasal sprays and a behavioural intervention for respiratory tract infections (RTIs) in primary care

Abstract:
BACKGROUND: The Immune defence trial documented short term impacts on 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: Four arm parallel randomised controlled trial Setting. Participants with co-morbidities and/or >=3 self-reported recurrent illnesses recruited by mailed invitation. Methods Participants were randomised by online software (stratified by recurrent illness and comorbidities) to i) usual care (n=3451) ii) Vick's First-Defence (VFD) spray (n=3448) (2 sprays/nostril, <=6x/day) iii) isotonic saline spray (n=3450) (same dosing) or iv) a website promoting physical activity and stress-management (n=3450). PRIMARY OUTCOME: respiratory illness days. FINDINGS: Usual care participants (n=3051) had on average 22 illness days, reduced by VFD ((n=3076; 18 days, adjusted incidence rate ratio (IRR) 0.84, 99% CIs 0.79,0.90; p<0.0001), and saline (n=3142; 18 days, IRR 0.83; 0.78,0.89; p<0.0001), but not the website (n=2811; 20 days, IRR 0.94;0.88,1.01, p=0.03)). The website reduced incident infections (0.96,0.93 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 (respectively 0.93 (0.87,0.99), 0.70 (0.60,0.82)). Headache were higher for VFD and lower for saline (7.8%, 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 impact work-days lost and healthcare use.
Publication status:
Published
Peer review status:
Peer reviewed

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Publisher copy:
10.3399/bjgp.2025.0269

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Author
ORCID:
0000-0003-3664-1873
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ORCID:
0000-0003-4602-9805
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ORCID:
0000-0002-8573-3718
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ORCID:
0000-0001-5432-7437
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ORCID:
0000-0002-0362-3794


Publisher:
Royal College of General Practitioners
Journal:
British Journal of General Practice More from this journal
Pages:
BJGP.2025.0269-BJGP.2025.0269
Publication date:
2025-10-24
DOI:
EISSN:
1478-5242
ISSN:
0960-1643


Language:
English
Pubs id:
2309546
UUID:
uuid_e9a00474-c581-4318-978d-0b279c116af0
Local pid:
pubs:2309546
Source identifiers:
W4415517056
Deposit date:
2025-11-08
ARK identifier:
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