A randomised multi-arm, open label trial of nasal sprays and a behavioural intervention for acute respiratory illness in primary care

Paul Little*, Jane Vennik, Kate Rumsby, Beth Stuart, Taeko Becque, Michael V Moore, Nick Francis, Alastair D Hay, Theo Verheij, Katherine Bradbury, Kate Greenwell, Laura Dennison, Sian Holt, James L Denison-Day, Ben Ainsworth, James Raftery, Tammy E Thomas, Christopher C. Butler, Samantha Richards-Hall, Deb SmithHazel Patel, Samantha Williams, Jane Barnett, Karen Middleton, Sascha Miller, Sophie Johnson, Jacqui Nuttall, Fran Webley, Tracey H. Sach, Lucy Yardley, Adam WA Geraghty

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)peer-review

Abstract

Background. Limited evidence suggests that nasal sprays, or physical activity and stress-management, could limit respiratory infections. This study aimed to assess the impact on respiratory illnesses from nasal sprays or promoting physical activity and stress-management.

Methods. 13799 participants aged >=18, from 332 GP practices, with co-morbidities and/or >=3 self-reported recurrent illnesses , were randomised by online software to: i) usual care (n=3451) ii) gel-based spray (n=3448) (2 sprays per nostril, up to 6 times/day) iii) saline spray (n=3450) (same dosing), or iv) a brief behavioural website promoting physical activity and stress-management (n=3450). The sprays were relabelled. Primary outcome: respiratory illness days over 6 months. Harms: side effects, antibiotic use.

Findings. The usual care group (n=2983 analysed) had a mean of 8 self-reported illness days which was reduced in both spray groups (gel-based (n=2935) 6.5 days adjusted incidence rate ratio (IRR) 0.82, 99% CIs 0.76, 0.90, p<0.0001), Saline (n=2967) 6.4 days (IRR 0.81; 0.74,0.88, p<0.0001), behavioural website (n=2727) 7.4 days (0.97; 0.91, 1.04), p=0.46); for those reporting an illness it was 15,12,11.8 and 14 days respectively. Headache was more common with the gel-based spray (7.8%(199/2556) vs 4.8% (123/2547) usual care; risk ratio 1.61, 95% CIs 1.30 to 1.99, p<0.0001), but antibiotic use was lower for all interventions (IRRs (95% CIs) respectively 0.65 (0.50 to 0.84;p=0.001), 0.69 (0.45,0.88;p=0.003), 0.74 (0.57 to 0.94;p=0.02)).

Interpretation. Advice to use either nasal spray at the first sign of an RTI reduced illness duration and both sprays and the behavioural website reduced antibiotic use.
Original languageEnglish
Number of pages14
JournalThe Lancet Respiratory Medicine
Early online date11 Jul 2024
DOIs
Publication statusE-pub ahead of print - 11 Jul 2024

Structured keywords

  • Health and Wellbeing (Psychological Science)

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