Randomised controlled trial of rhinothermy for treatment of the common cold: a feasibility study. Issue 3 (27th March 2018)

• Record Type: Journal Article
• Authors: Hei, Susanne van de; McKinstry, Steven; Bardsley, George; Weatherall, Mark; Beasley, Richard; Fingleton, James
• Is Part Of: BMJ open. Volume 8:Issue 3(2018)
• Publication Date: 2018-03-27
• Subjects: infectious diseases -- virology -- clinical trials -- respiratory medicine (see thoracic medicine); Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2017-019350
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Objective: To determine the feasibility of a randomised controlled trial (RCT) of rhinothermy for the common cold. Design: Open label, randomised, controlled feasibility study. Setting: Single-centre research institute in New Zealand recruiting participants from the community. Participants: 30 adult participants with symptoms of a common cold, presenting within 48 hours of the onset of symptoms. Interventions: Participants were randomly assigned 2:1 to receive either 35 L/min of 100% humidified air at 41°C via high flow nasal cannulae, 2 hours per day for up to 5 days (rhinothermy), or vitamin C 250 mg daily for 5 days (control). Primary and secondary outcome measures: The primary outcome was the proportion of screened candidates who were randomised. Secondary outcomes included: proportion of randomised participants who completed the study; modified Jackson scores from randomisation to 10 days after initiation of randomised regimen; time until feeling 'a lot better' compared with study entry; time until resolution of symptoms or symptom score at 10 days postrandomisation; proportion of organisms identified by PCR analysis of nasal swabs taken at baseline; the patterns of use of the rhinothermy device; estimated adherence of the control group; and rhinothermy device tolerability. Results: In all 30/79 (38%, 95% CI 27% to 50%) of potential participants screened for eligibility were randomised. Rhinothermy was well tolerated, and all randomised participants completed the study (100%, 95% CI 88% to 100%). The reduction from baseline in the modified Jackson score was greater with rhinothermy compared with control at days 2, 3, 4, 5 and 6, with the maximum difference at day 4 (−6.4, 95% CI −9.4 to −3.3). The substantial clinical benefit threshold for modified Jackson score was a 5-unit change. Conclusions: This study shows that an RCT of rhinothermy compared with low-dose vitamin C in the treatment of the common cold is feasible. Trial registration number: ACTRN12616000470493; Results.