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Randomised controlled trial of rhinothermy for treatment of the common cold: a feasibility study.


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.

SUBMITTER: Hei SV 

PROVIDER: S-EPMC5875674 | BioStudies | 2018-01-01T00:00:00Z

REPOSITORIES: biostudies

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