Dataset Information

Rhinothermy delivered by nasal high flow therapy in the treatment of the common cold: a randomised controlled trial.

ABSTRACT:

Background

The common cold is the most common infectious disease affecting humans and has a substantial economic impact on society. Human rhinoviruses, which cause almost two-thirds of colds, have demonstrated temperature-dependent replication which is optimal between 33°C and 35°C.

Methods

This randomised, single-blind, parallel-group trial completed at a single-centre in New Zealand, recruited 170 participants aged 18-75 years (mean age 27.5 years) who were within 48 hours of common cold symptom onset and had a symptom score (the Modified Jackson Score (MJS)) ≥7 and a negative point-of-care test for influenza. Participants were blinded to the intervention and randomised (1:1) to 5 days of either nasal high flow rhinothermy (rNHF) (100% humidified air delivered at 35 L/min and 41°C for 2 hours daily) (n=85) or 'sham' rhinothermy (100% humidified air delivered at 10 L/min and 31°C for 10 min daily) (n=85) and completed daily symptom diaries, which included the MJS, for 14 days, to investigate whether rNHF reduced common cold symptom severity and duration compared with 'sham' rhinothermy.

Results

An intention-to-treat superiority analysis included all randomised participants and showed no difference between treatment groups for the primary outcome, the day 4 MJS analysed by analysis of covariance: mean (SD) 6.33 (3.97) for rNHF vs 5.8 (3.15) for 'sham'; estimated difference (95% CI) 0.37 (-0.69 to 1.42), p=0.49. There was no difference in time until resolution of symptoms: mean (SD) 5.96 (4.47) days for rNHF vs 6.42 (4.09) days for 'sham'; estimated difference (95% CI) 1.02 (0.75 to 1.38), p=0.91. There were no serious adverse events related to the study treatments.

Conclusions

This well-powered, single-blind randomised controlled trial does not provide evidence that 5 days of rNHF (100% humidified air heated to 41°C delivered at 35 L/min for 2 hours daily) reduces common cold symptom severity or duration. However, investigation of rNHF in the treatment of influenza is warranted.

Trial registration number

ACTRN12617001340325.

SUBMITTER: Bird G

PROVIDER: S-EPMC8634207 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectiveTo determine the feasibility of a randomised controlled trial (RCT) of rhinothermy for the common cold.DesignOpen label, randomised, controlled feasibility study.SettingSingle-centre research institute in New Zealand recruiting participants from the community.Participants30 adult participants with symptoms of a common cold, presenting within 48?hours of the onset of symptoms.InterventionsParticipants 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 measuresThe 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.ResultsIn 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.ConclusionsThis study shows that an RCT of rhinothermy compared with low-dose vitamin C in the treatment of the common cold is feasible.Trial registration numberACTRN12616000470493; Results.

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