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

van de Hei, Susanne; McKinstry, Steven; Bardsley, George; Weatherall, Mark; Beasley, Richard; Fingleton, James

that our 147 findings are generalisable to symptomatic common colds, and not restricted to those with positive 148 virus detection. It also suggests that the efficacy may also relate to non-temperature related anti-149 viral effects, such as humidification of the airways and enhanced mucociliary clearance. This study shows that an RCT of rhinothermy with the modified myAIRVO 2 device is feasible, 154 that rhinothermy is well tolerated, and that the estimated change denoting substantial clinical 155 benefit for the modified Jackson score is a five unit change. Compared with vitamin C, 156 rhinothermy improves symptoms of the common cold by at least the substantial clinical benefit 157 threshold between days 3 and 5. These efficacy findings now require replication in a larger study 158 of common colds. Investigation of the efficacy of rhinothermy in the treatment of influenza is also 159 a priority, in view of the temperature-sensitivity of influenza viruses, [39] [40] [41] Results: In all 30/79 (38%, 95% CI 27 to 50) of potential participants screened for eligibility 44 were randomised. Rhinothermy was well tolerated and all randomised participants completed 45 the study (100%, 95% CI 88 to 100%). The reduction from baseline in the modified Jackson 46 score was significantly greater with rhinothermy compared with control at days 2, 3, 4, 5, and 6, 47 with the maximum difference at day 4 (-6.4, 95%CI -9.4 to -3.3). The substantial clinical benefit 48 threshold for modified Jackson score was a 5 unit change. 49