Protocol for a randomised, single-blind, two-arm, parallel-group controlled trial of the efficacy of rhinothermy delivered by nasal high flow therapy in the treatment of the common cold

Bird, Grace; Braithwaite, Irene; Harper, James; McKinstry, Steven; Koorevaar, Iris; Fingleton, James; Semprini, Alex; Dilcher, Meik; Jennings, Lance; Weatherall, Mark; Beasley, Richard

Nasopharyngeal specimens will be obtained during the screening visit using Copan's flocked swabs (FLOQSwabs™) . These specimens will be tested for the presence of influenza type A or B virus nucleic acid using the GeneXpert® Xpress Flu/RSV point-of-care test (Cepheid, Ca, USA). The sensitivity and specificity of real-time PCR using the GeneXpert® Xpress Flu/RSV point-of-care test, for the rapid diagnosis of influenza virus has been reported as 97.8% and 100% respectively. [21] Nasopharyngeal specimens obtained from enrolled participants will also be sent to Canterbury A permuted block randomisation method stratified by duration of illness, lesser versus greater than or equal to one day, will be used to allocate participants to either treatment arm. The computergenerated sequence will be supplied by the study statistician, independent of the investigators. The eCRF system will conceal the allocations and will release a participant's randomisation outcome at the time of randomisation. The randomisation schedule will only be accessed by the study statistician and the eCRF provider; study staff will not have access to the randomisation schedule.