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

Tolerability questionnaire results for the myAIRVO 2 are shown in Table 6 . The device was 375 reasonably simple to connect at home, comfortable to wear, and acceptable with regards to the 376 amount of moisture build-up and weight of the nasal interface. It also scored favourably with 377 respect to ease of application but was found to be moderately noisy. Overall, participants 378 scored a mean (SD) of 32.4 (27.4) units on a scale of likely future use where 0 was very likely 379 and 100 was very unlikely. 380 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 This is the first study to investigate rhinothermy using the modified myAIRVO 2 device and 391 strengths include the randomised controlled design and the complete follow-up of all 392 participants. Participants in this study were recruited primarily through social media so the 393 results should be generalisable to people in the community with symptoms of the common cold. 394 395 Three main limitations apply to these results. Firstly, this study was designed as a feasibility 396 study which means that although the modified Jackson score was a pre-specified efficacy 397 outcome measure, we did not formally specify it as the primary outcome measure. Secondly, 398 due to the nature of the intervention we were unable to blind participants and investigators to 399 the allocated intervention and a future study aiming to replicate these results should explore the 400 option of sham rhinothermy. Finally, the small sample size means that although this study found 401 benefits for the new treatment the results are relatively 'fragile', in that the modified Jackson 402 score would only need to change in a small number of participants who received the 403 rhinothermy intervention to match the control group for our conclusions to be different. [ 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 participants used the myAIRVO 2 device for two hours per day on average throughout the 5 day 424 treatment period, and for 2.6 hours on the days of use. As instructed, not all participants used 425 the device late in the treatment course once their symptoms had improved. Around a third of 426 participants reduced the flow rate to 25 or 30L/min suggesting that giving participants the option 427 of reducing the flow from the initial 35L/min, or having a lower starting flow, is worthwhile. 428