Selected article for: "low dose and randomised feasibility study"
Author: van de Hei, Susanne; McKinstry, Steven; Bardsley, George; Weatherall, Mark; Beasley, Richard; Fingleton, James
Title: Randomised controlled trial of rhinothermy for treatment of the common cold: a feasibility study
  • Document date: 2018_3_27
    • ID: iys2ezkd_58
    Snippet: Our study has also been informative in terms of the likely number of participants required in a 430 RCT. We have estimated the change in modified Jackson score which denotes substantial 431 This study shows that an RCT of rhinothermy with the modified myAIRVO 2 device is feasible, 448 that rhinothermy is well tolerated, and that the estimated change denoting substantial clinical 449 benefit for the modified Jackson score is a five unit change. Co.....
    Document: Our study has also been informative in terms of the likely number of participants required in a 430 RCT. We have estimated the change in modified Jackson score which denotes substantial 431 This study shows that an RCT of rhinothermy with the modified myAIRVO 2 device is feasible, 448 that rhinothermy is well tolerated, and that the estimated change denoting substantial clinical 449 benefit for the modified Jackson score is a five unit change. Compared with a low dose of vitamin 450 C in established common colds, rhinothermy improves symptoms by at least the substantial 451 clinical benefit threshold between days 3 and 5. These efficacy findings now require replication in 452 a larger study of common colds. Investigation of the efficacy of rhinothermy in the treatment of 453 influenza is also a priority, in view of the temperature-sensitivity of influenza viruses, [ 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 Results: In all 30/79 (38%, 95% CI 27 to 50) of potential participants screened for eligibility 50 were randomised. Rhinothermy was well tolerated and all randomised participants completed 51 the study (100%, 95% CI 88 to 100%). The reduction from baseline in the modified Jackson 52 score was greater with rhinothermy compared with control at days 2, 3, 4, 5, and 6, with the 53 maximum difference at day 4 (-6.4, 95%CI -9.4 to -3.3). The substantial clinical benefit threshold 54 for modified Jackson score was a 5 unit change. 55 • This open-label randomised controlled feasibility study shows that an RCT of 63 rhinothermy compared with low-dose vitamin C in the treatment of the common cold is 64 feasible. 65

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