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

The screening process involves a number of steps; 1. We make sure you are the right age for the studies, and that you don't have any medical conditions or take any medications that might make you ineligible for either study We make sure we are comfortable that you are able to complete all the tasks in either study 3. We make sure that you are happy for your usual doctor to be advised that you are enrolled in the cold or flu study if you DO end up in one of them. 4. We ask you to fill in two questionnaires a. One about flu symptoms b. One about common cold symptoms 5. Depending on the answers to the two symptom questionnaires, you may be asked to provide us with a sample from the back of your nose, which we will take with a swab through one nostril. This sample will be tested for the presence or absence of the flu virus. 6. If you have a negative test for the flu from your nose swab, and your cold symptom score meets the entry criteria, you will be advised that you are eligible for the cold study. a. You will receive a separate informed consent form for the cold study that will outline the process specifically for that study 7. If you have a positive test for the flu from your nose swab, and your flu symptom questionnaire meets the entry criteria, you will be advised that you are eligible for the flu study. a. Please note, female participants who reach this point will be asked to undertake a urinary pregnancy test, as pregnant females will be excluded from the flu study. b. All eligible participants will receive a separate informed consent form for the flu study that will outline the process specifically for that study. 8. There may be some people who have the wrong combination of cold or flu symptoms and flu test results, and will not be suitable for either study. If you are not suitable, you will be reimbursed for your time and travel. 9. If you are enrolled in either study, we will ask that for the first five days of the study, while you are taking one of the randomised treatments, you refrain from leaving the greater Wellington region (not beyond Upper Hut or Paraparaumu). If you have existing travel plans that require you to leave the greater Wellington region, you will be advised that you are not eligible for the study.