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

[28-30] The modified Jackson score is calculated from a symptom severity questionnaire 146 that consists of eight symptoms: sneezing, nasal discharge, nasal congestion, sore/scratchy 147 throat, cough, headache, malaise and fever/chills, which are scored on a scale from 0 to 3 (0 = 148 absent, 1 = mild, 2 = moderate, 3 = severe). The total score can range from 0 to 24. 149 150 Participants were not recruited if they had: 1) An immunosuppressive medical condition and/or 151 were prescribed immunosuppressive medications; 2) A diagnosis of asthma, COPD or other 152 significant respiratory conditions; 3) Nasal conditions such as a deviated septum or chronic 153 rhinitis, which could impair nasal breathing; 4) Use of cold remedies e.g. decongestants/cough, 154 linctus/throat lozenges, within 6 hours of randomisation; 5) Currently using antibiotics or 155 inhalation medication; 6) Known allergy to ascorbic acid (Vitamin C); 7) The investigator 156 believed the participant or their care giver would be unable to safely use the myAIRVO 2 device 157 without medical supervision; 8) Had any other condition which, at the investigator's discretion, 158 was believed may present a safety risk or impact the feasibility of the study or the study results. 159 Paykel Healthcare New Zealand, the manufacturer of the myAIRVO 2 device. Written informed 163 consent was obtained before starting any study specific procedures. During the study 164 participants were able to stop the intervention at any time, without being withdrawn from the 165 study. Participants were also able to withdraw from the study at any time without giving a 166 reason. 167 168