Inhalation of heated, humidified air (rhinothermy) in the common cold: a feasibility study

INTERVENTION: There will be a Nasal high flow (NHF) intervention using myAIRVO 2 which involves breathing heated and humidified room air through a nasal interface (nasal prongs which sit inside both nostrils). The air will be delivered by the myAIRVO 2 device at 35L/min at 41 degrees Celsius for two continuous hours on Day 1, administered under the supervision of investigators at the Clinical Trials Unit at Wellington Hospital, and then self‐use at home up to day 5, depending on resolution of symptoms. The participant will be encouraged to use the myAIRVO 2 device for 2 hours in total per day at home during this period, in either a single or repeated administration. Participants may change the flow between 30‐35L/min at home according to comfort, and down to a minimum of 25L/min if needed. Compliance will be assessed by the myAIRVO 2 electronic monitoring capability at the completion of the trial. The intervention will be administered by the study investigator (registered doctor) or sub‐investigators who have been appropriately trained eg clinical trials unit study nurses Intervention will be for a total of 5 days ie day 1 at clinical trials unit and 4 further days at home. CONDITION: Common cold PRIMARY OUTCOME: Proportion of potential recruits screened to randomise 30 participants. SECONDARY OUTCOME: A log will be maintained for participant withdrawal and reasons if they volunteer this information. Mean and SD of percentage reduction in modified Jackson score* from randomisation to 24 and 48 hours after initiation of the randomised regimen. ; *A modified Jackson score will be used. This is a 24 point scale rating 8 individual symptoms from 0 (not present) to 3 (severe). This questionnaire will be completed daily for 10 days following randomisation for all participants. On Day 1, participants will be asked to complete a score prior to their allocated intervention. Changes in symptoms score will be calculated as a percentage from baseline. ; Mean and SD of percentage reduction in modified Jackson score* from randomisation to 5 days after initiation of the randomised regimen. INCLUSION CRITERIA: 1. Jackson score greater than or equal to 5 2. Symptoms have been present for less than 48 hours at time of randomisation ; *A modified Jackson score will be used. This is a 24 point scale rating 8 individual symptoms from 0 (not present) to 3 (severe). This questionnaire will be completed daily for 10 days following randomisation for all participants. On Day 1, participants will be asked to complete a score prior to their allocated intervention. Changes in symptoms score will be calculated as a percentage from baseline. Proportion of organisms identified by PCR analysis of nasal swabs taken at baseline . The patterns of use of control group. Participants return the bottle they receive the Vitamin C tablets in after 10 days. By counting how many tablets are left we can assess the patterns of use. The patterns of use of the myAIRVO 2 device, as determined by electronic monitoring capabilities of the myAIRVO 2. Time until feeling “a lot better” compared to study entry. This will be reviewed daily by particpants and indicated by a ticking a tick‐box. Time until resolution of symptoms or symptom score at 10 days post randomisation, as measured by the modified Jackson score questionnaire. TOLERABILITY OF myAIRVO 2 IN PARTICIPANTS WITH THE COMMON COLD questionnaire. This questionnaire is specific to this study but we have used similar continuous scale questionnaires in previous NHF trials.