None listed
Conditions
Brief summary
The aim of this feasibility study is to provide data for a future randomized controlled trial examining the impact of rhinothermy, delivered by the myAIRVO 2 at the set temperature of 41 degrees Celsius, on common cold symptoms. The common cold is the most frequent population-wide acute illness; on average, adults suffer from 2-4 colds per year. A Cochrane review of the use of steam in the common cold advises a large, multicentre study using rhinothermy to treat the common cold. Entry criteria is based on reported symptoms in subjects with a common cold for less than 48 hours. Participants will undergo an informed consent process, gathering personal/medical information and a nasal swab for PCR analysis for the presence of respiratory viruses. They will then be randomised in a 2:1 fashion to receive either myAIRVO 2 or control group (Vitamin C tablets. They will be followed up for a total of 10 days from randomisation. They will be asked to complete the modified Jackson score questionnaire daily for 10 days, a tick box to say when they’re feeling “a lot better, and a myAIRVO 2 tolerability questionnaire after 10 days. The primary aim of the study is to identify the proportion of potential recruits screened to randomise 30 patients. Other outcomes include rates of withdrawal from the study, reduction in modified Jackson score from randomisation to 24 hours, 48 hours and 5 days, time until feeling “a lot better”, time until resolution of symptoms, proportion of organisms identified by PCR analysis, patterns of us of the myAIRVO2 device, patterns of use of the control group and how well participants tolerate the myAIRVO2 device.
Interventions
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 pa
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.
Sponsors
Fisher & Paykel Healthcare
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to 75 Years
Healthy volunteers
No
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
Exclusion criteria
1. Age <16 years or >75 years 2. Immunocompromised condition: - Conditions causing immunosuppression e.g. HIV/AIDS, active cancer - Currently prescribed steroids or other immunosuppressant medication 3. A diagnosis of asthma, COPD or other significant respiratory conditions 4. Nasal conditions such as deviated septum, chronic rhinitis, which, in the evaluation by the investigator, could impair nasal breathing. 5. Use of cold remedies e.g. decongestants/cough linctus/sore throat lozenges within 6 hours of randomisation. 6. Current use of antibiotics, steroids or inhaled medications. 7. The investigator believes the participant or their care giver will be unable to safely use the myAIRVO 2 device following discharge 8. Any other condition which, at the investigator’s discretion, is believed may present a safety risk or impact the feasibility of the study or the study results.
Outcome results
None listed