None listed
Conditions
Brief summary
The primary aim of this study is to investigate whether participants with the common cold will have improved outcomes (including symptom burden) using Rhinothermy via Nasal High Flow (rNHF) therapy compared to a ‘control’ treatment. The Rhinothermy Nasal High Flow (rNHF) device delivers warmed, humidified air at high flow to airways via a nasal cannula. This is a randomised, open-label, parallel group trial of 5 days of either nasal high flow rhinothermy (rNHF) therapy (100% humidified air at 35L/min and 41°C for 2 hours daily) or ‘sham’ rhinothermy therapy (100% humidified air at 10L/min and 31°C for 10 minutes daily) in the treatment of the common cold. 170 participants will be recruited within 48 hours of the onset of specific symptoms of the common cold. They will be randomised into 1 of 2 arms and receive the intervention for 5 days. There will be 2 visits to the MRINZ clinic. Questionnaire data will be collected both in person and remotely via smartphone or paper questionnaires.
Interventions
There are two possible interventions:
1. Standard repeat dose rhinothermy (rNHF): 100% humidified air delivered via the rNHF device, via nasal cannulae, at 35L/min and 41°C for 2 hours daily for 5 days. On Day 1 this will be administered under the supervision of investigators at the clinic and then participants will go on to self-administer the treatment at home for a further 4 days. The participant will be encouraged to self-administer their rhinothermy in a single 2 hour session on each day of
There are two possible interventions: 1. Standard repeat dose rhinothermy (rNHF): 100% humidified air delivered via the rNHF device, via nasal cannulae, at 35L/min and 41°C for 2 hours daily for 5 days. On Day 1 this will be administered under the supervision of investigators at the clinic and then participants will go on to self-administer the treatment at home for a further 4 days. The participant will be encouraged to self-administer their rhinothermy in a single 2 hour session on each day of treatment. However, if the participant is unable to do so, then the daily rhinothermy treatment can be split into 2 sessions aiming for the participant to complete a total of 2 hours of rhinothermy each day. Participants may also reduce the flow to a minimum of 30L/min at home according to comfort. 2. ‘Sham’ rhinothermy: 100% humidified air delivered via the myAIRVO 2 device at 10L/min and 31°C for 10 minutes daily for 5 days. On Day 1 this will be administered under the supervision of investigators at the clinic and then participants will go on to self-administer the treatment at home for a further 4 days. The participant will be encouraged to self-administer the ‘sham’ rhinothermy in a single 10 minute session on each day of treatment. Adherence to the standard repeat dose rhinothermy (rNHF) and ‘sham’ rhinothermy device treatments will be assessed by investigator review of the device data. Adherence to rNHF will be defined as a minimum of 90 minutes use per day, delivered in no more than 2 sessions per day. Adherence to ’sham’ rhinothermy will be defined as a minimum of 6 minutes use per day, delivered in no more than a single session.
Sponsors
Fisher & Paykel Healthcare Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
• Aged 18 to 75 years. • In the Investigator’s opinion, is able and willing to comply with all trial requirements. • Onset of symptoms within the last 48 hours at time of consent. • A NEGATIVE test for Influenza A and B viruses using the GeneXpert® Xpress Flu/RSV point-of-care test (Cepheid, Ca, USA)
Exclusion criteria
• Immunocompromised condition: o Conditions causing immunosuppression e.g. HIV/AIDS, active cancer o Currently prescribed systemic steroids or other immunosuppressant medication • Nasal conditions such as deviated septum, chronic rhinitis, which the investigator considers could impair nasal breathing. • Current use of or requirement for oral antibiotics for respiratory tract infection, pneumonia or infective exacerbation of underlying respiratory condition. • Current use of or requirement for parenteral antibiotics. • Daily intra-nasal or inhaled steroids will be allowed if part of the participant’s regular therapy. If not taken prior to enrolment, they should be withheld for the duration of this study. • The investigator believes the participant or their care giver will be unable to safely use rNHF without medical supervision. • Have 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. • Have an implantable medical device. • Have a notifiable disease • Have existing travel plans that require them to leave the greater Wellington region during the first 5 days of the study (the period during which the participant will be using the rhinothermy device. • A current diagnosis of asthma, COPD or other significant respiratory conditions. (Participants who have not had asthma symptoms nor any requirement for asthma medication within the last 12 months, will be eligible for inclusion in the study.) • A positive influenza point of care screening test.
Outcome results
None listed