None listed
Conditions
Brief summary
This study is intended to assess a device which could help treatment of the common cold in people both with and without chronic respiratory disease such as asthma and COPD. Cold viruses are sensitive to heat, and warmed humidified air may improve nasal drainage. The Airvo device can deliver nasal high flow humidified air at 37 degrees (as commonly used in hospitals) or can be modified to deliver air at 41 degrees, which (based on in vitro work) should destroy the cold virus and reduce transmission more effectively. However, clinical risk and tolerability of air at this temperature as compared to standard settings must be assessed before further research is undertaken. We hypothesise that the setting at 41 degrees will be as well tolerated as 37 degrees, for use in three periods of 60 minutes, with no decrease in nasal mucociliary clearance.
Interventions
Four visits per subject will take place. The study will be undertaken at the Medical Research Institute of New Zealand at Wellington Regional Hospital. Participants are able to stop the intervention at any time, without being withdrawn from subsequent portions of the study. Subjects will be randomised to the order they receive:
- Intervention A: humidified air at a flow of 35 Litres at 37 degrees Celsius from the Fisher & Paykel Healthcare Airvo device for 60 minutes
- Intervention B: humidifie
Four visits per subject will take place. The study will be undertaken at the Medical Research Institute of New Zealand at Wellington Regional Hospital. Participants are able to stop the intervention at any time, without being withdrawn from subsequent portions of the study. Subjects will be randomised to the order they receive: - Intervention A: humidified air at a flow of 35 Litres at 37 degrees Celsius from the Fisher & Paykel Healthcare Airvo device for 60 minutes - Intervention B: humidified air at a flow of 35 Litres at 41 degrees Celsius from the Fisher & Paykel Healthcare Airvo device for 60 minutes Visit 1 1. Written informed consent, inclusion/exclusion criteria check, collection of demographic data (including, age, gender, ethnicity). 2. Baseline Saccharin test 3. Delivery of intervention (A or B) (Time 0) 4. Delivery of same intervention 3 hours after Time 0 5. Delivery of same intervention 6 hours after Time 0 6. Administration of the Intervention Tolerability Questionnaire 7. Saccharin test 10 minutes after completion of step 5 . Visit 2 (to start 24 hours after Visit 1) 1. Saccharin test (performed 22-26 hours following Time 0 in visit 1) Visit 3 (to start at least 14 days following Visit 1): 1. Inclusion/exclusion criteria check 2. Baseline Saccharin test 3. Delivery of intervention (A or B) (Time 0) 4. Delivery of same intervention 3 hours after Time 0 5. Delivery of same intervention 6 hours after Time 0 6. Administration of the Intervention Tolerability Questionnaire 7. Saccharin test 10 minutes after completion of step 5. Visit 4 (to start 24 hours after Visit 3) 1. Saccharin test (performed 22-26 hours following Time 0 in visit 3)
Sponsors
Fisher and Paykel
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
10 healthy subjects without recent upper respiratory tract infection (defined as sore throat, cough, runny nose and/or raised temperature (subjective or objectively measured) within the last 7 days)
Exclusion criteria
1. Age under 18 years 2. Asthma or Chronic Obstructive Pulmonary Disease (COPD) requiring medication use in the past 6 months 3. Sinusitis and/or use of nasal sprays in the last 7 days 4. Current smoker, defined as cigarette use in the last month 5. 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