Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000183684
Ethics application status
Approved
Date submitted
11/02/2014
Date registered
18/02/2014
Date last updated
28/07/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Tolerability study of nasal delivery of humidified & warmed air
Scientific title
Healthy subjects using nasal high flow delivery of humdified and warmed air at different temperatures to assess tolerability.
Secondary ID [1] 284061 0
nil
Universal Trial Number (UTN)
U1111-1147-1523
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tolerability in health, for further use on patients with the common cold. 291117 0
Condition category
Condition code
Respiratory 291459 291459 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 Participants are able to stop the intervention at any time, without being withdrawn from subsequent portions of the study.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)
Intervention code [1] 288753 0
Treatment: Devices
Comparator / control treatment
Use of nasal high flow air that has been humidified and warmed to 37 degrees C
Control group
Active

Outcomes
Primary outcome [1] 291440 0
Intervention Tolerability Questionnaire results
Timepoint [1] 291440 0
Following intervention A and B at the end of visit 1 and visit 3, ie approximately 7 hours after time 0 at each visit.
Secondary outcome [1] 306775 0
Number of participants who did not tolerate the intervention for 60 minutes, and length of time it was tolerated for
Timepoint [1] 306775 0
Following intervention A and B at the end of visit 1 and visit 3, ie approximately 7 hours after time 0 at each visit.
Secondary outcome [2] 306776 0
Effect on nasal mucociliary function - change in saccharin test times from baseline
Timepoint [2] 306776 0
Ten minutes after intervention A and B (approximately 7 hours and ten minutes after time 0) in visit 1 and 3, and 22-26 hours following Time 0 in visit 2 and 4.

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potentially eligible participants will be sought through word of mouth and advertising. A Participant Information Sheet (PIS) will be sent in reply to interest. Answers to questions, information about the study and booking of visits will take place over email and/or phone by a blinded investigator. An unblinded investigator will then be responsible for the order in which subject receives the intervention, which will be generated by random numbers and placed in sealed opaque envelopes arranged by study statistician (also unblinded).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computerised randomisation sequence will be generated by the study statistician and given to one unblinded investigator who will be responsible for allocation of interventions A and B.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Bio-equivalence
Statistical methods / analysis
mixed linear model (with baseline measure as co-variate) where applicable

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/02/2014
Actual
18/03/2014
Date of last participant enrolment
Anticipated
28/04/2014
Actual
13/05/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 5815 0
New Zealand
State/province [1] 5815 0

Funding & Sponsors
Funding source category [1] 288687 0
Commercial sector/Industry
Name [1] 288687 0
Fisher and Paykel
Country [1] 288687 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel
Address
15 Maurice Paykel Place, East Tamaki, Auckland 2013, NZ
Country
New Zealand
Secondary sponsor category [1] 287395 0
None
Name [1] 287395 0
Address [1] 287395 0
Country [1] 287395 0
Other collaborator category [1] 277812 0
Other Collaborative groups
Name [1] 277812 0
Medical Research Institute of NZ
Address [1] 277812 0
Level 7, CSB building, Wellington Hospital, Riddiford St, Newtown, Wellington 6021, NZ
Country [1] 277812 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290533 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 290533 0
c/o MEDSAFE
Level 6
Deloitte House
10 Brandon St
PO Box 5013
Wellington 6011
Ethics committee country [1] 290533 0
New Zealand
Date submitted for ethics approval [1] 290533 0
02/09/2013
Approval date [1] 290533 0
14/10/2013
Ethics approval number [1] 290533 0
13/NTA/150

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46130 0
Prof Richard Beasley
Address 46130 0
MRINZ
Level 7, CSB building
Wellington Hospital
Riddiford St
Newtown
Wellington 6021
Country 46130 0
New Zealand
Phone 46130 0
+6448050147
Fax 46130 0
Email 46130 0
richard.beasley@mrinz.ac.nz
Contact person for public queries
Name 46131 0
Dr Janine Pilcher
Address 46131 0
MRINZ
Level 7, CSB building
Wellington Hospital
Riddiford St
Newtown
Wellington 6021
Country 46131 0
New Zealand
Phone 46131 0
+6448050241
Fax 46131 0
Email 46131 0
janine.pilcher@mrinz.ac.nz
Contact person for scientific queries
Name 46132 0
Dr Janine Pilcher
Address 46132 0
MRINZ
Level 7, CSB building
Wellington Hospital
Riddiford St
Newtown
Wellington 6021
Country 46132 0
New Zealand
Phone 46132 0
+6448050241
Fax 46132 0
Email 46132 0
janine.pilcher@mrinz.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTolerability of Nasal Delivery of Humidified and Warmed Air at Different Temperatures: A Randomised Double-Blind Pilot Study.2016https://dx.doi.org/10.1155/2016/7951272
N.B. These documents automatically identified may not have been verified by the study sponsor.