Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000470493
Ethics application status
Approved
Date submitted
1/04/2016
Date registered
11/04/2016
Date last updated
17/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Inhalation of heated, humidified air (rhinothermy) in the common cold: a feasibility study
Scientific title
A randomised controlled trial investigating Inhalation of heated, humidified air against placebo in people with the common cold: a feasibility study
Secondary ID [1] 288907 0
Nil known
Universal Trial Number (UTN)
U1111-1180-2786
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Common cold 298243 0
Condition category
Condition code
Infection 298447 298447 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 294371 0
Treatment: Devices
Comparator / control treatment
Participants in this group will receive Vitamin C 250mg tablets that they will take orally once daily for 5 days. They will be asked to return the bottle they received them in and remaining pills will be counted to check compliance.
Control group
Active

Outcomes
Primary outcome [1] 297856 0
Proportion of potential recruits screened to randomise 30 participants.
Timepoint [1] 297856 0
Once 30 participants have been randomised
Secondary outcome [1] 322457 0
A log will be maintained for participant withdrawal and reasons if they volunteer this information.
Timepoint [1] 322457 0
At completion of study
Secondary outcome [2] 322458 0
Mean and SD of percentage reduction in modified Jackson score* from randomisation to 5 days 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.
Timepoint [2] 322458 0
5 days after randomization
Secondary outcome [3] 322459 0
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.
Timepoint [3] 322459 0
24 and 48 hours after randomisation
Secondary outcome [4] 322460 0
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.
Timepoint [4] 322460 0
Up to 10 days after randomisation or not recorded at all.
Secondary outcome [5] 322461 0
Time until resolution of symptoms or symptom score at 10 days post randomisation, as measured by the modified Jackson score questionnaire.
Timepoint [5] 322461 0
10 days after randomisation.
Secondary outcome [6] 322462 0
Proportion of organisms identified by PCR analysis of nasal swabs taken at baseline .
Timepoint [6] 322462 0
Baseline
Secondary outcome [7] 322463 0
The patterns of use of the myAIRVO 2 device, as determined by electronic monitoring capabilities of the myAIRVO 2.
Timepoint [7] 322463 0
5 days after randomisation.
Secondary outcome [8] 322464 0
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.
Timepoint [8] 322464 0
5 days after randomisation.
Secondary outcome [9] 322465 0
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.
Timepoint [9] 322465 0
10 days after randomization.

Eligibility
Key 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
Minimum age
16 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

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)
Participants will be considered enrolled and part of the study population at the time the inclusion and exclusion criteria have been met and the consent form has been filled in by both the participant and Study Investigator. The investigator will open an opaque envelope containing the randomised treatment and administer the randomised treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation code will be pre-generated by the study statistician by computer and stored in a sealed opaque envelope which will be opened by the Investigator at randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants will be randomised in a 2:1 fashion (for AIRVO, n=20; for placebo, n=10)
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/04/2016
Actual
12/05/2016
Date of last participant enrolment
Anticipated
31/10/2016
Actual
13/07/2016
Date of last data collection
Anticipated
Actual
22/07/2016
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 7763 0
New Zealand
State/province [1] 7763 0
Wellington

Funding & Sponsors
Funding source category [1] 293257 0
Commercial sector/Industry
Name [1] 293257 0
Fisher & Paykel Healthcare
Country [1] 293257 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher & Paykel Healthcare
Address
15 Maurice Paykel
East Tamaki
Auckland 2013
Country
New Zealand
Secondary sponsor category [1] 292061 0
None
Name [1] 292061 0
Address [1] 292061 0
Country [1] 292061 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294737 0
Health and Disability Ethics Committee New Zealand
Ethics committee address [1] 294737 0
Ministry of Health
Ethics Department
Reception - Ground Floor
20 Aitken Street
Thorndon
WELLINGTON 6011
Ethics committee country [1] 294737 0
New Zealand
Date submitted for ethics approval [1] 294737 0
11/03/2016
Approval date [1] 294737 0
21/03/2016
Ethics approval number [1] 294737 0
16/NTB/47

Summary
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.
Trial website
Trial related presentations / publications
https://www.ncbi.nlm.nih.gov/pubmed/29593018
Public notes

Contacts
Principal investigator
Name 64878 0
Dr James Fingleton
Address 64878 0
Medical Research Institute of New Zealand, Level 7, Clinical Services Building, Wellington
Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country 64878 0
New Zealand
Phone 64878 0
+64 4 8050147
Fax 64878 0
Email 64878 0
[email protected]
Contact person for public queries
Name 64879 0
Dr Steven McKinstry
Address 64879 0
Medical Research Institute of New Zealand, Level 7, Clinical Services Building, Wellington
Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country 64879 0
New Zealand
Phone 64879 0
+64 4 8050261
Fax 64879 0
Email 64879 0
[email protected]
Contact person for scientific queries
Name 64880 0
Dr Steven McKinstry
Address 64880 0
Medical Research Institute of New Zealand, Level 7, Clinical Services Building, Wellington
Regional Hospital, Riddiford Street, Newtown, Wellington 6021
Country 64880 0
New Zealand
Phone 64880 0
+64 4 8050261
Fax 64880 0
Email 64880 0
[email protected]

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
EmbaseRandomised controlled trial of rhinothermy for treatment of the common cold: A feasibility study.2018https://dx.doi.org/10.1136/bmjopen-2017-019350
N.B. These documents automatically identified may not have been verified by the study sponsor.