Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001340325
Ethics application status
Approved
Date submitted
12/09/2017
Date registered
21/09/2017
Date last updated
22/12/2020
Date data sharing statement initially provided
10/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Rhinothermy in the Common Cold (RiCC)
Scientific title
A randomised, single blind, two arm, parallel group controlled trial of the efficacy of rhinothermy delivered by nasal high flow (rNHF) therapy in the treatment of the common cold
Secondary ID [1] 292863 0
Nil known
Universal Trial Number (UTN)
U1111-1194-4345
Trial acronym
RiCC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Common cold 304710 0
Infection 304711 0
Condition category
Condition code
Infection 304018 304018 0 0
Other infectious diseases
Respiratory 304019 304019 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 299108 0
Treatment: Devices
Comparator / control treatment
‘Sham’ rhinothermy: 100% humidified air delivered via the myAIRVO 2 device at 10L/min and 31°C for 10 minutes daily for 5 days, will be used as the control treatment.
Control group
Active

Outcomes
Primary outcome [1] 303353 0
Day 4 Modified Jackson Symptom Score, as captured by participant daily symptom diary, adjusted for baseline (Day 1) modified Jackson Symptom Score.

The modified Jackson Score has previously been validated (Jackson GG, Dowling HF, Spiesman IG, et al. Transmission of the common cold to volunteers under controlled conditions. I. The common cold as a clinical entity. AMA Arch Intern Med 1958;101:267–78.http://www.ncbi.nlm.nih.gov/pubmed/13497324)
Timepoint [1] 303353 0
Day 4
Secondary outcome [1] 338719 0
Daily modified Jackson Symptom Score for 14 days, adjusted for baseline (Day 1) modified Jackson Symptom Score.

The modified Jackson Score has previously been validated (Jackson GG, Dowling HF, Spiesman IG, et al. Transmission of the common cold to volunteers under controlled conditions. I. The common cold as a clinical entity. AMA Arch Intern Med 1958;101:267–78.http://www.ncbi.nlm.nih.gov/pubmed/13497324)
Timepoint [1] 338719 0
Daily from day 2 to day 14 inclusive
Secondary outcome [2] 338720 0
Time until resolution of symptoms (defined as the start of a 24 hour period in which the modified Jackson Symptom Score was equal to 1 and remained so for 24 hours) as captured in the participant daily symptom diary.
Timepoint [2] 338720 0
Daily from day 2 to day 14 inclusive.
Secondary outcome [3] 338721 0
Time until feeling “a little better”compared to study entry (day 1), as captured in the participant daily symptom diary
Timepoint [3] 338721 0
Day 14
Secondary outcome [4] 338722 0
Time until feeling “a lot better” compared to study entry (day 1), as captured in the participant daily symptom diary
Timepoint [4] 338722 0
Day 14
Secondary outcome [5] 338723 0
This is a composite outcome variable: Proportion of isolates from each genus identified by PCR analysis of nasopharyngeal swabs taken at baseline (e.g. rhinovirus, coronavirus, influenza A, influenza B, Respiratory Syncytial Virus, parainfluenza virus, echovirus, coxsackie-virus), as elicited by multiplex respiratory testing for the presence of 21 respiratory pathogens. .
Timepoint [5] 338723 0
Day 1
Secondary outcome [6] 338724 0
The patterns of use of the rNHF device: mean number of minutes used per day.
This will be determined by the device use data downloaded from the device on Day 5.
Timepoint [6] 338724 0
Day 1 to day 5 inclusive
Secondary outcome [7] 338725 0
Ease of use of rNHF therapy. This will be determined by the participants on the Tolerability Questionnaire (given to the participants on Day 5) which has been designed specifically for this study.
Timepoint [7] 338725 0
Day 5
Secondary outcome [8] 338828 0
The patterns of use of the rNHF device: mean number of sessions per day.
This will be determined by the device use data downloaded from the device on Day 5.
Timepoint [8] 338828 0
Day 1 to day 5 inclusive
Secondary outcome [9] 338829 0
The adherence to rNHF therapy (defined as a minimum of 90 minutes use per day, delivered in no more than 2 sessions per day). This will be determined by device use data downloaded from the device on Day 5.
Timepoint [9] 338829 0
Day 1 to day 5 inclusive
Secondary outcome [10] 342085 0
The patterns of use of the rNHF device: average set flow rate (L/min)
This will be determined by the device use data downloaded from the device on Day 5.
Timepoint [10] 342085 0
Day 1 to day 5 inclusive
Secondary outcome [11] 342086 0
How comfortable the participant found using the rNHF device. This will be determined by the participants on the Tolerability Questionnaire (given to the participants on Day 5) which has been designed specifically for this study.
Timepoint [11] 342086 0
Day 5
Secondary outcome [12] 342087 0
The likelihood of participants using rNHF in the future. This will be determined by the participants on the Tolerability Questionnaire (given to the participants on Day 5) which has been designed specifically for this study.
Timepoint [12] 342087 0
Day 5

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

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)
A computer-generated sequence will be supplied by the study statistician, independent of the investigators. The electronic case report form (eCRF) system will conceal the allocations and will release a participant’s randomisation outcome at the time of randomisation. The randomisation schedule will be accessed only by the study statistician and the eCRF provider; study staff will not have access to the randomisation schedule
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised 1:1 to receive one of two possible treatment arms using a permuted block randomisation method, stratified by duration of illness (lesser versus greater than or equal to one day).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will be by intention to treat. The primary comparison is between the standard repeat dose rNHF regimen and Vitamin C treatment. The primary outcome variable will be analysed by ANCOVA with the baseline score as the covariate. A subgroup analysis will be carried out in those participants who are specific respiratory virus PCR-positive.

Any deviation(s) from the original statistical plan will be described and justified in the protocol or final report, as appropriate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/02/2018
Actual
3/02/2018
Date of last participant enrolment
Anticipated
30/04/2019
Actual
25/05/2019
Date of last data collection
Anticipated
17/05/2019
Actual
18/07/2019
Sample size
Target
170
Accrual to date
Final
170
Recruitment outside Australia
Country [1] 9198 0
New Zealand
State/province [1] 9198 0
Wellington

Funding & Sponsors
Funding source category [1] 297493 0
Commercial sector/Industry
Name [1] 297493 0
Fisher & Paykel Healthcare Limited
Country [1] 297493 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher & Paykel Healthcare Limited
Address
15 Maurice Paykel Place,
East Tamaki,
Auckland 2013,
New Zealand.
Country
New Zealand
Secondary sponsor category [1] 296499 0
None
Name [1] 296499 0
Address [1] 296499 0
Country [1] 296499 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298593 0
Southern HDEC
Ethics committee address [1] 298593 0
Ethics committee country [1] 298593 0
New Zealand
Date submitted for ethics approval [1] 298593 0
05/09/2017
Approval date [1] 298593 0
22/09/2017
Ethics approval number [1] 298593 0
17/STH/174

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77594 0
Dr Irene Braithwaite
Address 77594 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 77594 0
New Zealand
Phone 77594 0
+64 4 8050245
Fax 77594 0
+64 4 3895707
Email 77594 0
[email protected]
Contact person for public queries
Name 77595 0
Irene Braithwaite
Address 77595 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 77595 0
New Zealand
Phone 77595 0
+64 4 8050245
Fax 77595 0
+64 4 3895707
Email 77595 0
[email protected]
Contact person for scientific queries
Name 77596 0
Irene Braithwaite
Address 77596 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 77596 0
New Zealand
Phone 77596 0
+64 4 8050245
Fax 77596 0
+64 4 3895707
Email 77596 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant data will be grouped and analysed.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6118Study protocolBird G, Braithwaite I, Harper J, et al. Protocol for a randomised, single-blind, two-arm, parallel-group con-trolled trial of the efficacy of rhinothermy delivered by nasal high flow therapy in the treatment of the common cold. BMJ Open 2019;9:e028098. doi:10.1136/bmjopen-2018-028098https://bmjopen.bmj.com/content/9/6/e028098.info 
6119Clinical study report  [email protected]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProtocol for a randomised, single-blind, two-arm, parallel-group controlled trial of the efficacy of rhinothermy delivered by nasal high flow therapy in the treatment of the common cold.2019https://dx.doi.org/10.1136/bmjopen-2018-028098
N.B. These documents automatically identified may not have been verified by the study sponsor.