Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000410651
Ethics application status
Approved
Date submitted
20/01/2023
Date registered
26/04/2023
Date last updated
26/04/2023
Date data sharing statement initially provided
26/04/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Bio-availability of nasal capsaicin.
Scientific title
Assessment of systemic pharmacokinetics of capsaicin following intranasal administration of a recognised therapeutic dose in healthy adults
Secondary ID [1] 308786 0
Nil Known
Universal Trial Number (UTN)
No UTN
Trial acronym
No Acronym
Linked study record
No linked study record

Health condition
Health condition(s) or problem(s) studied:
This product would be used in patients with non-allergic rhinitis. In the study, healthy adult volunteers were recruited 328737 0
Condition category
Condition code
Inflammatory and Immune System 325742 325742 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After consent, patients will be medically examined to ensure that they are healthy and meet recruitment criteria. A phlebotomist will insert a cannula or butterfly for repeated blood draws and sample a time zero sample. 2 sprays of capsaicin will be administered intranasally with instruction not to sniff it back. Water will be available. Blood will be collected at the time points 5 min, 10min, 1hr, 3 hr, 6 hr after the nasal application of the 0.01mM and 0.1mM nasal sprays. A nurse and physician will be present for the 6 hours post dosing. Most symptoms from dosing are settled by 5 minutes. Samples will be spun down and stored at minus 20 degrees for subsequent analysis. The dose will be 2 x sprays of 0.1 mL each, in immediate succession and in each nostril. This is non randomised. The first challenge will be 0.01mM. A fortnight later the 0.1mM spray will be given. This will allow adequate washout time.
Intervention code [1] 325296 0
Treatment: Other
Comparator / control treatment
The systemic availability and kinetics of a time degradation curve of Capsaicin at 2 different strengths - namely 0.01mM/L and 0.1mMol/L will be compared.
Control group
Active

Outcomes
Primary outcome [1] 333593 0
To determine the mean concentration of capsaicin in the blood at 5 times points: 5 min, 10 min, 1h, 3h, 6h after nasal application of the 0.01 mM and 0.1 mM. A baseline recording of time Zero will be recorded as well.
Timepoint [1] 333593 0
5 min, 10 min, 1h, 3h, 6h post administration.
Secondary outcome [1] 417657 0
No Secondary outcome measured.
Timepoint [1] 417657 0
N/A

Eligibility
Key inclusion criteria
- Aged 18-55 years;
= Healthy volunteers as defined by no acute or chronic airway illness or a smoker
- Complete informed consent to nasal capsaicin at 2 time points (at least 2 weeks apart)
- Agree to the measurement of blood samples at 5 time points.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Asthma, Allergic or Non-Allergic Rhinitis, Intercurrent illness, Chronic rhinosinusitis or have a history of psychiatric disorders or is unreliable in the opinion of the investigator Have a known sensitivity to capsaicin or any ingredients in the formulation
- Are a smoker
- Have any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial
- Are a female participant who is currently pregnant or breast-feeding.
- Have participated in an interventional Trial with an investigational medicinal product (IMP) or device 30 days before signing informed consent.
- Have used any nasal medication that may have an influence on the nasal homeostasis or nasal physiology within 1 week before the capsaicin application

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No concealment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The trial is open and sequential The first dose will be given and 2 weeks the 10x greater dose will be given and measurements of blood taken over 6 hours.
Phase
Not Applicable
Type of endpoint/s
Bio-availability
Statistical methods / analysis
Mean and SD of timepoints for the 2 described concentrations of capsaicin
The participants will have 2 longitudinal measurements of a 10 fold increase in capsaicin over 6 hours, separated by 14 days .

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/01/2023
Date of last participant enrolment
Anticipated
Actual
4/02/2023
Date of last data collection
Anticipated
Actual
22/02/2023
Sample size
Target
26
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 313002 0
Self funded/Unfunded
Name [1] 313002 0
Queensland Allergy Services
Country [1] 313002 0
Australia
Primary sponsor type
Individual
Name
Professor Peter Smith
Address
Queensland Allergy Services, 17/123 Nerang ST Southport QLD 4215
Country
Australia
Secondary sponsor category [1] 314688 0
None
Name [1] 314688 0
Address [1] 314688 0
Country [1] 314688 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312267 0
National Institute of Integrative Medicine
Ethics committee address [1] 312267 0
Ethics committee country [1] 312267 0
Australia
Date submitted for ethics approval [1] 312267 0
14/11/2022
Approval date [1] 312267 0
20/12/2022
Ethics approval number [1] 312267 0
0118E_2022

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

Contacts
Principal investigator
Name 124042 0
Prof Peter Smith
Address 124042 0
Queensland Allergy Services, 17/123 Nerang ST Qld Southport 4215
Country 124042 0
Australia
Phone 124042 0
+61 0439895599
Fax 124042 0
Email 124042 0
pksm@mac.com
Contact person for public queries
Name 124043 0
Peter Smith
Address 124043 0
Queensland Allergy Services, 17/123 Nerang ST Qld Southport 4215
Country 124043 0
Australia
Phone 124043 0
+61 0439895599
Fax 124043 0
Email 124043 0
pksm@mac.com
Contact person for scientific queries
Name 124044 0
Peter Smith
Address 124044 0
Queensland Allergy Services, 17/123 Nerang ST Qld Southport 4215
Country 124044 0
Australia
Phone 124044 0
+61 0439895599
Fax 124044 0
Email 124044 0
pksm@mac.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Age
Gender
When will data be available (start and end dates)?
ASAP and completion by March 31 2023
Available to whom?
To sponsor and research colleagues
Available for what types of analyses?
To see if there is any variation in bioavailability with age and gender
How or where can data be obtained?
Contact Sponsor pksm@mac.com


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18069Study protocol    385246-(Uploaded-26-01-2023-20-08-17)-Study-related document.docx
18086Ethical approval    385246-(Uploaded-20-01-2023-12-40-17)-Study-related document.pdf
18087Informed consent form    385246-(Uploaded-20-01-2023-12-48-24)-Study-related document.doc



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.