None listed
Conditions
Brief summary
Nasal capsaicin is the standard of care for the treatment of non-allergic rhinitis. The capsaicin receptor (TRPV1) is widely present through the human body (Nobel Prize in Medicine 2021) and is related to pain and noxious stimuli. Nothing is published on the systemic availability of capsaicin after nasal administration.
Interventions
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
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.
Sponsors
Professor Peter Smith
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
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
Outcome results
None listed