Bio-availability of nasal capsaicin.
- Conditions
- This product would be used in patients with non-allergic rhinitis. In the study, healthy adult volunteers were recruitedInflammatory and Immune System - Allergies
- Registration Number
- ACTRN12623000410651
- Lead Sponsor
- Professor Peter Smith
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 26
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.
- 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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.[5 min, 10 min, 1h, 3h, 6h post administration.]
- Secondary Outcome Measures
Name Time Method o Secondary outcome measured.[N/A]