Immunological Effects From Intranasal Chitin Micro-Particles (INCA)
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|ClinicalTrials.gov Identifier: NCT01508039|
Recruitment Status : Completed
First Posted : January 11, 2012
Last Update Posted : January 26, 2012
The purpose of the study is:
- To investigate whether chitin can effect healthy adults, the nasal mucosa in a direction that will enhance the immune response to infection
- To investigate whether chitin influence of the nasal mucosa is well tolerated, and that there is no inflammation, as it seen with exposure to endotoxin.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Other: Chitin Micro Particle||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomised, Double-blind,Single-dose,Placebo and Single-blind Active Controlled Cross-over Study in Healthy Volunteers to Access in Effects of Intranasal Chitin Micro-particles on the Release of Cytokines From Nasal Mucosa|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||July 2011|
Experimental: Treatment with chitin micro-particles
The study will involve 14-healthy subjects confirming to the inclusion criteria randomised to the treatments.
Other: Chitin Micro Particle
The total spray volume for each application is 0.4 ml equivalent to a total single-dose for chitin of 2 mg (0.5 mg per 0.1 ml spray).
A total single-dose for LPS, of 2 mg of endotoxin from Enterobacter agglomerans (0.5 mg per 0.1 ml spray)
Other Name: Chitin micro-particle
- Changes in levels of cytokines in nasal lavage fluid compared with dosing with placebo. [ Time Frame: Period 1, day 0. Period 2, day 14 ]Change in levels of cytokines (TNF-alfa, IFN-gamma, IL-1b, IL-4 IL5, IL, 6, IL-8, IL-10 and IL-13) in nasal lavage fluid compared to dosing with placebo.
- Changes in levels of cytokines in nasal lavage fluid compared with dosing with active control. [ Time Frame: Day0, day 14,day 28. ]Changes in levels (maximum concentration) of TNF-alfa, IFN-gamma, IL-1b, IL-4, IL5, IL-6, IL-8, IL-10 and IL-13 in nasal lavage samples following intranasal dosing with cmp compared to lipopolysaccharide active control.
- Change from baseline. [ Time Frame: Day 0, day 14, day 28 ]
The total eosinophil counts and cysteinyl leukotriene concentration in nasal lavage fluid following intranasal dosing with cmp.
Total nasal symptom scores at 4 and 8-hours following intranasal dosing with cmp.
- Safety check. [ Time Frame: Day0, day14, day 28. ]Safety will be assessed using the adverse events, vital signs and nasal acoustic rhinometry following dosing with cmp versus placebo.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01508039
|Aarhus University, School of Public Health, Dept. of Environmental & Occupational Medicine|
|Aarhus C, Denmark, 8000|
|Principal Investigator:||Torben Sigsgaard, Professor||Aarhus University, School of Public Health, Dept of Environmental & Occupational Medicine|