Phase I/IIa Study on Chitin Microparticles in Subjects Suffering From Allergic Rhinitis
Status:
Completed
Trial end date:
2007-03-01
Target enrollment:
Participant gender:
Summary
Chitin microparticles (CMP) has been demonstrated in animal studies that have modelled
allergic rhinitis to be effective against a wide range of common respiratory allergens. It is
an immuneenhancer.
The primary purpose of the study is to demonstrate safety in a first into man study on 24
human volunteers. The secondary objective is to demonstrate efficacy by chosing subjects that
demonstrate a response to a nasal allergen challenge using grass pollen.
The subjects are being given increasing doses of CMP, supplied as a nasal spray, for 7 days
followed by a nasal allergen challenge with Timothy Grass Pollen extract. Over this period
nasal symptom scores, eosinophil counts and cytokine measurements will be performed.