Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-24 @ 1:33 PM
NCT ID:
NCT00443495
Brief 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.
Detailed Description:
Chitin microparticles are a special preparation of chitin. This a long chain polysaccaride derived from shells of the North Atlantic shrimp. CMP acts a an immunenhancer which improve immune function by stimulating macrophages and other cells such as T-helper lymphocytes, (Th cells). In allergies there is an imbalance between Th1 and Th2 cells. Imuneenhancers shift the balance in favour of Th1 cells. The immunomodulatory properties of CMP have been demonstrated in animal models against a wide range of respiratory allergens. There have been no indications of toxic side effects in animal models.
Study:
NCT00443495
Study Brief:
Protocol Section:
NCT00443495