Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001908
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
T Cell Cytokine Changes During IL-4 Receptor Treatment for Asthma
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
T Cell Cytokine Changes During IL-4 Receptor Treatment for Asthma
Status:
COMPLETED
Status Verified Date:
2001-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Asthma is a chronic inflammatory disorder of the airways characterized by reversible airflow obstruction Fourteen million people 64 in the United States report having asthma and from 1980 to 1994 the prevalence of self-reported asthma in the United States increased 75 Interleukin-4 IL-4 plays a key role in this response by promoting IgE production upregulating IgE receptors upregulating adhesion receptors such as VCAM-1 promoting Th2 cell development and promoting mucus secretion A soluble form of the receptor for IL-4 IL-4R that has antagonist activity has been developed for clinical use Soluble IL-4R acts by competing with endogenous cell bound IL-4R for free IL-4 thus inhibiting IL-4 function IL-4 is required for the development of allergen specific Th2 memory cells Less well understood are the factors required for maintenance of Th2 responses The maintenance of polarized Th2 responses to allergens have been postulated to require IL-4 itself by acting as an anti-apoptoticsurvival factor or by differentiating naive allergen specific T cells to the Th2 phenotype Subjects on sIL-4 therapy represent a unique patient group that possess allergen specific Th2 cells but in which the capacity for IL-4 to promote further Th2 cell survival or differentiation has been blocked This is a single site adjunct study proposed to study subjects ages 14 years and older who are enrolled at the NIH Clinical Center on a multicenter trial of IL-4R in moderate to severe asthma Phase II Efficacy Study of Aerosolized Recombinant Human IL-4 Receptor in Asthma A maximum of 40 subjects will be enrolled We hypothesize that effective blocking of such Th2 priming would result in a decreased frequency of both allergen specific Th2 cells as well as mitogen activated Th2 cells Determination of the fate of Th2 cell responses during long term IL-4R therapy may have important implications both for future development of anti-cytokine therapies as well as for understanding the T cell biology of allergic diseases and asthma
Detailed Description:
Asthma is a chronic inflammatory disorder of the airways characterized by reversible airflow obstruction Fourteen million people 64 in the United States report having asthma and from 1980 to 1994 the prevalence of self-reported asthma in the United States increased 75 Interleukin-4 IL-4 plays a key role in this response by promoting IgE production upregulating IgE receptors upregulating adhesion receptors such as VCAM-1 promoting Th2 cell development and promoting mucus secretion A soluble form of the receptor for IL-4 IL-4R that has antagonist activity has been developed for clinical use Soluble IL-4R acts by competing with endogenous cell bound IL-4R for free IL-4 thus inhibiting IL-4 function IL-4 is required for the development of allergen specific Th2 memory cells Less well understood are the factors required for maintenance of Th2 responses The maintenance of polarized Th2 responses to allergens have been postulated to require IL-4 itself by acting as an anti-apoptoticsurvival factor or by differentiating naive allergen specific T cells to the Th2 phenotype Subjects on sIL-4 therapy represent a unique patient group that possess allergen specific Th2 cells but in which the capacity for IL-4 to promote further Th2 cell survival or differentiation has been blocked This is a single site adjunct study proposed to study subjects ages 14 years and older who are enrolled at the NIH Clinical Center on a multicenter trial of IL-4R in moderate to severe asthma Phase II Efficacy Study of Aerosolized Recombinant Human IL-4 Receptor in Asthma A maximum of 40 subjects will be enrolled We hypothesize that effective blocking of such Th2 priming would result in a decreased frequency of both allergen specific Th2 cells as well as mitogen activated Th2 cells Determination of the fate of Th2 cell responses during long term IL-4R therapy may have important implications both for future development of anti-cytokine therapies as well as for understanding the T cell biology of allergic diseases and asthma
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-I-0114 | None | None | None |