Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001909
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Phase II Efficacy Study of Aerosolized Recombinant Human IL-4 Receptor in Asthma
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase II Efficacy Study of Aerosolized Recombinant Human IL-4 Receptor in Asthma
Status:
COMPLETED
Status Verified Date:
1999-05
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 persons 64 in the United States report having asthma and from 1980 to 1994 the prevalence of self-reported asthma in the United States increased by 75 A major factor in the pathogenesis of asthma is the development of an allergic inflammatory response to inhaled antigens 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 increasing mucus secretion Soluble recombinantly produced IL-4R sIL-4R has been shown to bind and inactivate IL-4 both in vitro and in animal models As part of a multicenter trial 20 subjects at the NIH site will receive 09 mg 18 mg sIL-4R or placebo once weekly for 12 weeks in a double blind placebo controlled study Study drug will be delivered via the AERx aerosol drug delivery device The primary objective of the study will be to evaluate efficacy as measured by FEV1 Secondary objectives will include changes in FVC FEF 27-75 peak flow bronchodilator usage asthma symptoms quality of life scores immunologic and inflammatory markers pharmacokinetics safety and immunogenicity The study population will consist of moderate to severe asthmatics on Beta-agonist monotherapy with an FEV1 of 50-80 of predicted After 12 weeks of study drug subjects will be followed for an additional 8 weeks
Detailed Description:
Asthma is a chronic inflammatory disorder of the airways characterized by reversible airflow obstruction Fourteen million persons 64 in the United States report having asthma and from 1980 to 1994 the prevalence of self-reported asthma in the United States increased by 75 A major factor in the pathogenesis of asthma is the development of an allergic inflammatory response to inhaled antigens 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 increasing mucus secretion Soluble recombinantly produced IL-4R sIL-4R has been shown to bind and inactivate IL-4 both in vitro and in animal models As part of a multicenter trial 20 subjects at the NIH site will receive 09 mg 18 mg sIL-4R or placebo once weekly for 12 weeks in a double blind placebo controlled study Study drug will be delivered via the AERx aerosol drug delivery device The primary objective of the study will be to evaluate efficacy as measured by FEV1 Secondary objectives will include changes in FVC FEF 27-75 peak flow bronchodilator usage asthma symptoms quality of life scores immunologic and inflammatory markers pharmacokinetics safety and immunogenicity The study population will consist of moderate to severe asthmatics on Beta-agonist monotherapy with an FEV1 of 50-80 of predicted After 12 weeks of study drug subjects will be followed for an additional 8 weeks
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-0115 | None | None | None |