Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017693
Status:
COMPLETED
Last Update Posted:
2016-03-07
First Post:
2001-06-07
Brief Title:
Recombinant Human IL-4 Receptor Used in Treatment of Asthma
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase II Efficacy Study of Aerosolized Recombinant Human IL-4 Receptor in Asthma
Status:
COMPLETED
Status Verified Date:
2016-03
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:
The purpose is to measure the effectiveness of recombinant human interleukin-4 receptor IL-4R in treating asthma
Asthma can be caused by the allergic response from breathing in certain irritants Interleukin 4 IL-4 which is naturally produced by the body plays a major role in this allergic response Doctors feel that IL-4 activity may be stopped by giving IL-4R a product that binds to IL-4 and thereby decrease the problems of asthma
Asthma can be caused by the allergic response from breathing in certain irritants Interleukin 4 IL-4 which is naturally produced by the body plays a major role in this allergic response Doctors feel that IL-4 activity may be stopped by giving IL-4R a product that binds to IL-4 and thereby decrease the problems of asthma
Detailed Description:
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 Binding and inactivating the IL-4 molecule with IL-4R may diminish the allergic asthmatic response by inhibiting activities of IL-4
Patients are randomized to 1 of 3 treatment groups and within each group are stratified by baseline FEV1 cohort Patients receive either dose level 1 of IL-4R dose level 2 of IL-4R or placebo by aerosol drug delivery device once a week for 12 weeks There are frequent clinic visits and several follow-up visits Physical exams and spirometry are done regularly immunizations are administered on Day 28 and a skin tests panel is given on Day 84 Blood samples are collected at study visits during treatment and follow-up to test for immunologyserology parameters chemistry profiles and asthma-related DNA polymorphisms Patients are provided with peak flow meters and must demonstrate their proper use so that a peak expiratory flow PEF diary and a symptoms diary can be maintained Selected sites measure exhaled nitric oxide and collect induced sputum samples Assessments for adverse events are conducted at 16 and 40 weeks following the first study drug treatment
Patients are randomized to 1 of 3 treatment groups and within each group are stratified by baseline FEV1 cohort Patients receive either dose level 1 of IL-4R dose level 2 of IL-4R or placebo by aerosol drug delivery device once a week for 12 weeks There are frequent clinic visits and several follow-up visits Physical exams and spirometry are done regularly immunizations are administered on Day 28 and a skin tests panel is given on Day 84 Blood samples are collected at study visits during treatment and follow-up to test for immunologyserology parameters chemistry profiles and asthma-related DNA polymorphisms Patients are provided with peak flow meters and must demonstrate their proper use so that a peak expiratory flow PEF diary and a symptoms diary can be maintained Selected sites measure exhaled nitric oxide and collect induced sputum samples Assessments for adverse events are conducted at 16 and 40 weeks following the first study drug treatment
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: