Ignite Creation Date:
2024-05-05 @ 1:26 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001893
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
1999-11-03
Brief Title:
Study of TNFRFc Enbrel in the Treatment of Asthma
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Clinical Trial of TNFRFc in a Segmental Allergen Challenge Model of Asthma
Status:
COMPLETED
Status Verified Date:
2008-06-13
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 proposed study is a phase II clinical trial of TNFRFc therapy in a segmental allergen bronchoprovocation model of atopic asthma The goal of this study is to assess whether inhibition of tumor necrosis factor TNF bioactivity can attenuate airway inflammation in mild-to-moderate allergic asthmatics This protocol will utilize a randomized double-blind placebo-controlled trial design TNF bioactivity will be inhibited via systemic administration eg subcutaneous injection of a dimeric fusion protein consisting of the extracellular ligand binding domain of the 75-kilodalton TNF receptor linked to the Fc portion of human IgG1 TNFRFc Immunex The data generated by this study will address the utility of anti-TNF therapy for patients with asthma
Detailed Description:
The proposed study is a phase II clinical trial of TNFRFc therapy in a segmental allergen bronchoprovocation model of atopic asthma The goal of this study is to assess whether inhibition of tumor necrosis factor TNF bioactivity can attenuate airway inflammation in mild-to-moderate allergic asthmatics This protocol will utilize a randomized double-blind placebo-controlled trial design TNF bioactivity will be inhibited via systemic administration eg subcutaneous injection of a dimeric fusion protein consisting of the extracellular ligand- binding domain of the 75-kilodalton TNF receptor linked to the Fc portion of human IgG1 TNFRFc Immunex The data generated by this study will address the utility of anti-TNF therapy for patients with 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-H-0140 | None | None | None |