Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096954
Status:
COMPLETED
Last Update Posted:
2017-06-14
First Post:
2004-11-17
Brief Title:
A Prospective Randomized Double-Blind Study of the Efficacy of Omalizumab Xolair in Atopic Asthmatics With Good Lung Capacity Who Remain Difficult to Treat EXACT
Sponsor:
Genentech Inc
Organization:
Genentech Inc
Study Overview
Official Title:
A Prospective Randomized Double-Blind Study of the Efficacy of Omalizumab Xolair in Atopic Asthmatics With Good Lung Capacity Who Remain Difficult to Treat EXACT
Status:
COMPLETED
Status Verified Date:
2017-05
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:
EXACT
Brief Summary:
This was a multicenter parallel-group double-blind randomized placebo-controlled study that enrolled 333 subjects These subjects were 12-75 years old with atopic asthma had elevated serum total Immunoglobulin E IgE had a baseline forced expiratory volume in 1 second FEV1 80 predicted and were on inhaled corticosteroids with or without other controller asthma medications eg long-acting β2-agonists LABAs leukotriene receptor antagonist LTRA or immunotherapy
Detailed Description:
None
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