Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00329381
Status:
COMPLETED
Last Update Posted:
2008-06-04
First Post:
2006-05-23
Brief Title:
Safety and Efficacy Study of Omalizumab Given Prior to Immunotherapy
Sponsor:
University of Mississippi Medical Center
Organization:
University of Mississippi Medical Center
Study Overview
Official Title:
A26-wkRandomizedDble-BlindedParallel-GrpPlacebo-ControlledMulti-Centered Study to Evalthe Effect of XolairOmalizumabon Improving the Tolerability of SpecImmunotherapy in Patients With at Least Mod Persistent Allergic Asthma Inadequately Controlled wInhaled Corticosteroids
Status:
COMPLETED
Status Verified Date:
2007-01
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:
In patients with at least moderate persistent allergic asthma controlled with inhaled steroids omalizumabadministered per US product label when compared to placebo will provide the participants with significantly improved tolerability of specific allergen immunotherapy allergy shots administered per a cluster schedulerapid build up method
Detailed Description:
Omalizumab is an FDA approved anti-IgE drug used to treat allergic asthma This study is designed to give omalizumab 13 weeks prior to administering rapid build up of specific allergy shot with an overlap of omalizumab and cluster therapy for 3 weeks The cluster therapy will take 4 week to complete with maintenance dosage lasting an additional 6 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