Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-02-25 @ 5:34 PM
Study NCT ID:
NCT01397760
Status:
UNKNOWN
Last Update Posted:
2011-07-20
First Post:
2011-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Study for Description of The Use Of Omalizumab In Patients With Difficult To Control Asthma
Sponsor:
Fiks, Iara Nely, M.D.
Organization:
Study Overview
Official Title:
Retrospective Study for Description of The Use Of Omalizumab In Patients With Difficult To Control Asthma
Status:
UNKNOWN
Status Verified Date:
2011-07
Last Known Status:
NOT_YET_RECRUITING
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 of this study is do describe the experience in the use of omalizumabe, in a real life scenario, in uncontrolled severe asthmatic patients attended in specialist outpatient clinics, and its efficacy and safety. The efficacy of omalizumab in the population observed will be evaluated as reduction of uncontrolled asthma related events, i.e. exacerbations, emergency dept. visits, hospitalization and asthma-related treatment (decrease of asthma medication).
Detailed Description:
Omalizumab is indicated in children over 6 years of age, with diagnosis of difficult to control asthma, presenting a component of atopy demonstrated preferably positive skin tests (prick test) or in vitro reactivity (rast) allergens common inhalants. Patients must also present the total serum IgE levels between 30 and 700UI/mL. Children until 12 years the IgE level is between 30 and 300 IU/ml.
Study Oversight
Has Oversight DMC:
False
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?: