Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00079937
Status:
COMPLETED
Last Update Posted:
2012-04-11
First Post:
2004-03-18
Brief Title:
Efficacy and Safety of Omalizumab in Children 6 - 12 Years With Moderate-severe Inadequately Controlled Allergic Asthma
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A 1 Year Randomized Double-blind Parallel-group Placebo-controlled Multicenter Evaluation of Efficacy Safety Pharmacokinetics and Pharmacodynamics of Omalizumab in Children 6 - 12 Years With Moderate-severe Persistent Inadequately Controlled Allergic Asthma
Status:
COMPLETED
Status Verified Date:
2012-04
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:
A substance called immunoglobulin E IgE which is naturally produced by our body has a key role in generating asthma attacks In patients with allergies there is an exaggerated production of IgE in response to specific substances such as pollens Omalizumab is a new drug that inactivates IgE This study tested the safety and efficacy of omalizumab against asthma attacks in children with allergic asthma
Detailed Description:
This study was designed to provide one year efficacy and safety data for subcutaneous SC omalizumab compared to placebo in children 6 to 12 years with moderate to severe persistent asthma who have inadequate asthma control despite treatment according to National Heart Lung and Blood Institute NHLBI step 3 or 4 at least medium dose inhaled corticosteroids with or without other controller asthma medications
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