Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482508
Status:
COMPLETED
Last Update Posted:
2011-10-25
First Post:
2007-06-04
Brief Title:
Safety and Tolerability of Omalizumab in Poorly Controlled Moderate to Severe Asthma Patients
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
A One Year Open-label Extension Study to Assess Long Term Safety and Tolerability of Omalizumab Treatment in Poorly Controlled Moderate to Severe Allergic Asthma Patients Who Participated in the 52-week CIGE24IA04E1 Study
Status:
COMPLETED
Status Verified Date:
2011-10
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:
This study will assess the safety and tolerability of long-term treatment with omalizumab plus current asthma therapy in patients who participated in and successfully completed the treatment period of study CIGE025IA04E1 Patients who participated in CIGE025IA04E1 were perceived by both the patient and the investigator to have benefited from receiving treatment with omalizumab plus current asthma therapy according to best medical practice
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