Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06348407
Status:
RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-03-21
Brief Title:
A Clinical Study of Omalizumab in the Treatment of Allergic AsthmaESSENCE
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
Official Title:
The Efficacy and Safety of Omalizumab in the Treatment of Moderate to Severe Allergic AsthmaA Retrospective Single-center Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-03
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:
ESSENCE
Brief Summary:
Allergic asthma being the most widespread and easily identifiable phenotype accounting for 60-80 of casesPrevious studies have reported that nearly 90 of patients with severe asthma were cases of allergic asthma in which Immunoglobulin E IgE plays a critical roleOmalizumab was approved as an anti-IgE humanized monoclonal antibody for the treatment of patients with poorly controlled moderate-to-severe asthma and was the first targeted drug used in the field of asthma treatmentThe drug was launched in mainland China in August 2017whereasthe clinical application experience effects and relevant data in the domestic population still lackingThe aim of this study was to observe the efficacy and safety of omalizumab and to investigate whether baseline clinical characteristics and biomarkers can predicted response and adherence to treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None