Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-27 @ 11:32 PM
Study NCT ID:
NCT07013760
Status:
RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterize and Assess Clinical Outcomes of Patients Receiving Tezepelumab After Marketing Approval in Spain
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
Observational Retrospective Study to Characterize and Assess Clinical Outcomes of Patients Receiving Tezepelumab After Marketing Approval in Spain
Status:
RECRUITING
Status Verified Date:
2025-12
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:
T-ROSS-II
Brief Summary:
Observational retrospective study to characterize and assess clinical outcomes of patients receiving tezepelumab after marketing approval in Spain
Detailed Description:
T-ROSS-II has been designed to conduct a new observational study to generate additional evidence on the use of tezepelumab in severe asthma patients in routine clinical practice in Spain after its launch.
This is an observational, multi-centre, retrospective, single-arm study in patients 12 years and older with severe asthma.
Approximately 400 patients meeting the study eligibility criteria will be included in the T-ROSS-II.
This is an observational, multi-centre, retrospective, single-arm study in patients 12 years and older with severe asthma.
Approximately 400 patients meeting the study eligibility criteria will be included in the T-ROSS-II.
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?: