Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04648839
Status:
COMPLETED
Last Update Posted:
2022-08-19
First Post:
2020-10-05
Brief Title:
Observational Retrospective Study on Clinical Outcomes of Patients Receiving Benralizumab in Spain
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Observational Retrospective Study to Characterise and Assess Clinical Outcomes of Patients Receiving Benralizumab After Marketing Approval in Spain
Status:
COMPLETED
Status Verified Date:
2022-08
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:
ORBE-II
Brief Summary:
Primary Objectives
1 To describe the demographic and baseline characteristics in patients with severe eosinophilic asthma in Spain who received at least one dose of Benralizumab after its marketing authorization
2 To describe background treatment patterns of severe eosinophilic asthma patients at baseline and after the index date benralizumab initiation
This is a descriptive observational multi-centre longitudinal retrospective cohort study in adults patients 18 years with severe asthma maintenance treatment with high dose inhaled corticosteroids combined with long-acting agonist β2 and eosinophilic phenotype who at the discretion of the physician received benralizumab accordingly to the clinical practice in the period after the marketing authorization of benralizumab in Spain on January 1st 2019
1 To describe the demographic and baseline characteristics in patients with severe eosinophilic asthma in Spain who received at least one dose of Benralizumab after its marketing authorization
2 To describe background treatment patterns of severe eosinophilic asthma patients at baseline and after the index date benralizumab initiation
This is a descriptive observational multi-centre longitudinal retrospective cohort study in adults patients 18 years with severe asthma maintenance treatment with high dose inhaled corticosteroids combined with long-acting agonist β2 and eosinophilic phenotype who at the discretion of the physician received benralizumab accordingly to the clinical practice in the period after the marketing authorization of benralizumab in Spain on January 1st 2019
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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