Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422078
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-15
Brief Title:
A Non-interventional Prospective Study With Benralizumab
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Non-interventional Prospective Study With Benralizumab to Investigate Clinical Outcome Based on Standard of Care Medication in Real-life
Status:
RECRUITING
Status Verified Date:
2024-09
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:
AIR POWER
Brief Summary:
This is a prospective non-interventional single-arm multicenter study to investigate asthma control and health-related quality of life HRQL lung function and asthma medication intake in severe eosinophilic asthma patients treated with benralizumab in a real-life setting in Germany
Detailed Description:
This is a prospective observational study to investigate the asthma control and health realted quality of life HRQL of benralizumab treated patients in routine clinical practice their asthma medication intake and their changes in asthma medication during the study up to 52 weeks
The asthma control will be analyzed by using the Asthma Control Test ACT and the Asthma Impairment and Risk Questionnaire AIRQ at different timepoints during the study period either collected by the investigator or self-reported by the patient In addition health realted quality of life will be assessed at baseline and routine follow-up visits using the mini Asthma Quality of Life Questionnaire miniAQLQ which is collected by the investigator To investigate the medication intake and assess the changes in asthma medication the patients will record their weekly medication intake in a paper-based or an electronic medication diary throughout the study
The asthma control will be analyzed by using the Asthma Control Test ACT and the Asthma Impairment and Risk Questionnaire AIRQ at different timepoints during the study period either collected by the investigator or self-reported by the patient In addition health realted quality of life will be assessed at baseline and routine follow-up visits using the mini Asthma Quality of Life Questionnaire miniAQLQ which is collected by the investigator To investigate the medication intake and assess the changes in asthma medication the patients will record their weekly medication intake in a paper-based or an electronic medication diary throughout the study
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