Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422689
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-04-10
Brief Title:
Combination Short-Acting BroNchodilator and Inhaled Corticosteroid Rescue Therapy on Health Outcomes in Routine Care
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
ANCHOR - Assessment of Combination Short-Acting BroNchodilator and Inhaled Corticosteroid Rescue Therapy on Health Outcomes in Routine Care
Status:
RECRUITING
Status Verified Date:
2024-10
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:
ANCHOR
Brief Summary:
ANCHOR is a prospective multi-center phase IV interventional single-arm open-label study of 2000 adult participants with symptomatic asthma requiring the use of rescue therapy aimed to compare the asthma exacerbation rates before and after switching from albuterol or levalbuterol to albuterol plus budesonide inhalation aerosol as rescue therapy
Detailed Description:
This study will primarily compare rates of asthma exacerbation during 12-month pre-switch period and 12-month post switch period among participants with asthma needing a rescue therapy Other outcomes of interest for comparison between the pre- and post-switch periods include asthma-related oral corticosteroids OCS use asthma exacerbation-related hospitalizations emergency department ED visits urgent care visits outpatient visits telehealth visits and asthma-related and asthma exacerbation-related healthcare costs The use of asthma control and rescue medications will be collected to understand treatment patterns in the real-world US context
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None