Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06283966
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-21
Brief Title:
A Study Evaluating the Efficacy of Budesonide Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Randomized Double-blind Parallel Group Multi-center Phase III Study to Assess the Efficacy of Budesonide Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler Relative to Glycopyrronium and Formoterol Fumarate MDI on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease THARROS
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THARROS
Brief Summary:
This study will evaluate the effect of triple ICSLAMALABA therapy with BGF MDI 32014496 μg on cardiopulmonary outcomes relative to LAMALABA therapy with GFF MDI 14496 μg in a population with COPD and elevated cardiopulmonary risk
Detailed Description:
This is a Phase III randomized double-blind parallel group multi-center event-driven study comparing BGF MDI 32014496 μg BID with GFF MDI 14496 μg BID in participants with COPD who are at risk of a cardiopulmonary event
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?:
None
Is an FDA AA801 Violation?:
None