Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06514144
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-03-18
Brief Title:
Exacerbations Among Patients Receiving Breztri EROS Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Exacerbations and Real-World Outcomes Among Chronic Obstructive Pulmonary Disease Patients Receiving Breztri EROS Study
Status:
COMPLETED
Status Verified Date:
2024-06
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:
None
Brief Summary:
EROS was a retrospective analysis of people with COPD using the MORE2 Registry Inclusion required 1 severe 2 moderate or 1 moderate exacerbation while on other maintenance treatment Primary outcomes were the rate of COPD exacerbations and healthcare costs for those that received BGF promptly The effect of each 30-day delay in initiation of BGF was estimated using a multivariable negative binomial regression model
Detailed Description:
EROS was a retrospective real-world evidence claims analysis study assessing the relationship between the timing of Breztri Aerosphere following an exacerbation and the appearance of subsequent disease exacerbations of people with COPD
The study used administrative claims data in the US sourced from the Inovalon MORE2 Registry between July 2019 and March 2022 Inclusion required one of the following qualifying exacerbation events 1 severe 2 moderate or 1 moderate exacerbation while on other maintenance treatment be age 40 at the index date and have 90 days of continuous enrollment following the index date
Primary outcomes were the rate of COPD exacerbations and healthcare costs for those that received BGF promptly The effect of each 30-day delay in initiation of BGF was estimated using a multivariable negative binomial regression model Statistical analyses included both descriptive and multivariable approaches- negative binomial regression models to estimate the effect of each 30-day delay on the number of exacerbations and a gamma model with a log-link to estimate the effects on the incremental increase in COPD-related costs
The study used administrative claims data in the US sourced from the Inovalon MORE2 Registry between July 2019 and March 2022 Inclusion required one of the following qualifying exacerbation events 1 severe 2 moderate or 1 moderate exacerbation while on other maintenance treatment be age 40 at the index date and have 90 days of continuous enrollment following the index date
Primary outcomes were the rate of COPD exacerbations and healthcare costs for those that received BGF promptly The effect of each 30-day delay in initiation of BGF was estimated using a multivariable negative binomial regression model Statistical analyses included both descriptive and multivariable approaches- negative binomial regression models to estimate the effect of each 30-day delay on the number of exacerbations and a gamma model with a log-link to estimate the effects on the incremental increase in COPD-related costs
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: