NCT06514144

Exacerbations Among Patients Receiving Breztri (EROS Study)

Exacerbations and Real-World Outcomes Among Chronic Obstructive Pulmonary Disease Patients Receiving Breztri (EROS Study)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,409 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Disease
• Chronic Obstructive
• Retrospective Studies

Interventions

Type	Name	Description
DRUG	BGF	budesonide/glycopyrrolate/formoterol fumarate

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-03-07
• Completion: 2023-03-07
• First posted: 2024-07-23
• Last updated: 2024-12-13

Locations

1 site across 1 country: United States