Exacerbations Among Patients Receiving Breztri (EROS Study)

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease; Chronic Obstructive; Retrospective Studies
• Intervention / Treatment: Drug: BGF

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.

• Study Type: Observational
• Enrollment (Actual): 2409

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Wilmington, Delaware, United States, 19850
      • AstraZeneca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

People with COPD who experienced a COPD exacerbation event and were subsequently initiated on therapy with budesonide/glycopyrrolate/formoterol fumarate (BGF); sourced from secondary administrative claims data between July 2020 through March 2022.

Description

Inclusion Criteria:

• ≥ 1 prescription fill for BGF on or following July 24th, 2020 (Breztri approval date);
• Evidence of any of the following exacerbation patterns within the 12-month period preceding the initiation of BGF, all index exacerbation events must occur following BGF approval: (1) one moderate exacerbation (the exacerbation must occur following approval of Breztri) with presence of other inhaled therapy, (2) two moderate exacerbations (the second exacerbation must occur following approval of Breztri) without the presence of other inhaled therapy, or (3) Severe Exacerbation- Inpatient COPD hospitalization
• ≥ 12 months of continuous enrollment preceding the index exacerbation date
• ≥ 90 days of continuous enrollment following the index exacerbation date
• Age ≥ 40 years on the index exacerbation date

Exclusion Criteria:

• Presence of closed triple therapy during the baseline period
• Initiation of BGF 4/1/2022 or later
• Presence of an enrollment gap of more than 14-days from index exacerbation date to BGF initiation date

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment Initiation; Initiation of treatment following exacerbation classified as prompt, delayed or very delayed.	Drug: BGF; budesonide/glycopyrrolate/formoterol fumarate; Other Names: Breztri

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COPD Exacerbation events	Annualized rates of COPD exacerbation events observed from index date (qualifying exacerbation event) through study completion (until end of data availability), an average follow-up time of 331 days.	Annualized rates from index exacerbation through end of data availability, an average follow-up time of 331 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare resource utilization	Annualized rates of health care services observed (e.g., inpatient visits, ER visits) from index date (qualifying exacerbation event) through study completion (until end of data availability), an average follow-up time of 331 days.	Annualized rates from index exacerbation through end of data availability, an average follow-up time of 331 days.
Healthcare costs	Annualized costs of health care services observed (e.g., total health care costs, total-COPD related costs) from index date (qualifying exacerbation event) through study completion (until end of data availability), an average follow-up time of 331 days.	Annualized costs from idex exacerbation through end of data availability, an average follow-up time of 331 days.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Michael Pollack, MS, AstraZeneca

Publications and helpful links

Helpful Links

• CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): March 7, 2023
• Study Completion (Actual): March 7, 2023

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Estimated): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: COPD; Exacerbations; Triple therapy; Delayed therapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: D5980R00079