Exacerbations Among Patients Receiving Breztri (EROS Study)

NCT06514144 | Completed

• 1 other identifier: D5980R00079
• Study Type: observational
• Target: 2,409
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease; Chronic Obstructive; Retrospective Studies

Keywords

COPD; Delayed therapy; Exacerbations; Triple therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Healthcare resource utilization

  Annualized rates from index exacerbation through end of data availability, an average follow-up time of 331 days.

• Healthcare costs

  Annualized costs from idex exacerbation through end of data availability, an average follow-up time of 331 days.

Study Arms (1)

Treatment Initiation

Initiation of treatment following exacerbation classified as prompt, delayed or very delayed.

Drug: BGF

Interventions

BGF DRUG

budesonide/glycopyrrolate/formoterol fumarate

Also known as: Breztri

Treatment Initiation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

AstraZeneca

Wilmington, Delaware, 19850, United States

Location

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Lung Diseases; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Pollack, MS

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: July 23, 2024
• Study Start: October 1, 2022
• Primary Completion: March 7, 2023
• Study Completion: March 7, 2023
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

US (1)