MedDataX Logo

Exacerbations Among Patients Receiving Breztri (EROS Study)

NCT ID: NCT06514144

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2409 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-03-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Disease Chronic Obstructive Retrospective Studies

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

COPD Delayed therapy Exacerbations Triple therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment Initiation

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

BGF

Intervention Type DRUG

budesonide/glycopyrrolate/formoterol fumarate

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BGF

budesonide/glycopyrrolate/formoterol fumarate

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Breztri

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael Pollack, MS

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

AstraZeneca

Wilmington, Delaware, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5980R00079&attachmentIdentifier=ed83ff39-7b76-4b7c-9791-166c16f2664e&fileName=EROS_(D5980R00079)_CSR_Synopsis_Redacted2.pdf&versionIdentifier=

CSR Synopsis

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D5980R00079

Identifier Type: -

Identifier Source: org_study_id