EXACERBATIONS AND REAL-WORLD OUTOMES AMONG PATIENTS WITH COPD INITIATING BREZTRI (EROS+CP Japan Study) (EROS+CP-Japan)

EXACERBATIONS AND REAL-WORLD OUTOMES INCLUDING CARDIOPULMONARY EVENTS AMONG PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE INITIATING BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL (MITOS: EROS+CP Japan Study)

A retrospective real-world data study, assessing the relationship between the timing of Budesonide/Glycopyrrolate/Formoterol initiation following an exacerbation and the occurrence of subsequent exacerbations, severe cardiopulmonary events and other real-world outcomes in Japan

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: BGF

• Study Type: Observational
• Enrollment (Actual): 3402

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • AstraZeneca

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

The overall study population will include adult patients (aged ≥ 40) with COPD in Japan who have experienced a qualifying COPD exacerbation (defining the index date) on or after the BGF launch in Japan (i.e., 04 September 2019) for which triple therapy (i.e., BGF) could have been initiated per local or global guidelines

Description

Inclusion Criteria:

• Diagnosis of COPD (at any position) before or on the index date

  • 1 dispensation of BGF on or following the launch date of BGF in Japan

• Patients must have evidence of at least one qualifying COPD exacerbation event, which qualify the initiation of triple therapy. The exacerbation event must occur within the 12-month period preceding BGF initiation and on or after BGF launch in Japan (i.e., 04 September 2019). The earliest qualifying COPD exacerbation event will be set as the index date.

  • 12 months of continuous health plan enrollment preceding the qualifying COPD exacerbation date
  • 1 day of continuous enrollment following the qualifying COPD exacerbation date
• Age ≥ 40 years on the qualifying COPD exacerbation date

Exclusion Criteria:

• Presence of ≥ 2 records of respiratory cancer diagnoses occurring at least 1 month apart during the 12-month baseline period preceding the qualifying COPD exacerbation or during the follow-up period
• Presence of ≥ 1 dispensation of SITT during the 12-month baseline period preceding the index date through BGF initiation
• Patients who only have 1 moderate COPD exacerbation in 12-months period prior to BGF initiation with no dispensation of long-acting inhaled COPD maintenance treatment during the 12-months baseline period preceding the qualifying COPD exacerbation.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
DELAYED; PATIENTS INITIATING BGF WITHIN 31-180 DAYS OF EXACERBATION	Drug: BGF; BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL
PROMPT; PATIENTS INITIATING BGF WITHIN 30-DAYS OF EXACERBATION	Drug: BGF; BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL
VERY DELAYED; PATIENTS INITIATING BGF BETWEEN 181 AND 365 DAYS AFTER EXACERBATION	Drug: BGF; BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualized COPD Exacerbation Event Rate	Annualized rates of COPD exacerbation events observed from index date (qualifying exacerbation event) through study completion (or until end of data availability with a median follow-up of 713 days	Annualized rates from index exacerbation through end of data availability; median follow-up 713 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualized Cardiopulmonary Event Rate	Annualized rates of cardiopulmonary events observed from index date (qualifying exacerbation event) through study completion (until end of data availability) with median follow-up time of 713 days.	Annualized rates from index exacerbation through end of data availability with median follow-up of 713 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to and rate of all-cause mortality	Annualized incidence of all-cause mortality observed from index date (qualifying exacerbation event) through study completion (until end of data availability with median follow-up time of 713 days.	Annualized incidence of mortality from index exacerbation through end of data availability; median follow-up 713 days

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• D5980R00093_CSR synopsis_Redacted

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2024
• Primary Completion (Actual): October 18, 2024
• Study Completion (Actual): October 18, 2024

Study Registration Dates

• First Submitted: July 29, 2025
• First Submitted That Met QC Criteria: July 29, 2025
• First Posted (Actual): August 5, 2025

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: COPD; Chronic Obstructive Pulmonary Disease; Retrospective; Real-World Effectiveness
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: D5980R00093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.