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

NCT07103642 | Completed

• 1 other identifier: D5980R00093
• Study Type: observational
• Target: 3,402
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD; Chronic Obstructive Pulmonary Disease; Retrospective; Real-World Effectiveness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Annualized Cardiopulmonary Event Rate

  Annualized rates from index exacerbation through end of data availability with median follow-up of 713 days

Other Outcomes (1)

• Time to and rate of all-cause mortality

  Annualized incidence of mortality from index exacerbation through end of data availability; median follow-up 713 days

Study Arms (3)

PROMPT

PATIENTS INITIATING BGF WITHIN 30-DAYS OF EXACERBATION

Drug: BGF

DELAYED

PATIENTS INITIATING BGF WITHIN 31-180 DAYS OF EXACERBATION

Drug: BGF

VERY DELAYED

PATIENTS INITIATING BGF BETWEEN 181 AND 365 DAYS AFTER EXACERBATION

Drug: BGF

Interventions

BGF DRUG

BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL

DELAYED; PROMPT; VERY DELAYED

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Diagnosis of COPD (at any position) before or on the index date
• 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.
• months of continuous health plan enrollment preceding the qualifying COPD exacerbation date
• day of continuous enrollment following the qualifying COPD exacerbation date
• Age ≥ 40 years on the qualifying COPD exacerbation date

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

AstraZeneca

Wilmington, Delaware, 19803, United States

Location

Related Links

• D5980R00093\_CSR synopsis\_Redacted

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; 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: July 29, 2025
• First Posted: August 5, 2025
• Study Start: August 15, 2024
• Primary Completion: October 18, 2024
• Study Completion: October 18, 2024
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

US (1)