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

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: BGF

• Registration Number: NCT07103642
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-15
• Primary Completion: 2024-10-18
• Study Completion: 2024-10-18
• Study First Submitted: 2025-07-29
• Study First Submitted QC: 2025-07-29
• Status Verified: 2025-08
• Study First Posted: 2025-08-05
• Last Update Submitted: 2025-08-12
• Last Update Posted: 2025-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3402

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PROMPT	BGF	PATIENTS INITIATING BGF WITHIN 30-DAYS OF EXACERBATION
DELAYED	BGF	PATIENTS INITIATING BGF WITHIN 31-180 DAYS OF EXACERBATION
VERY DELAYED	BGF	PATIENTS INITIATING BGF BETWEEN 181 AND 365 DAYS AFTER EXACERBATION

Primary Outcome Measures

Name	Time	Method
Annualized COPD Exacerbation Event Rate	Annualized rates from index exacerbation through end of data availability; median follow-up 713 days	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

Secondary Outcome Measures

Name	Time	Method
Annualized Cardiopulmonary Event Rate	Annualized rates from index exacerbation through end of data availability with median follow-up of 713 days	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.

Trial Locations

Locations (1)

AstraZeneca; 🇺🇸 Wilmington, Delaware, United States