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

AstraZeneca

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: BGF

Study type: Observational

Funder types: Industry

Identifiers

NCT07103642

D5980R00093

Details and patient eligibility

About

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

Enrollment: 3,402 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

3,402 participants in 3 patient groups

PROMPT

Description:

PATIENTS INITIATING BGF WITHIN 30-DAYS OF EXACERBATION

Treatment:

Drug: BGF

DELAYED

Description:

PATIENTS INITIATING BGF WITHIN 31-180 DAYS OF EXACERBATION

Treatment:

Drug: BGF

VERY DELAYED

Description:

PATIENTS INITIATING BGF BETWEEN 181 AND 365 DAYS AFTER EXACERBATION

Treatment:

Drug: BGF