EXACERBATIONS AND REAL-WORLD OUTOMES AMONG PATIENTS WITH COPD INITIATING BREZTRI (EROS+CP Japan Study)
Completed
Conditions studied: Pulmonary Disease, Chronic Obstructive
In brief
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
Key facts
- Study ID
- NCT07103642
- Run by
- AstraZeneca
- People needed
- 3402
- Starts
- 2024-08-15
- Expected to finish
- 2024-10-18
- Last updated by the study team
- 2025-08-15
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
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.
Where it is running
- AstraZeneca — Wilmington, Delaware, United States
Full record on ClinicalTrials.gov
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