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

CompletedN/A

Sponsor: AstraZeneca

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: BGF

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 40 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (1)

Wilmington, Delaware, United States