Status:
COMPLETED
Exacerbations Among Patients Receiving Breztri (EROS Study)
Lead Sponsor:
AstraZeneca
Conditions:
Pulmonary Disease
Chronic Obstructive
Eligibility:
All Genders
Brief Summary
EROS was a retrospective analysis of people with COPD using the MORE2 Registry®. Inclusion required ≥1 severe, ≥2 moderate, or ≥1 moderate exacerbation while on other maintenance treatment. Primary ou...
Detailed Description
EROS was a retrospective real-world evidence claims analysis study, assessing the relationship between the timing of Breztri Aerosphere following an exacerbation and the appearance of subsequent disea...
Eligibility Criteria
Inclusion
- ≥ 1 prescription fill for BGF on or following July 24th, 2020 (Breztri approval date);
- Evidence of any of the following exacerbation patterns within the 12-month period preceding the initiation of BGF, all index exacerbation events must occur following BGF approval: (1) one moderate exacerbation (the exacerbation must occur following approval of Breztri) with presence of other inhaled therapy, (2) two moderate exacerbations (the second exacerbation must occur following approval of Breztri) without the presence of other inhaled therapy, or (3) Severe Exacerbation- Inpatient COPD hospitalization
- ≥ 12 months of continuous enrollment preceding the index exacerbation date
- ≥ 90 days of continuous enrollment following the index exacerbation date
- Age ≥ 40 years on the index exacerbation date
Exclusion
- Presence of closed triple therapy during the baseline period
- Initiation of BGF 4/1/2022 or later
- Presence of an enrollment gap of more than 14-days from index exacerbation date to BGF initiation date
Key Trial Info
Start Date :
October 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 7 2023
Estimated Enrollment :
2409 Patients enrolled
Trial Details
Trial ID
NCT06514144
Start Date
October 1 2022
End Date
March 7 2023
Last Update
December 13 2024
Active Locations (1)
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1
AstraZeneca
Wilmington, Delaware, United States, 19850