Exacerbations Among Patients Receiving Breztri (EROS Study)
Completed
Conditions studied: Pulmonary Disease, Chronic Obstructive, Retrospective Studies
In brief
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 outcomes were the rate of COPD exacerbations and healthcare costs for those that received BGF promptly. The effect of each 30-day delay in initiation of BGF was estimated using a multivariable negative binomial regression model.
Key facts
- Study ID
- NCT06514144
- Run by
- AstraZeneca
- People needed
- 2409
- Starts
- 2022-10-01
- Expected to finish
- 2023-03-07
- Last updated by the study team
- 2024-12-13
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥ 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
You may not qualify if…
- 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
Where it is running
- AstraZeneca — Wilmington, Delaware, United States
Full record on ClinicalTrials.gov
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