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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.
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 disease exacerbations of people with COPD.
The study used administrative claims data in the US sourced from the Inovalon MORE2 Registry® between July 2019 and March 2022. Inclusion required one of the following qualifying exacerbation events: ≥1 severe, ≥2 moderate, or ≥1 moderate exacerbation while on other maintenance treatment, be age ≥40 at the index date, and have ≥90 days of continuous enrollment following the index date.
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. Statistical analyses included both descriptive and multivariable approaches- negative binomial regression models to estimate the effect of each 30-day delay on the number of exacerbations and a gamma model with a log-link to estimate the effects on the incremental increase in COPD-related costs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Initiation | Initiation of treatment following exacerbation classified as prompt, delayed or very delayed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGF | Drug | budesonide/glycopyrrolate/formoterol fumarate |
|
| Measure | Description | Time Frame |
|---|---|---|
| COPD Exacerbation events | Annualized rates of COPD exacerbation events observed from index date (qualifying exacerbation event) through study completion (until end of data availability), an average follow-up time of 331 days. | Annualized rates from index exacerbation through end of data availability, an average follow-up time of 331 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare resource utilization | Annualized rates of health care services observed (e.g., inpatient visits, ER visits) from index date (qualifying exacerbation event) through study completion (until end of data availability), an average follow-up time of 331 days. | Annualized rates from index exacerbation through end of data availability, an average follow-up time of 331 days. |
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Inclusion Criteria:
Exclusion Criteria:
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People with COPD who experienced a COPD exacerbation event and were subsequently initiated on therapy with budesonide/glycopyrrolate/formoterol fumarate (BGF); sourced from secondary administrative claims data between July 2020 through March 2022.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Pollack, MS | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AstraZeneca | Wilmington | Delaware | 19850 | United States |
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| Label | URL |
|---|---|
| CSR Synopsis | View source |
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
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| Healthcare costs | Annualized costs of health care services observed (e.g., total health care costs, total-COPD related costs) from index date (qualifying exacerbation event) through study completion (until end of data availability), an average follow-up time of 331 days. | Annualized costs from idex exacerbation through end of data availability, an average follow-up time of 331 days. |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |