Exacerbations Among Patients Receiving Breztri (EROS Study)
- Registration Number
- NCT06514144
- Lead Sponsor
- AstraZeneca
- 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 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.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2409
- ≥ 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Treatment Initiation BGF Initiation of treatment following exacerbation classified as prompt, delayed or very delayed.
- Primary Outcome Measures
Name Time Method COPD Exacerbation events Annualized rates from index exacerbation through end of data availability, an average follow-up time of 331 days. 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.
- Secondary Outcome Measures
Name Time Method Healthcare resource utilization Annualized rates from index exacerbation through end of data availability, an average follow-up time of 331 days. 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.
Healthcare costs Annualized costs from idex exacerbation through end of data availability, an average follow-up time of 331 days. 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.
Trial Locations
- Locations (1)
AstraZeneca
🇺🇸Wilmington, Delaware, United States