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Exacerbations Among Patients Receiving Breztri (EROS Study)
Exacerbations Among Patients Receiving Breztri (EROS Study)

NCT06514144

CompletedN/A

Sponsor: AstraZeneca

Conditions: Pulmonary Disease, Chronic Obstructive, Retrospective Studies

Interventions: BGF

Countries: United States

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.

Eligibility overview

Sex: ALL

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

* ≥ 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 Criteria:

* 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
Locations (1)
  • Wilmington, Delaware, United States