EXACERBATIONS AND REAL-WORLD OUTOMES INCLUDING CARDIOPULMONARY EVENTS AMONG PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (MITOS: EROS+CP US Study) (EROS+CP (US))

AstraZeneca

Status

Completed

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Drug: BGF

Study type

Observational

Funder types

Industry

Identifiers

NCT06742736

D5980R00095

Details and patient eligibility

About

A retrospective real-world data study, assessing the relationship between the timing of Budesonide/Glycopyrrolate/Formoterol initiation following an exacerbation and the occurrence of subsequent exacerbations, severe cardiopulmonary events and other real-world outcomes in the United States

Enrollment

13,000 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1 prescription(s) fill for BGF on or following July 24, 2020 (date of BGF approval in the United States)
- Patients must have evidence a qualifying exacerbation events which, per local or global guidelines, would qualify a patient to have treatment escalated or initiated to triple therapy. The qualifying exacerbation event must occur within the 12-month period preceding the initiation of BGF but occurring on or following local BGF commercial availability (July 24, 2020) and includes either of the following
12 months of continuous health plan enrollment preceding the qualifying index exacerbation event date ('baseline' period)
1 day of continuous enrollment following the qualifying index exacerbation date
- Age ≥ 40 years on the qualifying index exacerbation event

Exclusion criteria

Presence of cancer diagnoses other than basal or squamous cell skin cancer during the baseline or follow-up periods
Presence of interstitial fibrosis, sarcoidosis, or pulmonary embolism diagnoses during the baseline or follow-up periods
Presence of triple therapy SITT during the baseline period through BGF initiation