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

NCT06742736

CompletedN/A

Sponsor: AstraZeneca

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: BGF

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 40 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (1)

Wilmington, Delaware, United States