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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06742736

Acronym

EROS+CP (US)

Enrollment

13000

Registered

2024-12-19

Start date

2024-05-31

Completion date

2024-09-30

Last updated

2025-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD, Chronic Obstructive Pulmonary Disease, Retrospective, Real-World Effectiveness

Brief summary

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

Interventions

DRUGBGF

BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Annualized COPD Exacerbation Event Rate	Annualized rates from index exacerbation through end of data availability, mean follow-up 462 days	Annualized rates of COPD exacerbation events observed from index date (qualifying exacerbation event) through study completion (or until end of data availability; mean follow-up 462 days

Secondary

Measure	Time frame	Description
Annualized Cardiopulmonary Event Rate	Annualized rates from index exacerbation through end of data availability; mean follow-up 462 days	Annualized rates of cardiopulmonary events observed from index date (qualifying exacerbation event) through study completion (until end of data availability)

Other

Measure	Time frame	Description
Annualized rate of all-cause mortality	Annualized incidence of mortality during follow-up period until end of data availability; mean follow-up 462 days	Annualized incidence of all-cause mortality observed from index date (qualifying exacerbation event) through study completion (until end of data availability; mean follow-up 462 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026