Skip to main content
OpenTrials
Completed

NCT Number: NCT06742736

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AstraZeneca

Wilmington, Delaware, 19803, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BGF

Drug

BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL

Other names: BREZTRI

Primary outcomes

  1. Annualized COPD Exacerbation Event Rate

    Time frame: 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 outcomes

  1. Annualized Cardiopulmonary Event Rate

    Time frame: 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 outcomes

  1. Annualized rate of all-cause mortality

    Time frame: 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: EROS+CP (US)

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 19, 2024
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.