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

EXACERBATIONS AND REAL-WORLD OUTOMES INCLUDING CARDIOPULMONARY EVENTS AMONG PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE INITIATING BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL (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

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: BGF

• Study Type: Observational
• Enrollment (Actual): 13000

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • AstraZeneca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The overall sample will include adult (aged 40+) COPD patients who have experienced a qualifying COPD exacerbation and eventually received treatment with BGF. Patients should not have prior single inhaler triple therapy (SITT) use during the 12-month period-baseline prior to the qualifying index exacerbation and prior to initiating BGF treatment.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prompt; PATIENTS INITIATING BGF WITHIN 30-DAYS OF EXACERBATION	Drug: BGF; BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL; Other Names: BREZTRI
DELAYED; PATIENTS INITIATING BGF WITHIN 31-180 DAYS OF EXACERBATION	Drug: BGF; BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL; Other Names: BREZTRI
VERY DELAYED; PATIENTS INITIATING BGF WITHIN 181-365 DAYS OF EXACERBATION	Drug: BGF; BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL; Other Names: BREZTRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualized COPD Exacerbation Event Rate	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	Annualized rates from index exacerbation through end of data availability, mean follow-up 462 days

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualized rate of all-cause mortality	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	Annualized incidence of mortality during follow-up period until end of data availability; mean follow-up 462 days

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Michael Pollack, MS, AstraZeneca

Publications and helpful links

Helpful Links

• D5980R00095 Redacted CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2024
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): December 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: COPD; Chronic Obstructive Pulmonary Disease; Retrospective; Real-World Effectiveness
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: D5980R00095