Exacerbations and Real-World Outcomes Among Patients With Chronic Obstructive Pulmonary Disease Following Severe Exacerbation

Exacerbations and Real-World Outcomes Among Patients With Chronic Obstructive Pulmonary Disease Following Severe Exacerbation (MITOS:EROS+DISCHARGE)

This real-world retrospective study will use de-identified administrative claims data and will examine patients with a diagnosis of COPD who have experienced a qualifying severe disease exacerbation and received subsequent treatment with BGF. Agreed COPD patient data from the Inovalon MORE2 Registry® and Centers for Medicare & Medicaid Services (CMS) 100% Medicare Fee for Service (FFS) database spanning from January 1, 2021 to the most recently available data (September 30th, 2024 for the MORE2 database, and December 31st, 2023 for the Medicare FFS database) will be used for this analysis. All patients will be required to present at least one prescription claim for BGF. Patients will also be required to show evidence of a qualifying severe COPD exacerbation event during the 180-day period preceding initiation of BGF. Index date will be set as the date of discharge from the qualifying severe exacerbation event.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: BGF- BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL

• Study Type: Observational
• Enrollment (Actual): 3598

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Gaithersburg, Maryland, United States, 20878
      • AstraZeneca

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

The study population is selected to allow a clear comparison of outcomes according to the timing of BGF initiation following a severe COPD exacerbation. The overall sample will include adult (aged ≥40) patients with COPD who have experienced a qualifying severe COPD exacerbation and received treatment with BGF within 6 months. Patients should not have prior single inhaler triple therapy (SITT) use during the available history of patients' data preceding the qualifying index severe exacerbation and prior to initiating BGF treatment.

Description

Inclusion Criteria:

• ≥ 1 prescription(s) fill for BGF on or following January 1, 2021

• Patients must have evidence of a severe qualifying exacerbation event.

  • The qualifying severe exacerbation event discharge date must occur within the 180-day period preceding the initiation of BGF for classification of patients into prompt or delayed initiators of BGF.
  • The discharge date of the first (earliest) observed qualifying index exacerbation event will be set as the index date
• ≥ 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 date

Exclusion Criteria:

• Presence of cancer diagnoses other than basal or squamous cell skin cancer during the baseline period preceding the index date or entire follow-up period
• Presence of ≥2 claims with a diagnosis of interstitial fibrosis or sarcoidosis diagnoses during the period preceding the index date or entire follow-up period
• Presence of SITT at any time during the entire available history of patients' data preceding the index date through BGF initiation

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prompt; Patients initiating BGF within 30-days of exacerbation	Drug: BGF- BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL; This is a real-world observational study evaluating the timing of BGF, post discharge.
Delayed; Patients initiating BGF within 31-180 days of exacerbation	Drug: BGF- BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL; This is a real-world observational study evaluating the timing of BGF, post discharge.

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	180 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)	180 days
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)	180 days

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Della Varghese, PhD, AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2025
• Primary Completion (Actual): November 28, 2025
• Study Completion (Actual): November 28, 2025

Study Registration Dates

• First Submitted: October 28, 2025
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: D5980R00121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR